UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On September 23, 2022, SAB Biotherapeutics, Inc. (the “Company” or “SAB”) made available an updated corporate strategy presentation (the "Presentation") on the Investor Relations section of the Company’s website. A copy of the Presentation is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
The foregoing (including Exhibit 99.1) is being furnished pursuant to Item 7.01 and will not be deemed to be filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise be subject to the liabilities of that section, nor will it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act. The information contained in the Presentation is summary information that should be considered in the context of the Company’s filings with the Securities and Exchange Commission and other public announcements the Company may make by press release or otherwise from time to time.
Cautionary Note Regarding Forward-Looking Statements
Certain statements made herein that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including the development and efficacy of our influenza program, C. diff. program, Type 1 Diabetes program, and other discovery programs, the likelihood that a patent will issue from any patent application, the results, including timing, of the development of SAB-195 (including any IND filing or proposed clinical trials), financial projections and future financial and operating results (including estimated cost savings and cash runway), the outcome of and potential future government and other third-party collaborations or funded programs (including negotiations with the DoD). These statements are based on the current expectations of SAB and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/ Except as otherwise required by law, SAB disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
Item 8.01 Other Events.
On September 23, 2022, SAB Biotherapeutics, Inc. (the “Company” or “SAB”) issued a press release announcing that the Company will present new data on its fully-human polyclonal antibody platform’s ability to maintain its efficacy against multiple variants of several highly mutating viruses at the Options for Control of Influenza (OPTIONS XI) conference, which is hosted by the International Society for Influenza and other Respiratory Virus Diseases (ISIRV) in Belfast, Northern Ireland, from Sept. 26-29, 2022.
A copy of the press release is attached as Exhibit 99.2 to this Current Report on Form 8-K and is hereby incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. The exhibits listed on the Exhibit Index are incorporated herein by reference.
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99.1 |
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99.2 |
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104 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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SAB Biotherapeutics, Inc. |
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September 23, 2022 |
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/s/ Eddie J. Sullivan |
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Eddie J. Sullivan |
ADVANCING A POWERFUL NEW CLASS OF IMMUNOTHERAPEUTIC ANTIBODIES September 2022 © 2022 SAB BIOTHERAPEUTICS, INC. EXHIBIT 99.1
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 PRESIDENT & CEO / CO-FOUNDER 20 years new technology development 25+ years biotech Former Japanese pharma BIO Executive Committee Reproductive physiologist Russell Beyer, MBA, CMA EVP & CHIEF FINANCIAL OFFICER 25+ years Pharma & Fortune 100 Country/region CFO at HP, AstraZeneca, Clorox, Amcor Track record of driving growth, integrations Strategic finance, operations, reporting, planning, IT, Procurement, HR Samuel J. Reich EXECUTIVE CHAIRMAN, BOD 20 years Biopharma Executive and BOD Bioentrepreneur Co-founder Acuity Pharmaceuticals, OPKO Health, Biscayne Neurotherapeutics Molecular Biologist, Inventor, former PENN Alexandra Kropotova, MD EVP & CHIEF MEDICAL OFFICER 20+ years global clinical development Biopharmaceutical R&D leader, Pfizer, Wyeth, Sanofi, Teva Specialty R&D Board member, iBio Contributed to numerous patents & compounds leading portfolios from Phase I to BLA and NDA approvals © 2022 SAB BIOTHERAPEUTICS, INC.
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 corporate position with experienced leadership team and growing infrastructure Leveraged advanced genetic engineering & antibody science to develop Tc bovine-derived fully-human polyclonal antibodies Innovative DiversitAb™ platform produces a new class of targeted fully-human, highly-potent polyclonal antibodies © 2022 SAB BIOTHERAPEUTICS, INC.
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. Information in this presentation, including financial forecasts, should not be considered advice or a recommendation to investors or potential investors in relation to holding, purchasing, or selling securities or other financial products or instruments and does not take into account any particular investment objectives, financial situation or needs. This presentation may contain forward-looking statements including statements regarding our intent, belief, or current expectations with respect to SAB’s businesses and operations, market conditions, results of operations and financial condition, capital adequacy, specific provisions, and risk management practices. Readers are cautioned not to place undue reliance on these forward-looking statements. SAB does not undertake any obligation to update any information herein for any reason or to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof to reflect the occurrence of unanticipated events unless required by law. While due care has been used in the preparation of forecast information, actual results may vary in a materially positive or negative manner and the presentation may contain errors or omissions. Forecasts and hypothetical examples are subject to uncertainty and contingencies outside SAB’s control. Past performance is not a reliable indication of future performance. The forward-looking statements contained or implied in this presentation are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in SAB’s most recent Annual Report on Form 10-K with the Securities and Exchange Commission (the “SEC”) and in other filings that SAB makes with the SEC. Unless otherwise specified, information is current at the date hereof. The SAB logo and other trademarks of SAB appearing in this presentation are the property of SAB. All other trademarks, services marks, and trade names in this presentation are the property of their respective owners. © 2022 SAB BIOTHERAPEUTICS, INC.
Versatile Antibody Platform with Ability to Capture Multiple Modalities 5 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-human, targeted, high-potency –Multivalent, multi-targeted Human Immunoglobulin –Specifically targeted –Large-scale, consistent, managed donor pool, genetically representing single human donor Multiple ongoing global pharma collaborations Polyclonal Antibody Development In vivo data demonstrating comparability to approved subcutaneous product and potential benefits over human-derived Robust pipeline across multiple therapeutic areas Potential to capture monoclonal, hIVIG, animal polyclonal markets and address unmet needs © 2022 SAB BIOTHERAPEUTICS, INC.
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, high-titer, high-avidity, fully-human polyclonal antibodies Generated antibodies behave similarly to human-derived with ability to specifically target Proprietary immunization strategies and robust immune response drive extremely high potency Well-established and understood regulatory path as biologic through FDA-CBER Vertical integration enabling rapid, scalable development and production of multivalent products © 2022 SAB BIOTHERAPEUTICS, INC.
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 pressure Resistance may develop as pathogen/target mutates Current cocktail trend to address resistance Polyclonal Approach Diversity of antibodies with multiple modalities Naturally selected and produced in vivo Effective against escape mutants Reduced possibility of resistance Activates cellular immunity Synergistic properties not duplicated by mono- or oligoclonals mAb TARGET Clones of a single antibody bind to a specific epitope Natural mixture of many antibodies bind to multiple epitopes Characterized Monoclonal Antibody Plasma-Derived Polyclonal Antibodies Polyclonals: Broader Spectrum Efficacy Valuable in Range of Indications 7 © 2022 SAB BIOTHERAPEUTICS, INC.
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, DEPLOYMENT OF TRANSCHROMOSOMAL BOVINE FOR PERSONALIZED ANTIMICROBIAL THERAPY, CLINICAL INFECTIOUS DISEASES, VOLUME 66, ISSUE 7, 1 APRIL 2018, PAGES 1116–1119 Open wound persisted ~7 years prior to treatment Same area following treatment with SAB -136 Demonstrated Human Safety and Efficacy in Multi-Dosing Regimen 8 © 2022 SAB BIOTHERAPEUTICS, INC.
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, Tolerability, and Pharmacokinetics of SAB-185 in Healthy Participants – Full Text View - ClinicalTrials.gov Safety, Tolerability, and Pharmacokinetics of SAB-185 in Ambulatory Participants With COVID-19 - Full Text View - ClinicalTrials.gov ACTIV-2: A Study for Outpatients With COVID-19 - Full Text View - ClinicalTrials.gov Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults – Full Text View - ClinicalTrials.gov Public Collaborations DoD, BARDA, NIH NIAID, Naval Medical Research Center, USAMRIID Filed in US and ex-US 7 Clinical Trials Span from Phase 1 to Phase 3 across 3 indications 3 INDs & 1 CTA Academic Collaborations Brigham and Women’s Hospital, Harvard, University of South Dakota, University of Pittsburgh 10 © 2022 SAB BIOTHERAPEUTICS, INC.
SELECTED PIPELINE PROGRAMS © 2022 SAB BIOTHERAPEUTICS, INC.
Robust Biologic Pipeline with Broad Polyclonal Therapeutic Reach © 2022 SAB BIOTHERAPEUTICS, INC.
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-142 Phase 1/POBA ongoing SAB-195 Phase 2 topline SAB-176 Phase 3 FPI SAB-142 Phase 1/POBA topline SAB-195 Phase 3 FPI 2023 2024 2025 2026 © 2022 SAB BIOTHERAPEUTICS, INC. FPI: First Patient In POBA: Proof of Biological Activity HV: Healthy Volunteers CDI: Clostridioides Difficile Infection T1D: Type 1 Diabetes
SAB-195: Clostridioides difficile Infections: Fast to Proof-of-Concept © 2022 SAB BIOTHERAPEUTICS, INC.
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, toxic megacolon, bowel perforation, and death. CDI infection is one of the most prevalent health care–associated bacterial infections in the US and developed world ~ 500,000 infections per year in the US1 ~ 30,000 deaths per year in the US1 CDI infection is associated with significant costs: Up to $4.8 billion each year in excess health care costs for acute care facilities alone1 Patients with the first CDI recurrence have a risk of subsequent recurrence from 25% to 40% and higher1, 2 CDI-attributable median length of stay and costs (in US$) increased from 7 (4-13) days and $13,168 ($7,525-$24,456) for patients with primary CDI only to 15 (8-25) days and $28,218 ($15,050-$47,030) for patients with recurrent CDI2 The risk of death for patients with recurrent CDI is 33% higher compared to those patients without recurrence High Unmet Medical Needs Remain References: 1. CDC. Atlanta, GA: U.S. Department of Health and Human Services. Accessed 6/27/2022 Nearly half a million Americans suffered from Clostridium difficile infections in a single year | CDC Online Newsroom | CDC 2. Economic burden of primary compared with recurrent Clostridium difficile infection in hospitalized patients: a prospective cohort study . J Hosp Infection. 2016 Jul;93(3):286-9 High Morbidity, Mortality, and Costs © 2022 SAB BIOTHERAPEUTICS, INC.
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 First-in-class fully human polyclonal antibody treatment Only treatment with dual mode of action: Unlike bezlotoxumab, SAB-195 targets surface antigen on CDI as well as multiple toxins Unlike antibiotics, SAB-195 targets several CDI toxins responsible for severity of the disease SAB-195 is a target-specific treatment targeting only CDI while fully preserving good microbiome Preclinical data supports potential for competitive efficacy as first-line polyclonal therapy for severe CDI in patients who are at high risk for CDI recurrences © 2022 SAB BIOTHERAPEUTICS, INC.
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 against CDI strain 630 or more virulent epidemic strain NAP1 Clostridium difficile chimeric toxin receptor binding domain vaccine induced protection against different strains in active and passive challenge models.. Jing-Hui Tian a, Gregory Glenn a, David Flyer a, Bin Zhou a, Ye Liu a, Eddie Sullivan b, Hua Wub, James F. Cummings a, Larry Ellingsworth a,⇑, Gale Smith https://pubmed.ncbi.nlm.nih.gov/28669616/#:~:text=Vaccine,33)%3A4079%2D4087 © 2022 SAB BIOTHERAPEUTICS, INC.
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 STUDY DESIGN Randomized, double-blind, placebo-controlled single ascending dose first-in in HVs, followed by expansion cohorts in subjects meeting high-risk for CDI recurrence criteria and in patients with CDI Study populations: = HVs for single ascending dose SAB-195 study (Phase 1) = Subjects meeting high-risk criteria: >65-years old, pharmacokinetic (PK), anti-drug antibody (ADA) immunocompromised, Phase 1 = Patients with mild-moderate CDI (Proof of Biological Activity) XXX mg/kg (determined based preclinical in vitro and in-vivo data) Randomized, double-blind, placebo-controlled Phase 2b dose-range efficacy trial with 3 dose levels of SAB-195 (high, medium, low) vs. standard of care (SOC). Followed by randomized, double-blind, placebo-controlled Phase 3 trial(s) Active comparators vary by indication: antibiotics for treatment of CDI-associated diarrhea; bezlotoxumab for reduction of CDI recurrence Study population: Patients >18 years old who are at a high risk for CDI recurrence ENDPOINTS Primary for Phase 1: acute and long-term safety Primary Proof of Biological Activity: proportion of CDI patients with clinical cure at Days 14-16 Secondary Phase 1: pharmacokinetics (PK), pharmacodynamics, anti-drug antibody (ADA), healthy microbiome impact Secondary Proof of Biological Activity: proportion of CDI patients with clinical cure at Days 30 & 60 Co-primary end points: = Treatment of CDI: proportion of patients with clinical cure at Day 14-16 (Indication 1) = Reduction of CDI recurrence: sustained clinical response rate vs standard of care (SOC) at 12 weeks (Indication 2) Secondary end points: = Safety, pharmacokinetic (PK), anti-drug antibody (ADA), microbiome impact
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.
SAB-176: First-In-Class Biologic Anti-Influenza Treatment © 2022 SAB BIOTHERAPEUTICS, INC.
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; vaccine ineffective in at-risk sub-populations No current effective treatment for seasonal influenza Current antiviral has a 48-hour window Approved antiviral small molecule treatments may shorten duration of fever and symptoms, but not effective against clinically meaningful endpoints or neuraminidase mutation; limited efficacious window 35,500,000 ILLNESSES 34,200 DEATHS 1 of 1,000 INFECTIONS RESULTED IN DEATH CDC; 2018-19 FLU SEASON © 2022 SAB BIOTHERAPEUTICS, INC.
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 First and only biologic for management of influenza in high-risk patients Adaptive and cross-reactive to multiple influenza strains Fully human polyclonal antibodies uniquely positioned to manage influenza course in high-risk patients including but not limited to: Immunocompromised Immunosenescent patients Patients in long-term care facilities Established Proof-of-Concept in the well-established validated influenza challenge model © 2022 SAB BIOTHERAPEUTICS, INC.
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 in Influenza Mouse Challenge * x Adaptive & Cross Reactive to Mutating Strains Efficacy Against Mutational Drift 22 © 2022 SAB BIOTHERAPEUTICS, INC.
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 23 Mean Total Symptom Score by Day Relative to Viral Challenge SAB-176 Achieved Statistically Significant (p = 0.013) Improvement in Symptomology at Day 4 SAB-176 not specifically targeted to pH1N1 strain used in challenge study Statistically significant reduction in virus load confirms high cross reactivity to pandemic strain (not targeted with immunogen) Reinforces ability to generate broadly neutralizing antibodies to viral variants © 2022 SAB BIOTHERAPEUTICS, INC.
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 participants 60 randomized to SAB-176 or control (30-30) Challenge strain: H1N1 California (pandemic) 300-600 participants High-risk of serious influenza with symptoms < 4 days SAB-176 and standard of care vs standard of care Dose ranging ~1,000 participants (TBD) High-risk of serious influenza with symptoms < 3-4 days SAB-176 and standard of care vs standard of care ENDPOINTS Primary: safety Secondary: pharmacokinetics, pharmacodynamics, anti-drug antibodies Primary: safety and viral load reduction Secondary: sign/symptom reduction Primary: time to onset of clinically significant influenza Reduction of risk developing influenza symptoms Primary: hospitalization and ICU days and death Secondary: multiple TIMING All participants reached end-of-study Data being analyzed for final report Readout expected mid-2021 Study start 2Q2021 Readout reported 4Q2021 Multi-site: Northern hemisphere and/or Southern hemisphere Multi-site: Northern hemisphere and/or Southern hemisphere © 2022 SAB BIOTHERAPEUTICS, INC.
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.
SAB-142: Type 1 Diabetes (T1D) Prevention © 2022 SAB BIOTHERAPEUTICS, INC.
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.
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 Type 1 Diabetes (T1D) 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 (Haller, 2019) © 2022 SAB BIOTHERAPEUTICS, INC.
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.
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-142; Grey: 5 mg/kg SAB-142 © 2022 SAB BIOTHERAPEUTICS, INC.
SAB-142: MoA Clinically Validated by 3rd Party Compound 31 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-CD3-APC RABBIT THYMO-AF488 2 Years: Low-Dose ATG* Preserved C-Peptide in New Onset T1D © 2022 SAB BIOTHERAPEUTICS, INC.
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 or anti-thymocyte globulin more likely to be a control XX participants Ascending dose SAB-142 study XXX mg/kg (preclinical NHP data will adjust) Biomarker-driven escalation with adaptive randomization based on Safety + CD4, CD8+ cells and Tregs Randomized, blinded, placebo and teplizumab controlled 90 (45:45), a control is either anti-thymocyte globulin or teplizumab SAB-142 vs anti-thymocyte globulin / teplizumab ENDPOINTS Primary: acute and long-term safety Primary Proof of Biological Activity: C-peptide Secondary: pharmacokinetics, pharmacodynamics, hypersensitivity (anti-drug antibody), C-protein, HbA1c, T regs, CD3, CD8/CD4 and other markers. New and Recent Onset T1D in Adults and Children (Study 1): Primary: improvement/control of TID disease Secondary: safety, pharmacokinetics, pharmacodynamics, hypersensitivity and serum sickness (anti-drug antibody), C-protein, HbA1c, CD3, CD8/CD4 and other markers. At Risk Adults and Children (study 2): Primary: time to onset of clinical stage (Stage 3) T1D Secondary: safety, pharmacokinetics, pharmacodynamics, hypersensitivity and serum sickness (anti-drug antibody), C-protein, HbA1c, CD3, CD8/CD4 and other markers. © 2022 SAB BIOTHERAPEUTICS, INC.
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 2026 © 2022 SAB BIOTHERAPEUTICS, INC.
Summary 34 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 indications. SAB-195: Preclinical data supports potential for competitive efficacy as first-line polyclonal antibody therapy for severe CDI in patients who are at a high risk for recurrences, expect to file IND in H2 2023-H1 2024. SAB-176: First-in-class fully-human polyclonal antibody treatment aimed to provide superior efficacy for prophylaxis and management of influenza in patients at high-risk, planned initiation of Phase 2b trial in 2H 2023. SAB-142: First-in-class fully-human polyclonal antibody treatment aimed to provide superior efficacy for delaying onset of clinical Stage 3 Type 1 Diabetes, IND submission expected in 2024. © 2022 SAB BIOTHERAPEUTICS, INC.
APPENDIX © 2022 SAB BIOTHERAPEUTICS, INC.
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 by Novel Proprietary Platform 36 $200M awarded for rapid & pandemic response Advancement of programs from preclinical into Phase 3 clinical development in the respiratory therapeutic area RAPID PROOF-OF-CONCEPT (90 days to cGMP) NATURAL HUMAN ANTIBODIES (without human donors or serum) MULTI-VALENT CAPABILITIES (by nature, & by design–multiple targets in one product) TARGET AGNOSTIC (virus, bacteria, toxin, allergen) SCALABLE, REPLICABLE, CONSISTENT PRODUCTION Demonstrated clinical safety and efficacy Proof-of-platform with highly-mutating infectious disease Robust pipeline with broad therapeutic reach Demonstrated in vivo efficacy to >12 targets Multiple ongoing collaborations with global pharma Opportunities in monoclonal discovery, human immune globulins and therapeutic innovation Opportunity to Create New Class of Immunotherapies DiversitAb Platform © 2022 SAB BIOTHERAPEUTICS, INC.
Intellectual Property 11 © 2022 SAB BIOTHERAPEUTICS, INC.
Scaled Infrastructure & Capacity: Tc Bovine & Plasma Production Facility 38 © 2022 SAB BIOTHERAPEUTICS, INC.
Scaled Infrastructure & Capacity: Laboratory & Manufacturing Manufacturing Facility (200L) Manufacturing Facility (50L) 39 CET Lab Labeling Suite Fill Suite Cell Culture Lab 50L Suite © 2022 SAB BIOTHERAPEUTICS, INC.
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EXHIBIT 99.2 |
SAB Biotherapeutics to Present New Data at ISIRV OPTIONS XI Conference
on SAB-176 Phase 2a Influenza Trial and SAB-185’s Effectiveness
Against Multiple COVID-19 Variants
SIOUX FALLS, S.D., Sept. 23, 2022 (GLOBE NEWSWIRE) – SAB Biotherapeutics (Nasdaq: SABS), ("SAB”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, announced today that the Company will present new data on its fully-human polyclonal antibody platform’s ability to maintain its efficacy against multiple variants of several highly mutating viruses at the Options for Control of Influenza (OPTIONS XI) conference, which is hosted by the International Society for Influenza and other Respiratory Virus Diseases (ISIRV) in Belfast, Northern Ireland, from Sept. 26-29, 2022.
SAB will conduct an oral presentation, titled “Efficacy and Safety of SAB-176, a Novel Anti-Type A and B Influenza Immunotherapeutic: A Phase 2a, Randomized, Double-Blind Trial in H1N1 Challenged Adults,” on Thursday, Sept. 29, at 11: 24 AM BST.
Additionally, SAB will present a poster, titled “Transchromosomic Bovine-Derived Human Anti-SARS-CoV-2 Polyclonal Antibodies Protect hACE2 Transgenic Syrian Hamsters Against Multiple SARS CoV-2 Variants,” on Tuesday, Sept. 27, from 5:30-7 PM BST.
“We look forward to highlighting the power of polyclonal antibodies to neutralize highly mutating viruses and the differentiation of SAB’s novel therapeutic products at the upcoming ISIRV conference,” said Eddie Sullivan, co-founder, President, and Chief Executive Officer of SAB.
To view the OPTIONS XI program online, please visit: https://www.optionsxi2022.org.uk/programme.
About SAB Biotherapeutics, Inc.
SAB Biotherapeutics, Inc. (SAB) We are a clinical-stage biopharmaceutical company focused on the development of powerful and proprietary immunotherapeutic polyclonal human antibodies to treat and prevent infectious diseases and immune and autoimmune disorders. Our development programs include infectious diseases resulting from outbreaks and pandemics, as well as immunological, gastroenterological, and respiratory diseases that have significant mortality and health impacts on immune compromised patients. SAB has applied advanced genetic engineering and antibody science to develop transchromosomic (Tc) Bovine™. Our versatile DiversitAb™ platform is applicable to a wide range of serious unmet needs in human diseases. It produces natural, specifically targeted, high-potency, fully-human polyclonal immunotherapies without the need for human donors. SAB currently has multiple drug development programs underway and collaborations with the US government and global pharmaceutical companies. For more information on SAB, visit: https://www.SAb.bio/ and follow SAB on Twitter and LinkedIn.
Forward-Looking Statements
Certain statements made herein that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995.
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Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including the development and efficacy of our influenza program, C. diff. program, Type 1 Diabetes program, and other discovery programs, the likelihood that a patent will issue from any patent application, the results, including timing, of the development of SAB-195 (including any IND filing or proposed clinical trials), financial projections and future financial and operating results (including estimated cost savings and cash runway), the outcome of and potential future government and other third-party collaborations or funded programs (including negotiations with the DoD). These statements are based on the current expectations of SAB and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/ Except as otherwise required by law, SAB disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
CONTACTS:
Investor Relations:
SABIR@westwicke.com
Media Relations:
SABPR@westwicke.com