8-K
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 01, 2022

 

 

SAB BIOTHERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-39871

85-3899721

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

2100 East 54th Street North

 

Sioux Falls, South Dakota

 

57104

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 605 679-6980

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common stock, $0.0001 par value per share

 

SABS

 

The NASDAQ Stock Market LLC

Warrants, each exercisable for one share of Common Stock at an exercise price of $11.50 per share

 

SABSW

 

The NASDAQ Stock Market LLC

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 November 01, 2022, SAB Biotherapeutics, Inc. (the “Company” or “SAB”) led two PowerPoint presentations titled, “Plasma fractionation and downstream processing of human polyclonal antibodies from the DiversitAb platform” and “Phase 2 efficacy and safety of two novel SAB immunotherapies against respiratory disease indications associated with highly mutating viruses” at the 2022 Plasma Product Biotechnology Conference held in in Limassol, Cyprus.

The Company's first presentation provided an overview of SAB’s novel immunotherapy platform utilizing a specialized manufacturing process to enable a scalable and reliable production of targeted, higher-potency neutralizing antibody products than has been previously possible. A copy of the first presentation is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.

The Company's second presentation provided data on SAB-185 for COVID-19 and SAB-176 for seasonal and pandemic influenza. The data show that SAB-185 and SAB-176 are highly effective against variants of several highly mutating viruses associated with the diseases, a major challenge in currently available treatments for COVID-19 and influenza. A copy of the second presentation is furnished herewith as Exhibit 99.2 and is incorporated herein by reference.

The foregoing (including Exhibit 99.1 and 99.2) is being furnished pursuant to Item 7.01 of Form 8-K 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 each 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-176, SAB-185, and 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 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 November 3, 2022, the Company issued a press release announcing that the Company presented an overview of its DiversitAb™ polyclonal platform and data on SAB-176 and SAB-185 showing the benefits of fully-human polyclonal antibodies derived from SAB’s Transchromosomic ("Tc") Bovine™ over plasma derived antibodies from humans, at the 2022 Plasma Product Biotechnology Conference in Limassol, Cyprus, which concluded on November 03, 2022.

A copy of the press release is attached as Exhibit 99.3 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.

Exhibit Number

 

Description

99.1

 

Presentation titled, “Plasma fractionation and downstream processing of human polyclonal antibodies from the DiversitAb platform.”

99.2

 

Presentation titled, "Phase 2 efficacy and safety of two novel SAB immunotherapies against respiratory disease indications associated with highly mutating viruses."

99.3

 

Press Release of the Company, dated November 3, 2022.

104

 

Cover Page Interactive Data File-the cover page XBRL tags are embedded within the Inline XBRL document.

 

 

 


 

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.

 

 

 

SAB Biotherapeutics, Inc.

 

 

 

 

Date:

November 07, 2022

By:

/s/ Eddie J. Sullivan

 

 

 

Eddie J. Sullivan
Chief Executive Officer

 

 


Slide 1

Plasma Fractionation and Downstream Processing of Human Polyclonal Antibodies from the DiversitAb Platform © 2022 SAB BIOTHERAPEUTICS, INC. Plasma Product Biotechnology Conference  2022 Christoph Bausch, PhD, Chief Operating Officer EXHIBIT 99.1


Slide 2

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. 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. 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.   Unless otherwise specified, information is current at the date hereof, unless specifically noted. © 2022 SAB BIOTHERAPEUTICS, INC.


Slide 3

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 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.


Slide 4

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 Ability to target human antigens Natural mixture of many human antibodies that bind to multiple epitopes Plasma-Derived Polyclonal Antibodies SAB Polyclonal Antibodies: Next Generation of Biologics 4 © 2022 SAB BIOTHERAPEUTICS, INC. TARGET FDA: CENTER FOR BIOLOGICS EVALUATION & RESEARCH (CBER)


Slide 5

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 chromsomes.  HAC present in the Tc Bovine allows for the highest production of human antibody repertoire most similar to humans. Tc Bovine A Natural Way to Produce Human Polyclonal Antibodies Tc Bovine™ contain all the human immunoglobulin genes Human artificial chromosome (HAC) ~17Mb contains the entire unarranged VDJ human immunoglobulin loci (IgH + Igκ) © 2022 SAB BIOTHERAPEUTICS, INC.


Slide 6

Human Antibody Production in Bovine B-Cell bIg Bovine chromosomes X X Bovine DNA-binding proteins Tc Bovine B-cells Remove species-incompatibility in protein-protein interaction Remove species-incompatibility in protein-DNA interaction HAC mRNA mRNA Human Bovine Chimeric IgM on B-Cell Receptor Fully-human IgG >90% IgG1 subclass © 2022 SAB BIOTHERAPEUTICS, INC.


Slide 7

B-Cells Produce Anti-Target Fully-Human Polyclonal Antibodies Hyperimmunization Multiple immunizations drive titers to extremely high levels with exceptional avidity maturation and potency B-Cells Produce Human Antibodies Natural and somatic mutation drives very high-level B-cell clone avidity maturation in Tc Bovine Therapeutic Diverse mixture of anti-Target human polyclonal antibodies allowing production of a fully-human immunoglobulin (hIgG) Rich diversity of IgG antibodies to Spike protein epitopes Fc binding to FcR ligands allows effector cell recruitment & activates complement Transferred full germline repertoire of human antibody response 7 Antigen © 2022 SAB BIOTHERAPEUTICS, INC.


Slide 8

First of its Kind 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.


Slide 9

Upstream Antibody Production ANIMAL 1 V3 V4 V5+ D8 D11 D14 D8 D11 D14 D8 D11 D14 POOLED PLASMA PLASMA COLLECTIONS TITERS V1 V2 V3 V4 V5 V1 V2 V3 V4 V5 Procedures for Heterogeneity and Consistent Neutralizing Titers ANIMAL 2 V3 V4 V5+ D8 D11 D14 D8 D11 D14 D8 D11 D14 PLASMA COLLECTIONS 9 © 2022 SAB BIOTHERAPEUTICS, INC. Continue Vaccinations & Collections Tc Bovine™ Vaccination WEEK Vaccinate Every Three Weeks, One Animal = 30L Plasma/month 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 V4 V3 V2 V1 V5 TITERS


Slide 10

Downstream Manufacturing Process Plasma selected to potency and impurity specifications Plasma thawed then pooled Caprylic Acid Fractionation & Clarification Chromatography Caprylic Acid: Precipitates bovine plasma proteins and HCP proteins pH adjustment Filter Aid – adheres insoluble proteins Depth Filtration: Clarifies Effective Viral Clearance Step Neutralize and 0.22 filter Chromatography steps include two affinity and one ion exchange Positive Selection: Captures human light chain Low pH hold for viral inactivation Negative Selection: Captures bovine heavy chain TFF: Prepare for Anion Exchange Anion Exchange: Anion Exchange used for polishing Nanofiltration & Final Formulation 0.22um Filtered DS Bulk Labeling & Distribution Nanofiltration: Dedicated Viral Clearance Step Final Formulation: Concentrated and diafiltrated with Formulation Buffer Sterile filtered into bulk drug substance Vials are labeled and boxed Approved Released Fill/finish DP Bulk DS sterile filtered and filled into 10R glass vials. Stoppered and capped. Tested and released. 10 Plasma Selection & Pooling © 2022 SAB BIOTHERAPEUTICS, INC.


Slide 11

Manufacturing Step Process Overview SUITE 2 Chromatography/UF/Nanofiltration SUITE 1 Plasma Thaw / Pooling / Fractionation SUITE 3 Post Viral TFF SUITE 4 Fill/Finish © 2022 SAB BIOTHERAPEUTICS, INC.


Slide 12

Scaled Infrastructure & Capacity: Laboratory & Manufacturing Manufacturing Facility (200L) Manufacturing Facility  (50L) 12 CET Lab Labeling Suite Fill Suite Cell Culture Lab 50L Suite © 2022 SAB BIOTHERAPEUTICS, INC.


Slide 13

Scaled Infrastructure & Capacity: Tc Bovine & Plasma Production Facility 13


Slide 14

B/Florida/04/2006 Challenge strain SOURCE: NEXTFLU AT HTTPS://NEXTFLU.ORG/VIC/12Y/ Antibodies produced to B/Phuket/3073/2013– like virus 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 14 © 2022 SAB BIOTHERAPEUTICS, INC.


Slide 15

H1N1 H3N2 B-Vic B Yam Sample Started  at 5mg/ml A/California/ 4/2009 (Pandemic Strain) A/Michigan/ 45/2015 A/Brisbane/02/2018 A/Guangdong-maonan/2019 A/Singapore/INIFMH-16-0019/2016 A/Kansas/14/2017 A/Hong Kong/45/2019  B/Maryland /15/2016 B/Colorado/ 06/2017 B/Washington/02/2019  B/Phuket/ 3073/2013 B/California/ 12/2015 Anti-Influenza (Tc Bovine-derived quadrivalent hyperimmune) SAB-176  1:1,024 1:512 1:512 1:512 1:512 1:512 1:256 1:256 1:256 1:128 1:256 1:128 32X 16X 16-32X 16-32X 8-32X 16-128X 16-32X 16-32X 16-32X 16-32X 32X 16-32X Anti-Influenza hIVIG (human-derived) 2018 1:32 1:32 1:32 1:32 1:64 1:32 1:16 1:16 1:16 1:8 1:8 1:8 2017 1:32 1:32 1:16 1:16 1:64 1:32 1:16 1:16 1:16 1:8 1:8 1:8 2013 1:32 1:32 1:32 1:16 1:16 1:4 1:8 1:8 1:8 1:4 1:8 1:4 Negative Control Antibody NC Ab  <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 18-21 18-19 19-20 20-21 Vaccine strain (season): SAB-176 protects against seasonal and pandemic influenza vaccine strains  past & future non-vaccine strains Highly-Potent: Exceeds Titers of Human Hyperimmune IVIG by up to 128X SAB-176 purified from TcB plasma vaccinated with 18-21 vaccine strain HUBER LAB, USD, JUL 2021   © 2022 SAB BIOTHERAPEUTICS, INC.


Slide 16

High Avidity: Driven By Hyperimmunization SURENDER LAB; DIVISION OF VIRAL PRODUCTS, CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER) FDA 05 APR 2021 JOURNAL OF INFECTIOUS DISEASE (2022) SEP 4;226(4):655-663 SAB-185 (Anti-SARS-CoV2) avidity increases with affinity maturation driven by hyperimmunization TITERS V1 V2 V3 V4 V5 Tc Bovine™ Vaccination WEEK V3 D7-14 High Volume Plasma Collection V4 V3 V5 V4 D7-14 V5 D7-14 © 2022 SAB BIOTHERAPEUTICS, INC.


Slide 17

High Avidity More Closely Linked to Patient Outcomes than Neutralizing Titers Neutralization Titers Demonstrate Discordance to Disease Severity & Outcome High Avidity Shows Direct Correlation to Patient Survival Neutralizing antibody titers and hACE2 receptor inhibition activity of COVID-19 patients’ plasma during hospitalization SURENDER LAB; DIVISION OF VIRAL PRODUCTS, CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER) FDA; NATURE COMMUNICATIONS (2021) 12:1221 © 2022 SAB BIOTHERAPEUTICS, INC.


Slide 18

Oncology SAB-162E (Human Anti-Human EGFR pAbs) Exhibits High Binding Capability 18 ELISA EGFR ELISA EGFRvIII H292 H1975 H1299 © 2022 SAB BIOTHERAPEUTICS, INC. C


Slide 19

SAB-162E has Functional Properties for Addressing the Complexity of Cancer 19 SAB-162E inhibits cellular migration of NSCLC cells SAB-162E activates ADCC effector function © 2022 SAB BIOTHERAPEUTICS, INC. SAB-162E activates CDC effector function A B C


Slide 20

in vivo Efficacy Study for SAB-162E (NOD/SCID mice)​ p=0.0004 p=0.0008 p=0.0016 * * * © 2022 SAB BIOTHERAPEUTICS, INC.


Slide 21

Consistent, Replicable Platform In Vivo Efficacy Demonstrated Across a Broad Range Targets TARGET EFFICACY MODEL(S) COLLABORATORS Anthrax 100% mouse (lethal) Food and Drug Administration Alphaviruses 100% 100% mouse (lethal aerosol) non-human primate (viral clearance) Naval Medical Research Center, University of Pittsburgh, NIH: National Institute of Allergy and Infectious Diseases Clostridioides Difficile  100% 87%  hamster (lethal) mouse (lethal) Novavax Dengue 100% non-human primate (viral clearance) Naval Medical Research Center Ebola 90% 100% mouse (lethal) non-human primate (lethal) Naval Medical Research Center, NIH: National Institute of Allergy and Infectious Diseases, Novavax Hantavirus 80-100% 100% hamster (lethal) non-human primate (viral clearance) United States Army Medical Research Institute of Infectious Diseases Influenza 100% 100% mouse (lethal) mouse (lethal aerosol) National Institutes of Health, University of South Dakota, Utah State University, Naval Medical Research Center Plague 100% Mouse (lethal aerosolized) United States Army Medical Research Institute of Infectious Diseases MERS-CoV 100% mouse (viral clearance) Biomedical Advanced Research and Development Authority, Naval Medical Research Center, NIH: National Institute of Allergy and Infectious Diseases, Novavax SARS-CoV2 100% hACE2 hamster (lethal) Biomedical Advanced Research and Development Authority, Naval Medical Research Center, University of Pittsburgh Zika 100% 100% 100% mouse (lethal) hamster (lethal) non-human primate (viral clearance) Public Health Agency of Canada, Utah State University Harvard University  21 © 2022 SAB BIOTHERAPEUTICS, INC.


Slide 22

Tc Goats™ - Expanding The Human Immunotherapeutic Platform for Personalized Medicine


Slide 23

Genetic Engineering Science Applied Across Multiple Species SAB Capra, LLC. is a wholly-owned subsidiary of SAB Biotherapeutics, Inc. Advancing novel antibody production platform leveraging transgenic goats Functionality of the HAC proven in a second species (ruminant ungulate) Generated H7N9-specific human polyclonal antibodies from Tc Goat (caprine) platform. Scientific Reports, 2019 SAB Capra Phase 2 STTR Grant (NIH/NIAID): in collaboration with Utah State University Total funding $1,501,157 ($926,194 to SABC, $574,963 to USU) Two years: 18 Apr 2019 – 31 Mar 2021 Two times of 12-month no cost extension granted—new end date 31 Mar 2023  Genetic optimization in our Tc Bovine was done in 10 years while the goat optimization was done in 2 years. 23 © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL


Slide 24

Demonstrated Fully Human IgG in Tc Goat 24 Human IgG in Tc Capra Kids © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL


Slide 25

Advancing the Tc Platform for Continued Advancement of Human Health Developing targeted human polyclonal antibodies for use in personalized medicine Tc Goat platform production ready for producing diagnostics and testing reagent applications. Accommodating smaller volume markets, lower cost of development and maintenance, and accelerated scaling (shorter gestation, multiple births)  25 © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL


Slide 26

DiversitAb™ Proprietary Platform Technology © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL


Slide 27

Tc Bovine™ Vaccination Plasma Collection WEEK V1 V2 V3 V4 V5 PRIME–pDNA BOOST–RECOMBINANT PROTEIN V6 HUMAN POLYCLONAL ANTIBODIES TARGET 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 D8 D14 D11 D8 D14 D11 Pooling and Manufacturing D8 D14 D11 DiversitAb™ Development Process for Rapid High Titer & Avidity Maturation CONTINUE VACCINATIONS & COLLECTIONS Purified human  immunoglobulin G (hIgG) designed to specifically bind to target © 2021 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL 27


Slide 28

SAB-185: Specifically Targeted Human Immune Response Spike Glycoprotein Diversity of antibodies and uniquely combinatorial paratopes drives effector functions including antibody and complement dependent cellular cytotoxicity Multiple blocking and neutralizing antibody species bind to single epitope Multiple blocking and neutralizing antibodies with uniquely determined and multifactorial paratopes bind to single multi-conformational antigen epitope D Spike Glycoprotein Receptor binding domain in S1 spike protein binds to ACE-2 receptor on human cells; then undergoes a conformational change to allow the S2 spike protein domain to fuse with the cellular membrane leading to infection of the cell SAB-185 Polyclonal Spike Protein MOA Antibodies bind multiple conformations of SARS-CoV-2 extracellular spike protein epitope and appears to prevent most all conformations of the infectious determinant spike protein from interacting with ACE-2 receptors on host cells, allowing effector cells to phagocytize virus and eliminate/lyse infected cells via complement MOA of Novel Polyclonal Antibody Raised Against SARS-CoV-2 Spike Protein 28 © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL


Slide 29

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 Confirms Feasibility of Multi-dosing Open wound persisted ~7 years prior to treatment Same area following treatment with SAB -136 Positioned for Personalized Medicine 29 © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL


Slide 30

Highly-Potent: Exceeds Titers of Human Convalescent Plasma by 40X WILLIAM B. KLIMSTRA. PH.D. DEPARTMENT OF IMMUNOLOGY ; MEMBER, CENTER FOR VACCINE RESEARCH; THE UNIVERSITY OF PITTSBURGH 160 <20 6400 40X HIGHER NEUTRALIZING TITERS HYPERIMMUNIZATION WITH WUHAN SPIKE PROTEIN 30 © 2021 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL


Slide 31

© 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL High Potency and Broad Cross Protective Neutralization Dr. Victor Huber, University of South Dakota


Slide 32

One of Its Kind DiversitAb™ Platform © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL


Slide 33

Manufacturing Process hIgG purification overview Plasma Request & Pooling Caprylic Acid Fractionation Kappa Select Capture Affinity HC15 (Neg Affinity) Q-Seph (Polish) Captures BIgG HC molecules and enriches for hIgG Captures Kappa IgG (Reduces cIgG and bIgG impurities) Polishes and reduces IgA, IgM host cell proteins, DNA, and endotoxin Precipitates bovine plasma proteins and HCP. Viral & Pathogen Reduction Plasma thawed and pooled to titer and impurity specifications t-bIgG cIgG Fully hIgG t-bIgG cIgG Fully hIgG t-bIgG cIgG Fully hIgG t-bIgG Fully hIgG Fully hIgG Bovine Plasma Proteins Bovine Plasma Proteins


Slide 34

Downstream Manufacturing Process Vials labeled and boxed after QC tested, QA approves labels and then releases prior to distribution. Nanofiltration Dedicated Viral Clearance Step Final Formulation Concentrated and diafiltrated with Formulation Buffer Chromatography steps include two affinity and one ion exchange Caprylic Acid: Precipitates proteins pH adjustment Add Filter Aid – adheres insoluble proteins Depth Filtration: Clarification Effective Viral Clearance Step Neutralize and 0.22 filter KappaSelect: Captures human light chain Perform low pH hold for viral inactivation HC15: Captures bovine heavy chain TFF step to prepare sample for Q Sepharose Q Sepharose: Anion Exchange used for polishing 0.22 Filter Sterile filtered into bulk drug substance Final Fill Bulk drug substance filtered and filled into 10R glass vials. Stoppered and capped. Tested and released. Plasma Request & Pooling 1 Caprylic Acid Fractionation 2 Chromatography 3 Nanofiltration & Final Formulation 4 0.22 Filtration & Final Fill 5 Labeling & Distribution 6 Plasma selection strategy; thawed for 24-72 hours, then combined SAB Biotherapeutics – CONFIDENTIAL


Slide 35

Downstream Manufacturing Process Vials labeled and boxed prior to being approved and released Labels are created by Nanofiltration Dedicated Viral Reduction Step Final Formulation Concentrated and diafiltrated with Formulation Buffer Chromatography steps include two affinity and one ion exchange Caprylic Acid: pH adjustment, Add Filter Aid Depth Filtration: Effective Viral Clearance Step Neutralize and 0.22 filter KappaSelect: Captures human light chain Perform low pH Viral inactivation HC15: Captures bovine heavy chain Q Sepharose: Anion Exchange used for polishing 0.22 Filter Sterile filtered Final Fill Perform terminal filter step prior to fill Fill using Flexicon pump. Filling and stoppering occur in ISO 5 Hood Seals are applied in ISO 7 area of Room 4 Plasma Request & Pooling 1 Caprylic Acid Fractionation 2 Chromatography 3 Nanofiltration & Final Formulation 4 0.22 Filtration & Final Fill 5 Labeling & Distribution 6 Pooling strategy finalized; plasma requested from QA, then thawed for 24-72 hours, then pooled CONFIDENTIAL


Slide 36

SAB-162E decreased mouse in vivo tumor growth and almost tripled survival time 36 © 2022 SAB BIOTHERAPEUTICS, INC.

Slide 1

© 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL Plasma Product Biotechnology Conference  2022 Christoph Bausch, PhD, Chief Operating Officer Phase 2 Efficacy and Safety of Two Novel  SAB Immunotherapies Against Respiratory Disease  Indications Associated with ​Highly Mutating Viruses​ ​ SAB-185: A SARS-CoV-2 Immunotherapeutic​ SAB-176: A Pan Influenza Immunotherapeutic EXHIBIT 99.2


Slide 2

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. 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. 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.   Unless otherwise specified, information is current at the date hereof, unless specifically noted. © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL


Slide 3

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 3 © 2022 SAB BIOTHERAPEUTICS, INC.


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Robust Biologic Pipeline with Broad Polyclonal Therapeutic Reach © 2022 SAB BIOTHERAPEUTICS, INC.


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SAB-185 Anti-SARS-CoV2


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6 © 2022 SAB BIOTHERAPEUTICS, INC. DiversitAb™ Rapid Discovery and Development Process for SAB-185 Program Start Discovery & Initial Antibody Production Clinical Development Initial plasma collections Initial Antigen Development & Production (04Mar2020) Initial Manufacturing Began (25May2020) TcB Immunizations (31Mar2020) IND Filed (06Jul2020) Phase 1 FSI in HV (10AUG2020) Phase 2b FPI 3 Arm (Low & High Dose) PBO controlled (04APR2021) Phase 3 FPI (29SEP2021) Phase 1b FPI in COVID19 Patients (18AUG2020) Jan 2021 – Dec 2021 Apr 2020 – Dec 2020 Mar 2020 Non-clinical Studies Began (02Jun2020) Project Start to IND Filing <125 Days, and First Subject In <160 Days Project Start to Ph 3 <2 Years


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SAB-185 Neutralization Potential vs. the Munich Variant (Spike D614G) and Other Variants © 2022 SAB BIOTHERAPEUTICS, INC. 7


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SAB-185 Protects Recombinant hACE2 Hamsters from Mortality and/or Severe Morbidity from SARS CoV-2 Variants Including Omicron © 2022 SAB BIOTHERAPEUTICS, INC. 8 SAB-185 protection from mortality in hamsters challenged with six variant SARS CoV-2 isolates SAB-185 protection from weight loss in hamsters challenged with six variant SARS CoV-2 isolates SAB-185 protection from Weight Loss in hamsters challenged with Omicron variant SA


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Addresses Escape Mutants: SAB-185 Superior to Monoclonal Antibody 9 WASHINGTON UNIVERSITY SCHOOL OF MEDICINE–ST. LOUIS; 15 JAN 2021 Escape Mutants No Escape Mutants SAB-185 Targeted High-Potency Polyclonal Mixture Monoclonal Ab LOT 1 LOT 5 LOT 6 No Antibody 2H04 E484K E484A F486S © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL Selection for VSV-SARS-CoV-2 Wild Type Escape Mutation


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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 ANALYSIS Interim Analysis   LOW-DOSE (3,840 UNITS/KG) HIGH-DOSE (10,240 UNITS/KG) Difference from PBO for RNA level (log10 copies/ml) 1.48 0.67 Minimum RNA level difference (log10 copies/ml) 0.5 0.5 Minimum Posterior Probability 0.6* 0.6* Actual Posterior Probability 0.91 0.75 Viral load reductions of ≥0.5 log10 for both lower and higher dose at Day 3 Sub-analysis** of viral load reduction shows pronounced impact in small subset of high-risk patients given either lower or higher dose NIH NIAID (ACTIV) IN COLLABORATION WITH THE AIDS CLINICAL TRIALS GROUP (ACTG) ** Results shown are not statistically significant Low Risk / Low Dose Low Risk / High Dose High Risk / Low Dose High Risk / High Dose 10 © 2022 SAB BIOTHERAPEUTICS, INC.


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SAB-176 Pan Influenza Therapeutic


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Targeted Product Profile and Administration Routes 12 © 2022 SAB BIOTHERAPEUTICS, INC. Treat high-risk influenza adult patients prior to the development of severe disease: Adults 65 years of age and older Immunocompromised due to a disease or medications (autoimmune, cancer, etc.) Patients with respiratory, cardiovascular, kidney, metabolic, neurological disorders Pre- and post-exposure prophylaxis of high-risk patients and critical services personnel High-risk patients in nursing homes/assisted living Hospitalized First responders/military/medical providers Critical infrastructure operators Administration Routes Intravenous Subcutaneous and Intramuscular administration in development


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B/Florida/04/2006 Challenge strain SOURCE: NEXTFLU AT HTTPS://NEXTFLU.ORG/VIC/12Y/ Antibodies produced to B/Phuket/3073/2013 –like virus 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 13 © 2022 SAB BIOTHERAPEUTICS, INC. – CONFIDENTIAL


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H1N1 H3N2 B-Vic B Yam Sample Started  at 5mg/ml A/California/ 4/2009 (Pandemic Strain) A/Michigan/ 45/2015 A/Brisbane/02/2018 A/Guangdong-maonan/2019 A/Singapore/INIFMH-16-0019/2016 A/Kansas/14/2017 A/Hong Kong/45/2019  B/Maryland /15/2016 B/Colorado/ 06/2017 B/Washington/02/2019  B/Phuket/ 3073/2013 B/California/ 12/2015 Anti-Influenza (Tc Bovine-derived quadrivalent hyperimmune) SAB-176  1:1,024 1:512 1:512 1:512 1:512 1:512 1:256 1:256 1:256 1:128 1:256 1:128 32X 16X 16-32X 16-32X 8-32X 16-128X 16-32X 16-32X 16-32X 16-32X 32X 16-32X Anti-Influenza hIVIG (human-derived) 2018 1:32 1:32 1:32 1:32 1:64 1:32 1:16 1:16 1:16 1:8 1:8 1:8 2017 1:32 1:32 1:16 1:16 1:64 1:32 1:16 1:16 1:16 1:8 1:8 1:8 2013 1:32 1:32 1:32 1:16 1:16 1:4 1:8 1:8 1:8 1:4 1:8 1:4 Negative Control Antibody NC Ab  <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 <1 18-21 18-19 19-20 20-21 Vaccine strain (season): SAB-176 protects against seasonal and pandemic influenza vaccine strains  past & future non-vaccine strains Highly-Potent: Exceeds Titers of Human Hyperimmune IVIG by up to 128X SAB-176 purified from TcB plasma vaccinated with 18-21 vaccine strain HUBER LAB, USD, JUL 2021   © 2022 SAB BIOTHERAPEUTICS, INC.


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Trial Design and Methods 15 © 2022 SAB BIOTHERAPEUTICS, INC. Trial design: Randomized, Double-Blind, Placebo-Controlled Influenza Challenge Study Study sample size:  60 Healthy volunteers, 18-45 years of age Study flow: Participants were admitted into the hVIVO facility 2 days prior inoculation and were quarantined for up to 11 days (Day -2 to 8) with Influenza challenge occurring on day 0 and SAB-176/placebo infusion on day 1. Participants were discharged on day 8. Participants returned for 1 outpatient visit on day 28.  Subjects were randomized 1:1 prior to receive SAB-176 or matching placebo 20-24 hours after influenza challenge.  Challenge virus: A previously utilized Influenza pandemic H1N1 A/California/2009-like challenge virus was produced by Meridian Life Sciences under Good Manufacturing Practices (Watson et al., 2015; Leibowitz et al., 2020) Investigational treatment: Participants received 25 mg/kg of SAB-176 diluted in normal saline at a concentration of 20 mg/ml or an equivalent volume of normal saline (placebo) in a single IV infusion.  EudraCT # 2021-001254-56  ClinicalTrials.gov number NCT04850898


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Primary and Selected Secondary Outcome Measures 16 © 2022 SAB BIOTHERAPEUTICS, INC. Primary Outcome Measure: Area under the viral load-time curve (VL-AUC) of Influenza A/California/2009 H1N1 virus as determined by qRT-PCR on nasal samples of SAB-176 when compared to placebo. [Time Frame: 8 Days ] Selected Secondary Outcome Measures: Area under the curve over time of total clinical symptoms score (TSS-AUC) as measured by graded symptom scoring system (categorical and visual analogue scales) to evaluate the effect of SAB-176 in reducing symptoms due to Influenza A/California/2009 H1N1 virus compared to placebo. [Time Frame: 8 Days ] Duration of influenza quantifiable by cell culture measurement to evaluate the effect of SAB-176 in reducing viral loads in cell culture due to Influenza A/California/2009 H1N1 virus, compared to placebo. Safety


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Emerging Safety Profile 17 © 2022 SAB BIOTHERAPEUTICS, INC. Overall, the challenge virus inoculation and subsequent single IV infusion of SAB-176 were safe and well tolerated. There were no SAEs in this study, no AEs leading to early withdrawal from the study, and none of the AEs were of grade 3 or higher in severity. The incidence of AEs was similar between the treatment groups: 18 (60.0%) participants in the SAB‑176 group reported 27 AEs and 16 (53.3%) participants in the placebo group reported 23 AEs from viral challenge (Day 0) onwards. Most TEAEs were reported in the SOC general disorders and administration site conditions (8 TEAEs in 5 [16.7%] participants in the SAB-176 group, and 1 TEAE in 1 [3.3%] participant in the placebo group). Almost all TEAEs were mild in intensity. One TEAE of neutrophil count decreased in the SAB-176 group and 4 TEAEs (ALT increased [n=1], lymphocyte count decreased [n=2], and rash [n=1]) in the placebo group were moderate in intensity. TEAEs that were at least possibly related to the study treatment were reported by 2 (6.7%) participants in the SAB‑176 group (1 TEAE of blood pressure systolic decreased and 1 TEAE of paraesthesia) and by 4 (13.3%) participants in the placebo group (1 TEAE of rhinorrhoea, 1 TEAE of ALT increased, 1 TEAE of pain in extremity, and 1 TEAE of procedural hypotension).


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SAB-176 Met the Primary Endpoint of Viral Load and Secondary Endpoint of Symptom Reduction Achieved Statistically Significant (p = 0.026) Reduction in Viral Load Mean Viral Load by Nasal Samples qRT-qPCR by Day Relative to Viral Challenge 18 Mean Total Symptom Score by Day Relative to Viral Challenge SAB-176 Achieved Statistically Significant (p = 0.013) Improvement in Symptomology at Day 4 © 2022 SAB BIOTHERAPEUTICS, INC.


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19 © 2022 SAB BIOTHERAPEUTICS, INC. Kaplan-Meier Time to Resolution of Positive Viral Cultures Following First Positive Culture Starting 2 Days After Intranasal Viral Challenge Shortened time of viral shedding, as measured by lack of culturable virus


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20 © 2022 SAB BIOTHERAPEUTICS, INC. Conclusions SAB-176: A novel pan influenza polyclonal immunotherapeutic Demonstrates significant HAI titers to multiple Type A and B and pandemic influenza strains In response to pandemic H1N1 viral challenge met primary endpoint of reducing nasopharyngeal viral load as determined by qRT-PCR Met secondary endpoint of reducing symptoms Shortened the time of infectious viral shedding, as measured by inability to culture virus in vitro IV infusion of SAB‑176 appeared to be safe and well tolerated. The incidence of AEs was similar between SAB-176 and placebo. Next step is conducting a Phase 2b dose-range finding study in influenza patients at high risk of developing severe influenza complications

EX-99.3

 

https://cdn.kscope.io/976a5fc277b7bd4c69fdc8202ec2d757-img3718120_0.jpg 

EXHIBIT 99.3

 

SAB Biotherapeutics Presents Overview of DiversitAb Platform and Data Showing Benefits of Fully-Human Polyclonal Antibodies Derived from Cows vs. Human-Derived Plasma, at 2022 Plasma Product Biotechnology Conference

 

SAB highlights data on SAB-176 for seasonal and pandemic influenza and SAB-185 for COVID-19, showing broad efficacy against highly mutating viruses associated with respiratory disease

 

SIOUX FALLS, S.D., November 3, 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, today announced that the Company presented an overview of its DiversitAb polyclonal platform and data on SAB-176 and SAB-185 showing the benefits of fully-human polyclonal antibodies derived from SAB’s Transchromosomic (Tc) Bovine over plasma derived antibodies from humans, at the 2022 Plasma Product Biotechnology Conference in Limassol, Cyprus, which concluded on Nov. 3.

 

SAB’s Chief Operating Officer Christoph Bausch, Ph.D., led two presentations at the conference on Tuesday, Nov. 1.

 

In a presentation titled, “Plasma fractionation and downstream processing of human polyclonal antibodies from the DiversitAb platform,” Dr. Bausch presented an overview of SAB’s novel immunotherapy platform utilizing a specialized manufacturing process to enable a scalable and reliable production of targeted, higher-potency neutralizing antibody products than has been previously possible. The platform can reliably and rapidly produce large quantities of fully-human immunoglobulins against a variety of disease targets, such as viruses, bacteria, toxins, and cancers, without the need for convalescent plasma from human donors with a significantly simplified and controlled process. Tc Bovine, SAB’s genetically engineered cows, mount the same immune response as humans, only with a much higher concentration of targeted neutralizing antibodies. In addition, by eliminating the need to identify, screen, and draw blood from recovering volunteers, SAB’s approach opens the door to polyclonal antibody therapeutics that are potentially more potent, safer, and longer-lasting than current antibody therapies.

 

“SAB’s platform is a major advancement in plasma science and allows for a large supply of neutralizing, fully-human antibodies that can be targeted to treat a number of challenging diseases,” Dr. Bausch said. “Our novel approach to creating high-potency, high-avidity antibodies that naturally activate cellular immunity using our transchromosomic cows has the potential to profoundly change how we approach and treat a wide range of diseases.”

 

Titled “Phase 2 efficacy and safety of two novel SAB immunotherapies against respiratory disease indications associated with highly mutating viruses​,” Dr. Bausch’s second presentation outlined

 


 

data on SAB-185 for COVID-19 and SAB-176 for seasonal and pandemic influenza. The data show that SAB-185 and SAB-176 are highly effective against variants of several highly mutating viruses associated with the diseases, a major challenge in currently available treatments for COVID-19 and influenza.

 

Data from the in vitro neutralizing capacity of SAB-185 was tested against 10 variant SARS-CoV-2 strains, including several Omicron variants. SAB-185 exhibited equivalent neutralization of the Munich, Alpha, Beta, Gamma variants and a variant isolated from an immunocompromised patient (D144-146) and retained neutralization of the Delta variant AY.1 and multiple Omicron variants from BA.1 through BA.5, with only modest losses of neutralization activity. For in vivo protection studies, SAB used a human ACE2 (hACE2) transgenic Syrian hamster model that exhibits rapid lethality after intratracheal SARS-CoV-2 challenge with the Munich, Alpha, Beta, Delta, and D144-146 variants; the Omicron B.1.1529 variant resulted in a delayed, less severe, and non-lethal disease. Prophylactic SAB-185 treatment protected the hamsters from death and minimized clinical signs of infection when challenged with the variant viruses tested.

 

Also outlined was a Phase 2a, Randomized, Double-Blind Trial in H1N1 Challenged Adults, which showed that SAB-176 met its primary endpoint of reducing the nasopharyngeal viral load in subjects challenged with H1N1 A/California/2009-like virus. SAB-176 also met secondary endpoints of reducing symptoms by Day 4 and shortened the timeframe of the ability to culture virus in vitro, suggesting reduced viral shedding, and was safe and well tolerated. Further, while SAB-176 was developed against recent seasonal influenza A and B strains, it also demonstrated efficacy against the 2009 pandemic H1N1 strain in this clinical trial. These clinical results were anticipated as SAB-176 showed significant preclinical HAI titers to multiple current and previous seasonal Type A and Type B influenza strains.

 

“SAB’s data on SAB-176 and SAB-185 validated that our platform delivers on its promise and can create fully-human antibodies that offer much broader efficacy in highly mutating pathogens,” Dr. Bausch said. “The data show the antibodies cross react to mutating strains, preventing additional mutations, and shorten the time of infectious viral shedding to reduce the spread of disease. These components are critical in developing effective innovative future treatments.”

 

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. 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-176, SAB-185, and 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