SABSW SAB Biotherapeutics Inc

 

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): January 28, 2025

 

 

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.)
777 W 41st St Suite 401
Miami Beach, Florida				33140
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 305 845-2813

 

(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:

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		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. ☐

 

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Item 8.01 Other Events.

On January 28, 2025, SAB Biotherapeutics, Inc., a Delaware corporation (the “Company” or “SAB”), issued a press release announcing the topline Phase 1 clinical results for SAB-142, the Company’s human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (the “Release”). The Company will give a presentation (the “Presentation”) and discuss the results of the clinical trial during a live webinar event at 8:00 a.m. Eastern Time on January 28, 2025.

Copies of each of the Release and Presentation are attached hereto as Exhibit 99.1 and Exhibit 99.2, respectively, and are incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

Exhibit Number	Description
99.1	Press Release of the Company, dated January 28, 2025
99.2	Presentation of the Company, dated January 28, 2025
104	Cover Page Interactive Data File-the cover page XBRL tags are embedded within the Inline XBRL document.

 

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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.

			SAB Biotherapeutics, Inc.
Date:	January 28, 2025	By:	/s/ Samuel J. Reich
			Samuel J. Reich Chief Executive Officer

 

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SAB BIO Announces Positive Topline Phase 1 Clinical Results with Potentially Disease-Modifying T1D Therapy SAB-142

MIAMI, January 28, 2025 – SAB BIO (Nasdaq: SABS), (“SAB BIO” or the “Company”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced positive topline data from a Phase 1 trial of SAB-142 in a single-ascending dose among healthy volunteers. The study met its primary objectives related to safety and pharmacodynamic activity enabling SAB-142 to advance to Phase 2b clinical development.

“I am particularly excited with the analysis of the results of our Phase 1 trial, as it marks the successful achievement of another critical milestone for SAB-142,” stated Samuel J. Reich, Chairman and CEO of SAB BIO. “These data show clear and positive pharmacologic activity and strong safety profile for SAB-142, and underscore SAB-142’s potential to change the lives of people impacted by type 1 diabetes. With our initial study objectives met, we believe SAB-142 is now well-positioned to be a transformative therapy for type 1 diabetes, and we look forward to advancing this product candidate into Phase 2b clinical development in 2025.”

Phase 1 Trial Summary Data

The SAB-142 Phase 1 trial was designed as a randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study among healthy volunteers and one cohort of participants with T1D. The objectives include establishing the safety, tolerability, pharmacokinetic (PK), immunogenicity and pharmacodynamic (PD) profile for SAB-142. The topline results reported today showed the following outcomes among healthy volunteer cohorts:

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“Our topline data, which we plan to discuss in further detail at our webinar this morning, successfully demonstrates SAB-142’s impactful autoimmune response,” said Dr. Alexandra Kropotova, M.D., MBA, Executive Vice President and Chief Medical Officer at SAB BIO. “This is consistent with what we’ve seen preclinically, and we believe this validates SAB-142’s unique role as potentially the first and only fully human biologic with a validated and broad mechanism of action to enable outpatient dosing to delay the onset or progression of type 1 diabetes.”

Based on the data, SAB BIO plans to advance SAB-142 into a Phase 2b trial in 2025 to evaluate the therapeutic candidate in adult and pediatric patients with new-onset T1D.

Webinar Details and Registration Information

Today’s webinar will feature presentations from SAB BIO’s management team and T1D Key Opinion Leader (KOL), Michael Haller, MD, the division chief of the Pediatric Endocrinology Division at the University of Florida and Silverstein Family Eminent Scholar Chair in Pediatric Endocrinology.

Date: Tuesday, January 28, 2025

Time: 8:00 a.m. ET

Register for the event here or join the conference call through the Events section of the SAB BIO Company website.

A live question and answer session will follow the formal presentations. A replay of the call will be available in the Presentation section of the SAB BIO Company website upon conclusion of the event.

About SAB BIO

SAB BIO (SAB) is a clinical-stage biopharmaceutical company focused on developing human, multi- targeted, high-potency immunoglobulins (IgGs), without the need for human donors or convalescent plasma, to treat and prevent immune and autoimmune disorders. The Company’s lead asset, SAB-142, targets T1D with a disease-modifying therapeutic approach that aims to change the treatment paradigm by delaying onset and potentially preventing disease progression. Using advanced genetic

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engineering and antibody science to develop Transchromosomic (Tc) Bovine™, the only transgenic animal with a human artificial chromosome, SAB’s DiversitAb™ drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, human IgGs that can address a wide range of serious unmet needs in human diseases without the need for convalescent plasma or human donors. For more information on SAB, visit: https://www.SAB.bio/ and follow SAB on Twitter and LinkedIn.

Forward-Looking Statements

Certain statements made in this current report 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,” “to be,” “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 data, development, clinical results, and efficacy of our T1D program and other discovery programs.

These statements are based on the current expectations of SAB BIO 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, as may be amended or supplemented from time to time, 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 BIO 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

Media Relations:

Kaelan Hollon,

Vice President of Communications
khollon@sab.bio

Investor Relations:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

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Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com

 

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SAB BIO INNOVATION DAY ACCELERATING DISEASE-MODIFYING TREATMENTS IN AUTOIMMUNITY January 28, 2025 (Nasdaq: SABS) EXHIBIT 99.2

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Today’s Speakers Chairman and CEO Samuel Reich Alexandra Kropotova, MD Michael Haller, MD Chief Medical Officer & EVP Professor and Chief Pediatric Endocrinology University of Florida

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Forward-Looking Statements 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. These forward-looking statements include, but are not limited to, statements regarding future events, including, the data, development, clinical results, and efficacy of our T1D program and other discovery programs. 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. © 2025 SAB BIOTHERAPEUTICS, INC

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Welcome and Opening Comments Samuel J. Reich Chairman and Chief Executive Officer

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Today’s Agenda Opening Comments Samuel J. Reich SAB-142: Phase 1 Study Design and Safety Profile Alexandra Kropotova, MD Q&A All Speakers SAB-142: PD data, Phase 2 Plan and Overview Michael Haller, MD

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Michael J. Haller, MD, Pediatric Endocrinologist © 2025 SAB BIOTHERAPEUTICS, INC. Division Chief of the Pediatric Endocrinology Division at the University of Florida Silverstein Family Eminent Scholar Chair in Pediatric Endocrinology Dr. Haller has been involved in type 1 diabetes research since the early 1990s and has published over 200 manuscripts and more than 20 reviews/book chapters on type 1 diabetes pathogenesis, prevention, and interdiction. He is the principal investigator or co-investigator on numerous studies funded by the NIH, Breakthrough T1D, and the Helmsley Charitable Trust.  Dr. Haller's research focuses on predicting, preventing, and ultimately reversing type 1 diabetes through the use of immunotherapeutics. Dr. Haller is the Principal Investigator of the U. Florida TrialNet Clinical Center, chairs the TEDDY Clinical Implementation Committee, and was the PI of the UF/Stanford ECHO Collaborative. He has received the Mary Tyler Moore Excellence in Clinical Research Award and the University of Florida Outstanding Clinical Research Scientist award.

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Type 1 Diabetes is One of the Greatest Health Challenges of Our Lifetime 1. https://www.breakthrought1d.org/explore-research/research-strategy/ 2. https://www.t1dindex.org/ 35 years of healthy life lost, on average, per person ~1.4M ~9.4M ~16.4M People with T1D globally by 20402 People with T1D globally in 20242 People with T1D cases in the US1

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It’s time to change the story. We can change the lives of the millions of people impacted by T1D through unique disease-modifying therapies like SAB-142.

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SAB-142 Phase 1 Study Design and Safety Profile Alexandra Kropotova, MD, MBA Chief Medical Officer

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SAB-142 has Established MOA to Potentially Control or Prevent T1D Over the Entire Life Span Indication 2: Stage ½: “Delay the onset of T1D Indication 1: “Delay the progression of Stage 3” Indication 3: “Maintenance of Stage 3” Genetic Risk Immune Activation Immune Response Stage 1 Starting Point 15x increased risk of T2D in those with relatives with disease Immune Activation Beta cells are attacked Immune Response Development of single autoantibody Normal Blood Sugar ≥ 2 autoantibodies Abnormal Blood Sugar ≥ 2 autoantibodies Clinical Diagnosis ≥ 2 autoantibodies Long-standing Type 1 Diabetes Stage 2 Stage 3 Stage 4 Indication 4: “Prevention of transplant rejection in Stage 4 patients receiving islet cell transplantation © 2025 SAB BIOTHERAPEUTICS, INC. Re-dosing is the key!

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SAB-142: Potential Best-In-Class T1D Immunotherapy © 2025 SAB BIOTHERAPEUTICS, INC. Phase 1 topline results support advancement to Phase 2b SAFEGUARD study in adult and pediatric patients with new onset T1D SAB-142 demonstrated clinically validated multi-target MOA with sustained immunomodulation in a Phase 1 trial Phase 1 clinical data confirm SAB-142 is fully human and not immunogenic Doesn’t cause serum sickness Doesn’t cause anti-drug antibodies Phase 1 clinical data demonstrate sustained “T-cell exhaustion” signature Clinically validated by rabbit ATG and other T1D immunomodulatory drugs Proven to correlate with C-peptide preservation Phase 1 clinical data strongly position SAB-142 for potentially safe chronic dosing

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SAB-142-101 Study Design © 2025 SAB BIOTHERAPEUTICS, INC. Data generated for doses: 0.03, 0.1, 0.5, 1.5, and 2.5mg/kg IV 2 cohorts at 2.5mg/kg target dose Dosing: IV infusion on Day 1 and 2 Safety & Tolerability PK Data Immunogenicity: ADA Proof of Biological Activity: FACS and Cytokines

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Majority of adverse events (AEs) are mild, associated with Day 1-2 infusions and resolved by the end of the first week SAB-142 Safety Profile Enables Desired Ambulatory Dosing © 2025 SAB BIOTHERAPEUTICS, INC. Safety profile enables ambulatory dosing Overall summary of treatment emergent adverse events (safety analysis set) Day 1 to 7 Day 8-180 Category Pooled Placebo HV (N=14)n (%) Pooled SAB-142 HV (N=40)n (%) Pooled Placebo HV (N=14)n (%) Pooled SAB-142 HV (N=40)n (%) Number of participants with any: TEAEs 8 (57.1%) 36 (90.0%) 6 (42.9%) 18 (45.0%) TEAEs by Severity: Mild 6 (42.9%) 2 (5.0%) 2 (14.3%) 13 (32.5%) Moderate 2 (14.3%) 3 (7.5%) 4 (28.6%) 4 (10.0%) Severe 0 14 (35.0%) * 0 1 (2.5%) Life-threatening 0 17 (42.5%) * 0 0 Death 0 0 0 0 Treatment-related TEAEs by Severity: Mild 3 (21.4%) 1 (2.5%) 0 4 (10.0%) Moderate 2 (14.3%) 3 (7.5%) 1 (7.1%) 1 (2.5%) Severe 0 14 (35.0%) 0 0 Life-threatening 0 17 (42.5%) 0 0 Death 0 0 0 0 7 Cohorts of Healthy Volunteers (HVs) Total n=54, 40 HVs on SAB-142 and 14 on Placebo Most frequent AEs: Headaches: typical for all T-cell engaging therapies, associated with Days 1-2 *Transient lymphopenia: anticipated PD effect; rapidly self-resolves within 1-3 days Infusion-related reactions (IRRs): CRS: flu-like symptoms, Grade 1 (mild) only, Day 1-2 symptoms Infusion-site reactions (ISR): erythema, tenderness, phlebitis No drug-related SAEs No serum sickness, no AEs associated with ADAs No decrease in RBCs, no neutropenia, no lymphopenia or thrombocytopenia from Day 7 on

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SAB-142 Demonstrated MOA to Deliver Potentially Best-in-Class T1D Immunotherapy © 2025 SAB BIOTHERAPEUTICS, INC. No sustained lymphodepletion (Unlike rabbit ATG that causes decrease in CD4+ T-cells for up to 2 years) No sustained total lymphodepletion No sustained CD4+ and CD8+ T-cell lymphodepletion No sustained B-cell lymphodepletion

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SAB-142 Doesn’t Deplete Any Cells: No Difference vs. PBO and Baseline From Day 7 Onward © 2025 SAB BIOTHERAPEUTICS, INC. 4.35 No RBC depletion No neutropenia No thrombocytopenia Sustained immunomodulation mostly through T-cell exhaustion without any sustained cell depletion

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SAB-142 Shown Not to be Immunogenic At the target dose (2.5mg/kg), both cohorts of SAB-142 didn’t generate anti-SAB-142 antibodies in HVs This demonstrated that SAB-142, fully human IgG pAbs, is less immunogenic than Thymoglobulin, rabbit IgG pAbs* *MRD=1:10 © 2025 SAB BIOTHERAPEUTICS, INC. CONCLUSION: Following a single IV infusion of SAB-142, there are no ADAs at target doses. ADA Assay Design No immunogenicity at target dose level

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SAB-142-101 Topline Data Confirms Potential for Safe and Reliable Lifetime Dosing © 2025 SAB BIOTHERAPEUTICS, INC. Why is it important? Serum sickness (SS) is a hypersensitivity reaction, a result of the formation of immune complexes between human proteins and heterologous (non-human) proteins SS is observed in >70% adults and children treated with rATG; Grade 3-4 SS is observed in >50%; requires treatment with steroids1 Re-treating patients with treatments causing SS is likely to result in higher rate and severity of AEs No serum sickness in 100% randomized Healthy Volunteer subjects No ADAs in two 2.5mg/kg cohorts Topline data confirms competitive safety and advantageous immunogenicity profile Why is it important? Biologics may trigger formation of antidrug antibodies (ADAs). ADAs may affect patient safety and treatment efficacy Both rATG and teplizumab are highly immunogenic. 68% of patients treated with rATG develop ADA2. 57% of patients treated with teplizumab develop ADAs, 46% developed neutralizing ADAs Re-treating patients is likely to cause increased ADA rates and impact on PK and consequently on efficacy

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01 Fully Human 02 Multi-target Directly induces CD4+ and CD8+ exhaustion phenotype without lymphodepletion High-titer, high-avidity multi-target modality directly targets multiple receptors on CD4+ and CD8+ cells 03 High responder rate 100% Immunological Response achieved 100% of subjects dosed with SAB-142 target dose 2.5mg/kg achieved nearly identical T-cell exhaustion profile + + Fully human biologic Results in no serum sickness and low/no immunogenicity SAB-142 is a highly competitive biologic modality

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SAB-142 Overview, Phase 1 Topline Data, Phase 2 Design Presented by: Michael Haller, MD Professor and Chief, Pediatric Endocrinology  Silverstein Family Eminent Scholar Chair University of Florida SAFEGUARD Chief Investigator and Chair of the SAB-142 Advisory Board

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Type 1 Diabetes Pathogenesis Atkinson, M; Eisenbarth, G.S.; Michels, A. Lancet, 2014 © SAB-142-101 data provided by SAB

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Why C-Peptide vs. A1c vs. Insulin Dose ? J Clin Invest. 2021 Feb 1;131(3):e143011. doi: 10.1172/JCI143011 C-peptide IS the ONLY true measure of Beta Cell Function LONG-TERM risk of complications REDUCED LONG-TERM complication free survival...C-Peptide DCCT / EDIC – C-pep > 0.03 nmol/L associated with reduced Severe Hypoglycemia Automated Insulin - improves A1c . Insulin Use but: Does not delay disease Does not meet the needs / wants / desires of the T1D community © SAB-142-101 data provided by SAB

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Why C-Peptide vs. A1c vs. Insulin Dose ? Trial Outcome Markers Initiative (TOMI) Subjects from multiiple positive/negative studies...Power Lancet - 2023 Breakthrough T1D – Diabetes 2024 © SAThe Lancet Diabetes & Endocrinology, Volume 11, Issue 12, 2023, Pages 915-925, 2023

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Tzield/Teplizumab1992 to 2022: 30 Years

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TZIELD® (teplizumab-mzwv) vs. Thymoglobulin (rabbit ATG)

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Thymoglobulin Depletes and Modulates © SAB-142-101 data provided by SAB

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Thymoglobulin Human Thymus / T-cells > Immunized Rabbit Polyclonal Mix of Rabbit Anti-Human Antibodies FDA approved ~30 years Standard in Renal Transplant – up to 10mg/kg Near complete depletion of Treg and Teff with slow recovery at Transplant dose What about lower dose?

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Thymoglobulin in Type 1 Diabetes George Eisenbarth – 1985 – ATGAM START Trial - 2013 - 6.5mg/kg Low-Dose ATG - 2015 - 2.5mg/kg TrialNet Low-Dose ATG – 2018 – 2.5mg/kg Low-Dose ATG – 2024 - Stage 2 T1D  Diabetes Care. 2024 Feb 1;47(2):285-289. JCI Insight. 2023 Aug 22;8(16):e161812 Diabetes Technol Ther. 2020 Dec;22(12):948-953. Diabetes. 2019 Jun;68(6):1267-1276. Diabetes Care. 2018 Sep;41(9):1917-1925

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T-cell Exhaustion Phenotype is Universally Linked to C-peptide Preservation Responders to low-dose ATG induce CD4+ T cell exhaustion in type 1 diabetes - PubMed Exhausted-like CD8+ T cell phenotypes linked to C-peptide preservation in alefacept-treated T1D subjects - PubMed Remodeling T cell compartments during anti-CD3 immunotherapy of type 1 diabetes - PubMed Autoreactive CD8+ T cell exhaustion distinguishes subjects with slow type 1 diabetes progression - PubMed Partial exhaustion of CD8 T cells and clinical response to teplizumab in new-onset type 1 diabetes - PubMed

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Transient increase in IL-6 and TNF-alpha SAB-142 Demonstrates MOA Analogous to Rabbit ATG Key Parameters Correlative to C-peptide Preservation © SAB-142-101 data provided by SAB Responders to low-dose ATG induce CD4+ T cell exhaustion in type 1 diabetes - PubMed Treg preservation 01 Durable CD4+ exhaustion phenotype 02 03

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Phase 1 topline results support advancement to Phase 2b SAFEGUARD study in adult and pediatric patients with new onset T1D SAB-142 Topline Phase 1 Data from Healthy Volunteer Cohorts SAB-142 demonstrated clinically validated multi-target MOA with sustained immunomodulation in Phase 1 Phase 1 data confirm SAB-142 is fully human and not immunogenic Doesn’t cause serum sickness Doesn’t cause anti-drug antibodies Phase 1 data demonstrate sustained “T-cell exhaustion” signature Clinically validated by rabbit ATG and other T1D immunomodulatory drugs Proven to correlate with C-peptide preservation Phase 1 data strongly position SAB-142 for potentially safe chronic dosing © SAB-142-101 data provided by SAB

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SAB-142 Induces a Sustained Cellular Exhaustion Profile on Both CD4+ and CD8+ T-cell Subsets Demonstrating Superior Multi-target Modality © SAB-142-101 data provided by SAB Shift towards exhaustion profile across multiple markers Sustained CD4+ exhaustion profile Sustained CD8+ exhaustion profile Both CD4 and CD8 T-cells expressing PD-1 and TIGIT notably increase at day 30 and continue to increase through day 120

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SAB-142 Clearly Induces a Sustained Cellular Exhaustion Profile on Both CD4+ and CD8+ T-cell Subsets © SAB-142-101 data provided by SAB SAB-142 induces a sustained cellular exhaustion profile on both CD4+ and CD8+ T-cell subsets demonstrating superior multi-target modality

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SAB-142 Produces Increasing PD-1 MFI Expression Levels on Both CD4+ and CD8+ T-cells Supporting Continued Reprogramming of These Targeted Cells SAB-142 results in PD-1 MFI increase in notable dose-response manner © SAB-142-101 data provided by SAB SAB-142 produces PD1 MFI with tight grouping of individual responders showing 100% of “immunological responders” in Cohorts 4, 5, and 5N

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SAB-142 Demonstrates CD4+Tcell Exhaustion Analogous to Rabbit ATG Exhausted CD4+ T cells (percentage PD-1+KLRG1+CD57– on CD4+ T cells) (n = 279) Low-dose ATG was found to persistently induce expression of coinhibitory receptors (PD-1, KLRG1) on T cells and, thus, exhaustion-like phenotypes in CD4+ T cell populations. Cohorts C4, C5, & C5N Grouped (1.5mg/kg -2.5mg/kg) © SAB-142-101 data provided by SAB SAB-142 CD4+ T cell exhaustion Rabbit ATG CD4+ T cell exhaustion

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SAB-142 Not Only Preserves Tregs but Also Induces T-reg Activation State © SAB-142-101 data provided by SAB SAB-142 T-regulatory cells “sparing” effect demonstrated by no difference vs. baseline and PBO from Day 14 onwards SAB-142 triggers activated state of T-regulatory cells demonstrated by increase in TIGIT+ Tregs by Day 45 that continues to increase through Day 120

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SAB-142 Doesn’t Cause Sustained Total, T or B-cell Lymphodepletion © SAB-142-101 data provided by SAB No sustained total lymphodepletion No sustained CD4+ and CD8+ T-cell lymphodepletion No sustained B-cell lymphodepletion

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Efficacy of Rabbit ATG is Not Associated with the Degree of Lymphodepletion © SAB-142-101 data provided by SAB  Rabbit ATG results in sustained CD4+ decrease for up to 2 years Sustained decrease in CD4+ or CD8+ T-cells has not been shown to correlate with C-peptide preservation Responders to low-dose ATG induce CD4+ T cell exhaustion in type 1 diabetes - PubMed

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SAB-142 Doesn’t Lymphodeplete T Regulatory Cells, Unlike Teplizumab © SAB-142-101 data provided by SAB https://pubmed.ncbi.nlm.nih.gov/28844471/ Within the pool of circulating CD4 T cells, teplizumab reduced Treg more than non-Treg (~58% vs. ~35% change from baseline, respectively) SAB-142 T-regulatory cells “sparing” effect demonstrated by no difference vs. baseline and PBO from Day 14 onwards SAB-142 triggers activated state of T-regulatory cells demonstrated by increase in TIGIT+ Tregs by Day 45 that continues to increase through Day 120 Teplizumab

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SAB-142 CD4+ exhaustion signature CD8+ exhaustion signature Treg preservation No sustained lymphodepletion (Tconv and/or Tregs) No anti-drug antibodies No serum sickness C-peptide preservation Primary endpoint 39 SAB-142 exhibits multi-target T-cell exhaustion profile and Treg-sparing without sustained lymphodepletion analogous to naturally occurring spontaneous partial remission known as honeymoon period SAB-142 Demonstrated Competitive MOA with T-Cell Exhaustion Signature Correlated with C-peptide Preservation © SAB-142-101 data provided by SAB

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SAB-142 Topline Data Supports Potentially Best-in-Class T1D Immunotherapy © SAB-142-101 data provided by SAB TARGET pathway 1 TARGET pathway 2 CD4+ Exhaustion profile CD8+ Exhaustion profile Target dosing over 2-3 days vs. 12-14 days with teplizumab Infusion over ~6 hrs vs 12 hrs in MELD-ATG MOA indicates “exhaustion” profile across CD4+ and CD8+ T-cells, strongly correlated with C-peptide preservation SAB-142 is positioned for chronic dosing due to no sustained lymphodepletion SAB-142 has a competitive dosing regimen in ambulatory setting Combined Treg preservation and activation, cellular differentiation shift to a T-cell memory phenotype, and subsequent increase in CD4+ & CD8+ cellular exhaustion markers collectively contribute to the immune modulation MOA that could result in the sustained restoration of immune tolerance correlated with C-peptide preservation and delaying the onset of T1D. (Jacobsen et al 2023; Riquelme et al, 2018; Yu et al, 2009)

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Robust Clinical Data Generated Across Multiple Clinical Studies of SAB-142 Supports Efficient Full Development Low-Dose rabbit ATG preserved C-Peptide vs. placebo in stage 3 T1D patients informing SAB to pursue SAB-142 in human clinical studies Decline in C-Peptide AUC Mean Over 2 Years SAB-142 demonstrated clinically validated multi-target MOA inducing sustained T-cell exhaustion with no lymphodepletion, serum sickness or anti-drug antibodies 01 Low-Dose rabbit ATG Phase 2 Academic Study by Haller 02 Phase 1 SAD HV Study Phase 1 topline results support MOA competitive to rATG and teplizumab and advancement into a Phase 2B (SAFEGUARD) study Potential registrational Phase 2b Study in Stage 3 T1D patients Primary endpoint being C-peptide along with Time-In-Range (TIR) as the leading clinical end point Global study expected to initiate mid 2025 Interim data expected mid 2026 © SAB-142-101 data provided by SAB

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SAB-142: Multicenter Global Phase 2b in Stage 3 Type 1 Diabetes Patients SAFEGUARD study: SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes United Kingdom (MHRA) Europe (EMA) Australia (TGA) Endpoints Primary: Stimulated C-peptide following 2-hr MMTT at 12 months (detect at least 40% difference with 80% power) Secondary: Lead Clinical end point: Time in Range Other Secondary end points: - Time in Tight Range, Time Below Range Insulin use HbA1c Hypoglycemic episodes Safety Global study expected to initiate mid 2025 Trial design: 142 pediatric, adolescent, and adult patients (5-40 years) Randomized, double-blind, placebo-controlled, dose-ranging study Inclusion criteria: New onset Stage 3 T1D: within 100 days of diagnosis Baseline C-peptide >200 pmol/L Dosing regimen: Intravenous (IV) 0.5 mg/kg on Day 1 and remainder of dose Day 2/3 United States (FDA)  Stage 3 T1D Randomized 1:1:1 High Dose Low Dose Placebo © SAB-142-101 data provided by SAB

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Q&A Session Chairman and CEO Samuel Reich Alexandra Kropotova, MD Michael Haller, MD Chief Medical Officer & EVP Professor and Chief Pediatric Endocrinology University of Florida

v3.24.4

Document And Entity Information	Jan. 28, 2025
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Document Period End Date	Jan. 28, 2025
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Entity Central Index Key	0001833214
Entity Emerging Growth Company	true
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Entity Tax Identification Number	85-3899721
Entity Address, Address Line One	777 W 41st St
Entity Address, Address Line Two	Suite 401
Entity Address, City or Town	Miami Beach
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	33140
City Area Code	305
Local Phone Number	845-2813
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Pre-commencement Issuer Tender Offer	false
Entity Ex Transition Period	false
Convertible Common Stock [Member]
Document Information [Line Items]
Title of 12(b) Security	Common stock, $0.0001 par value per share
Trading Symbol	SABS
Security Exchange Name	NASDAQ
Warrants Each Exercisable for Common Stock [Member]
Document Information [Line Items]
Title of 12(b) Security	Warrants, each exercisable for one share of Common Stock
Trading Symbol	SABSW
Security Exchange Name	NASDAQ

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