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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):
September 09, 2024
SAB BIOTHERAPEUTICS, INC.
(Exact name of Registrant as Specified in Its Charter)
Delaware 001-39871 85-3899721
(State or Other Jurisdiction (Commission File Number) (IRS Employer
of Incorporation) Identification No.)
777 W 41st St
Suite 401
Miami Beach 33140
,
Florida
(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:
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 Name of each exchange on which registered
Symbol(s)
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 ((s)/230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 ((s)/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 7.01 Regulation FD Disclosure.
On September 9, 2024, SAB Biotherapeutics, Inc., a Delaware corporation (the
"Company" or "SAB"), issued a press release (the "Release") announcing that
the Company's Chief Medical Officer will provide an update (the "Presentation")
at the European Association for the Study of Diabetes (EASD) 60th Annual
Meeting, on the Company's Phase 1 clinical trial, investigating safety,
tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of SAB-142.
A copy of the Release is filed herewith as Exhibit 99.1, and a copy of the
Presentation is filed herewith as Exhibit 99.2.
The information set forth in this Item 7.01, and in Exhibit 99.1 and Exhibit
99.2, is furnished and shall not be deemed "filed" for purposes of Section 18
of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or
otherwise subject to the liabilities of that section. The information in this
Item 7.01, and in Exhibit 99.1 and and Exhibit 99.2, shall not be deemed to be
incorporated by reference into any filing of the Company under the Securities
Act of 1933, as amended, or the Exchange Act, whether made before or after the
date hereof, except as shall be expressly set forth by specific reference in
such a filing.
Item 9.01 Financial Statements and Exhibits.
Exhibit Number Description
99.1 Press Release of the Company, dated September 9, 2024
99.2 Presentation of the Company, dated September 9, 2024
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: September 9, 2024 By: /s/ Samuel J. Reich
Samuel J. Reich
Chief Executive Officer
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EXHIBIT 99.1
SAB BIO Provides SAB-142 Clinical Trial Progress Update at the European
Association for the Study of Diabetes Annual Meeting
SAB-142 has completed Phase 1 enrollment of all planned cohorts in healthy
volunteers and is progressing to enroll patients with type 1 diabetes in the
last cohort of the study.
Target dose of SAB-142 2.5mg/kg completed with no observation of serum sickness.
SAB-142 remains on track for a topline Phase 1 data readout by the end of the
year.
MIAMI, September 9, 2024 -- SAB BIO (Nasdaq: SABS) (the Company or SAB), a
clinical-stage biopharmaceutical company with a novel immunotherapy platform
developing a human anti-thymocyte immunoglobulin (hIgG) for delaying the onset
or progression of type 1 diabetes (T1D), today will offer a trial update on
SAB-142 during its presentation at the European Association for the Study of
Diabetes (EASD) 60
th
Annual Meeting in Madrid. SABs Executive Vice President and Chief Medical
Officer Alexandra Kropotova, MD, MBA will present Protecting pancreatic beta
cells with multi-target immunotherapy: SAB-142. SAB-142 is a first-in-class
human anti-thymocyte immunoglobulin being developed as a disease-modifying
treatment to delay the onset and progression of T1D.
We are pleased with the continued progress of SAB-142 and its emerging safety
profile to date, noted Dr. Kropotova on the data. Our trial results to date
definitively demonstrate a lack of serum sickness for our SAB-142 compound,
which is a key differentiation compared to rabbit anti-thymocyte globulin.
SAB-142 has demonstrated this fully human anti-thymocyte globulin has an
improved safety benefit and the potential to preserve endogenous C-peptide and
prevent the progression of type 1 diabetes. We continue to gather SAB-142 data
that supports our commitment to developing a disease modifying immunotherapy
to change the lives of people impacted by type 1 diabetes.
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SAB commenced the Phase 1 clinical trial investigating safety, tolerability,
pharmacokinetic, pharmacodynamic, and immunogenicity of SAB-142 in November
2023. The primary objective of the trial is two-fold: (1) to generate data on
differentiated safety and immunogenicity of this human immunoglobulin, and (2)
to establish a proof of biological activity (POBA) for SAB-142.
The Phase 1 study is a randomized, double-blind, placebo-controlled,
single-ascending dose, adaptive design clinical study designed to assess the
safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous
SAB-142 first in healthy volunteers and thereafter in participants with T1D.
Enrollment of healthy volunteers has been completed for all planned cohorts.
SAB has completed the dosing of 2.5mg/kg with SAB-142 its targeted dose -
with no observation of serum sickness. Additionally, SAB has elected to add a
T1D patient cohort to establish safety, tolerability, pharmacokinetic and
immunogenicity profile of SAB-142 in patients with T1D prior to initiation of
an upcoming Phase II SAFEGUARD study in patients with new-onset T1D. SAB is
now progressing to enroll patients with T1D to supplement the last cohort of
the study.
About SAB-142
SAB-142 is a human alternative to rabbit anti-thymocyte globulin (ATG).
SAB-142s mechanism of action is analogous to that of rabbit ATG, which has
been clinically validated in multiple clinical trials for type 1 diabetes,
demonstrating the ability to slow down disease progression in patients with
new or recent onset of Stage 3 type 1 diabetes.
Two clinical trials have shown that a single, low dose of 2.5mg/kg rabbit ATG
has demonstrated the ability to modulate the bodys immune response to help
slow beta cell destruction and preserve the ability of these cells to generate
insulin, which the body needs to regulate blood sugar and carry out all human
activities.
SAB-142, like rabbit ATG, directly targets multiple immune cells involved in
destroying pancreatic beta cells. By stopping immune cells from attacking beta
cells, this treatment has the potential to preserve insulin-producing beta
cells. However, most humans treated with rabbit ATG develop serum sickness and
anti-drug antibodies from exposure to the rabbit-derived antibody. SAB-142 is
a human antibody, intended to allow safe, consistent re-dosing for type 1
diabetes, a lifelong chronic disease, without
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the potential risk of inducing major adverse immune reactions that can occur
with the administration of an animal ATG.
About SAB Biotherapeutics, Inc.
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 Companys 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 engineering and antibody science to
develop Transchromosomic (Tc) BovineTM, the only transgenic animal with a
human artificial chromosome, SABs DiversitAbTM drug development production
system can 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:
www.SAB.bio
and follow SAB on
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 development and
efficacy of our T1D program and other discovery programs, including the
results of our clinical studies related to SAB-142.
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
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or impossible to predict, and these risks and uncertainties may cause our or
our industrys 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 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
Kaelan Hollon
Media Relations:
khollon@sab.bio
Investor Relations:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com
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SAB Biotherapeutics European Association for the Study of Diabetes 60th Annual
Meeting INNODIA SYMPOSIUM Madrid, Spain September 9, 2024 (c) 2024 SAB
BIOTHERAPEUTICS, INC. EXHIBIT 99.2
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Protecting Pancreatic Beta Cells with Multi-target Immunotherapy: SAB-142 (c)
2024 SAB BIOTHERAPEUTICS, INC.
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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
SABs 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 SABs 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 SABs 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
SABs 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. (c) 2024 SAB
BIOTHERAPEUTICS, INC.
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SAB-142 Value: Fully Human Multi-target Immunotherapy SAB-142 is the first and
only fully human multi-target, multi-epitope biologic to enable safe and
reliable dosing over a patients lifetime to delay onset and/or progression of
Type 1 Diabetes (c) 2024 SAB BIOTHERAPEUTICS, INC.
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Multi-target capability in a single therapeutic Natural multi-epitope targeted
hIgG selected and produced in vivo Ability to target multiple T1D disease
pathways at once Specifically driven high-potency titers and avidity Potential
for better safety & reliable re-dosing due to low risk for immunogenicity and
lack of serum sickness Natural mixture of many human immunoglobulins that bind
to multiple epitopes is regulated as a single product SAB-142 Human
Anti-Thymocyte Immunoglobulin: Next Generation of Biologics Key product
differentiators vs monoclonal antibodies, animal biologics, or small molecule
modalities TARGET pathway 1 TARGET pathway 2 TARGET Pathway 1 TARGET Pathway 2
(c) 2024 SAB BIOTHERAPEUTICS, INC.
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Complex Pathophysiology of T1D Demands Multi-Target Approach SAB-142 Preserves
Treg Cells Identical in vitro Binding vs Thymoglobulin SAB-142 vs. Rabbit
THYMO-AF488 SAB-142 CD8 T Cells - Reduction Live CD8+ cells * * * * Treg Cells
No Change Live CD4+CD25+Foxp3+ * Indicates p<0.05 compared to negative
control hIgG (c) 2024 SAB BIOTHERAPEUTICS, INC.
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SAB-142 Production is Similar to Thymoglobulin(R) (c) 2024 SAB BIOTHERAPEUTICS,
INC. rpAbs hpAbs Thymocytes Thymocytes Rabbit Immunization Rabbit Antibody
Production Plasma Collection Purification Rabbit Antibodies SAB-142Anti-Thymocyt
e Globulin (Human)
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Serum Sickness Associated with Heterologous Biologics Pathophysiology and
treatment Serum sickness is a type III hypersensitivity reaction that is
induced by administration of foreign proteins Mediated by immune complex
deposition, which leads to complement activation and recruitment of
neutrophils by interaction of immune complexes with Fc immunoglobulin G (IgG)
receptors Circulating immune complexes result in blotchy rash, peripheral
edema, join pain, nephrotoxicity, vasculitis classically seen with serum
sickness Typically managed with systemic steroids administered over several
days Clinical Pathology (c) 2024 SAB BIOTHERAPEUTICS, INC.
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SAB-142 Offers Several Distinct Advantages Over Thymoglobulin(R) Majority of
patients develop grade 3-4 serum sickness Safety Efficacy No serum sickness
due to fully human product Lower half-life and inability to re-dose due to
anti-drug antibodies No immunogenicity allows safe and reliable re-dosing
DiversitAbTM antibodies Safety & Immunogenicity Database in >700 Subjects*
ZERO Subjects with Serum Sickness ZERO Subjects with neutralizing ADA Safe and
reliable Re-dosing with SAB-142 SAB-142 * Total patients dosed across multiple
DiversitAbTM products (c) 2024 SAB BIOTHERAPEUTICS, INC.
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HUMAN Clinical Trial STUDY DESIGN Phase 1: First in Human, Randomized,
Double-Blind, Placebo-controlled, Single Ascending Dose trial in healthy
volunteers with adaptation to patients with T1D SAB-142 doses: 0.03mg/kg, 0.1,
0.5, 1.5 & 2.5mg/kg ENDPOINTS Primary end point: Acute (serum sickness, CRS)
and long-term (rate of infections) safety Secondary end points: pharmacokinetics
, pharmacodynamics, immunogenicity/ADA Major outcomes: Validate safety
superiority based on the anticipated 0% of serum sickness and nAbs Validate
MoA of SAB-142 in humans Proof of Biological Activity (POBA): change vs
baseline in PD markers such as CD3, CD8, CD4, CD4/CD8 ratio, Tregs, and other
subsets compared to rATG (cross study) (c) 2024 SAB BIOTHERAPEUTICS, INC.
Fully HUman Anti-Thymocyte Biologic in First-in-MAN
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Established Differentiated Safety Profile of SAB-142 to Allow Safe and
Reliable Dosing: Proven No Serum Sickness Study Progress Completed all planned
HV cohorts Completed dosing with 2.5mg/kg of SAB-142, preliminary target dose
Established differentiated safety profile to allow safe and reliable dosing:
proven no serum sickness Completed all planned HV cohorts (c) 2024 SAB
BIOTHERAPEUTICS, INC - CONFIDENTIAL.
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SAFEGUARD Trial: Global Collaboration Across Key T1D Centers United States
(FDA) United Kingdom (MHRA) Europe (EMA) Australia (TGA) SAFety and
Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression
of type 1 Diabetes SAFEGUARD (c) 2024 SAB BIOTHERAPEUTICS, INC. Filed in US
and ex-US 4 INDs , 1 CTA, & 1 CTN 8 Clinical Trials Span from Phase 1 to
Phase 3 across 3 indications
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SAFEGUARD Study Design A Phase 2B, Randomized, Double-Blind, Placebo-Controlled,
Dose-Ranging Study Evaluating the Efficacy and Safety of SAB-142 for the
delay of progression of Type 1 Diabetes in new/recent onset Stage 3 T1D
patients (c) 2024 SAB BIOTHERAPEUTICS, INC.
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Questions? Contact us @ SAFEGUARD@sab.bio www.safeguardstudy.com www.safeguardt1
dtrial.net (c) 2024 SAB BIOTHERAPEUTICS, INC.
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