Item 7.01 Regulation FD Disclosure. On April 22, 2026, SAB Biotherapeutics, Inc., a Delaware corporation (the “Company” or “SAB BIO”) made available a presentation that includes additional information regarding the Company’s Phase 1 HUman anti-thymocyte biologic in first-in-MAN (HUMAN) clinical trial of SAB-142 (the “Presentation”).…
SAB BIO is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) to treat and prevent immune and autoimmune disorders. Using advanced genetic engineering and antibody science, SAB BIO developed a proprietary technology which holds the potential to generate additional novel therapeutic candidates utilizing the human immune response, without the need for human donors or convalescent plasma. SAB BIO has optimized genetic engineering in the development of transchromosomic cattle, or Tc-Bovine, to produce hIgG. SAB BIO’s drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, hIgGs that can address a wide range of serious unmet needs in human diseases. The Company’s lead candidate, SAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to change the T1D treatment paradigm by delaying onset and potentially preventing disease progression of Stage 3 T1D patients. SAB-142 is currently being evaluated in newly diagnosed Stage 3 autoimmune T1D patients in a registrational Phase 2b clinical trial called SAFEGUARD. For more information, visit www.sab.bio.
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Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On April 22, 2026, SAB Biotherapeutics, Inc., a Delaware corporation (the “Company” or “SAB BIO”) made available a presentation that includes additional information regarding the Company’s Phase 1 HUman anti-thymocyte biologic in first-in-MAN (HUMAN) clinical trial of SAB-142 (the “Presentation”). On April 22, 2026, the Company also issued a press release announcing the release of the data set forth in the Presentation (the “Release”). A copy of the Release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K. A copy of this Presentation is furnished herewith as Exhibit 99.2 to this Current Report on Form 8-K. The Presentation is also available on the investor relations section of the Company’s website. Information contained on the Company’s website is not incorporated by reference into this Current Report on Form 8-K, and you should not consider any information on, or that can be accessed from, the Company’s website as part of this Current Report on Form 8-K.
Forward-Looking Statements
Certain statements made in this Current Report on Form 8-K and in the Release 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 statements about the development and clinical trial results of the Company’s 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. 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.
Filed exhibits (2)
EX-99.1 (by filename) sabs-ex99_1.htm
EX-99.1
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sabs-ex99_1.htm
EX-99.1
EX-99.1
Exhibit 99.1
SAB BIO Presents Additional Clinical and Mechanistic Data from SAB-142 Phase 1 Trial in Adult Patients with Established Autoimmune Type 1 Diabetes at IDS 2026
All 4 T1D participants receiving SAB-142 showed C-peptide preservation with 3 of the 4 participants showing a super responder profile concomitant with T cell exhaustion
T1D participants receiving SAB-142 showed improved glycemic control
MIAMI, April 22, 2026 -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing a fully human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today presented additional clinical and mechanistic data from the Phase 1 HUman anti-thymocyte biologic in first-in-MAN (HUMAN) clinical trial of SAB-142 at the 21st Immunology of Diabetes Society (IDS) Congress in Brisbane, Australia.
The additional data presented for SAB-142 highlighted C-peptide preservation with a super responder profile among 3 of the 4 participants with T1D, correlated with evidence of CD4+ T conventional (Tconv) cell exhaustion. Other findings presented include improved glycemic co…