First Patient Dosed in SAB BIO’s SAFEGUARD Clinical Trial of SAB-142 for the Treatment of Stage 3 T1D

Rhea-AI Summary

SAB BIO (Nasdaq: SABS) announced the first patient was dosed with SAB-142 in the Phase 2b registrational SAFEGUARD trial on Dec 18, 2025. The trial targets stage 3 type 1 diabetes using a fully human anti-thymocyte immunoglobulin intended as a disease-modifying therapy. Enrollment is ongoing at multiple global sites, including the U.S., Australia, and New Zealand, with European sites joining soon. The company plans to share Phase 2b data in 2H 2027.

Positive

• First patient dosed in Phase 2b SAFEGUARD on Dec 18, 2025
• Global enrollment active: U.S., Australia, New Zealand with Europe joining soon
• Company targets Phase 2b data release in 2H 2027

Negative

• No efficacy readouts available; primary Phase 2b data not expected until 2H 2027

Key Figures

Trial phase Phase 2b SAFEGUARD clinical trial of SAB-142 in Stage 3 T1D

Stage of disease Stage 3 T1D Target population for SAB-142 in SAFEGUARD trial

Data timing 2H 2027 Company guidance to share Phase 2b data

Market Reality Check

$3.77 Last Close

Volume Volume 618,549 is 2.04x its 20-day average of 303,644, showing elevated trading interest pre-announcement. high

Technical Price at 3.96 is trading above the 200-day MA of 2.27, indicating a pre-news uptrend versus longer-term levels.

Peers on Argus 2 Down

Momentum scanner shows 2 biotech peers (e.g., FBLG, AKTX) moving down (median about -6.8%), suggesting some broader sector pressure alongside SABS’ modest -0.75% move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 08	Clinical data update	Positive	-10.8%	Phase 1 SAB-142 data highlighted at ATTD-Asia diabetes meeting.
Nov 13	Earnings and pipeline	Positive	-9.1%	Q3 results, strong cash, runway to 2028, SAFEGUARD initiation update.
Nov 04	Conference presentations	Positive	+0.0%	ISPAD presentations detailing Phase 1 safety, immunomodulation and PK assay.
Nov 04	Investor conferences	Neutral	+0.0%	Participation in UBS, Guggenheim, and Evercore investor conferences.
Sep 19	Clinical data at EASD	Positive	-11.5%	EASD presentations on Phase 1 SAB-142 data and disease-modifying potential.

Pattern Detected

Positive clinical and earnings updates have often been met with flat or negative price reactions, indicating a recurring divergence between news tone and near-term trading.

Recent Company History

Over the last few months, SAB BIO has repeatedly highlighted progress for SAB-142, including multiple Phase 1 data presentations at EASD, ISPAD and ATTD-Asia, as well as initiation of the registrational Phase 2b SAFEGUARD trial. Earnings in Q3 2025 emphasized a strengthened cash position and runway through 2028. Despite generally constructive clinical and financial updates, several of these announcements were followed by negative or flat price moves, forming a pattern relevant to today’s first-patient-dosed milestone.

Market Pulse Summary

This announcement underscores a key milestone for SAB BIO, with the first patient now dosed in its registrational Phase 2b SAFEGUARD trial of SAB-142 for Stage 3 T1D and enrollment underway at global sites. It builds on earlier Phase 1 safety, immunogenicity and pharmacodynamic data presented at major diabetes meetings. Investors may focus on enrollment progress, additional updates expected in 2026, and the company’s plan to share Phase 2b data in 2H 2027 as they track execution risk and development timelines.

Key Terms

phase 2b medical

"dosing of the first patient with SAB-142 in the Phase 2b registrational"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

immunotherapeutic medical

"disease-modifying immunotherapeutic approach to treat stage 3 T1D"

An immunotherapeutic is a treatment that helps the body’s immune system recognize and attack disease, often by boosting, guiding or supplying immune cells and molecules much like training or equipping soldiers to target a specific enemy. Investors care because these therapies can offer long-lasting benefits and large market potential, but they also carry high development costs, long clinical testing timelines and regulatory risk that can dramatically affect company value.

immunogenicity medical

"robust Phase 1 safety, immunogenicity, and pharmacodynamic data"

Immunogenicity is the ability of a substance, such as a vaccine or medication, to provoke an immune response in the body. It matters to investors because high immunogenicity can affect the effectiveness and safety of a product, potentially leading to increased costs or regulatory challenges. Understanding immunogenicity helps assess the long-term viability and market potential of pharmaceutical and biotech investments.

pharmacodynamic medical

"robust Phase 1 safety, immunogenicity, and pharmacodynamic data"

Pharmacodynamic describes how a drug acts on the body — the biological effects it produces, how strong those effects are, and how long they last. For investors, pharmacodynamic data show whether a treatment actually works and at what dose, shaping expectations about a drug’s safety, effectiveness, regulatory success and market potential; think of it like testing how well a key turns a lock and whether it reliably opens the door.

clinical trial medical

"SAFEGUARD clinical trial. SAB-142 is in development as a novel"

A clinical trial is a carefully controlled study in which a new medicine, medical device, or treatment is tested on people to see if it is safe and effective. For investors it matters because trial results determine whether a product can win regulatory approval and reach patients, much like a road test decides if a new car can be sold; positive or negative results can sharply change a company’s prospects and stock value.

cro technical

"including the Australasian Type 1 Diabetes Immunotherapy Collaborative (ATIC), AK Clinical Research, and SAB BIO’s global CRO partner"

CRO stands for Contract Research Organization, a company that helps pharmaceutical and biotech firms manage and carry out clinical trials to test new medicines. For investors, CROs are important because they enable drug companies to develop new treatments more efficiently, potentially accelerating the path to market and affecting the company's growth prospects and success.

AI-generated analysis. Not financial advice.

• Enrollment in the SAFEGUARD trial is ongoing at multiple centers globally
  
• Company on-track to share Phase 2b data in 2H 2027
  

MIAMI, Dec. 18, 2025 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today announced the dosing of the first patient with SAB-142 in the Phase 2b registrational SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes (SAFEGUARD) clinical trial. SAB-142 is in development as a novel, potentially best-in-class, disease-modifying immunotherapeutic approach to treat stage 3 T1D by delaying the progression of disease.

“The first patient treated in the SAFEGUARD study marks a significant milestone for SAB BIO as we are one step closer to advancing our ‘Beyond Insulin’ vision to bring a potentially safe and effective disease modifying therapy, SAB-142, to approval. SAB-142 is a fully human biologic that targets multiple immune cells implicated in T1D without necessarily killing them. SAB-142 is emerging as a potentially best-in-class treatment for people living with T1D,” said Alexandra Kropotova, M.D., MBA, Chief Medical Officer, SAB BIO. “We are focused on the rapid enrollment of our trial with multiple sites activated around the world. The successful initiation of our global Phase 2b trial, combined with robust Phase 1 safety, immunogenicity, and pharmacodynamic data presented earlier this year at major diabetes conferences, provides strong clinical momentum heading into the new year.”

Dr. Kropotova added, “I would like to thank the clinical trial participants, their families, the clinicians, and our colleagues at collaborating institutions, including the Australasian Type 1 Diabetes Immunotherapy Collaborative (ATIC), AK Clinical Research, and SAB BIO’s global CRO partner, for their invaluable contributions to our clinical trials. We look forward to sharing more updates from our Phase 2b SAFEGUARD trial in 2026.”

The SAFEGUARD trial is currently enrolling additional study participants at multiple centers around the globe, including the U.S., Australia, and New Zealand, with European sites joining soon. The first patient in SAFEGUARD was dosed at The Royal Melbourne Hospital (RMH) in Australia by Professor John Wentworth and team.

About the SAFEGUARD Trial
SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes (SAFEGUARD) trial is a double-arm, multi-center Phase 2b study designed to assess the safety, efficacy, and tolerability of SAB-142 in patients with stage 3 new onset T1D. SAB-142 is in development as a novel, potentially best-in-class, disease-modifying immunotherapeutic approach to treat T1D by delaying the progression of disease. SAFEGUARD Part A is a dose-ranging study in adult patients. SAFEGUARD Part B is a randomized double-blind, placebo-controlled, dose-ranging study. Enrolled patients will receive two SAB-142 infusions six months apart. All patients, including the placebo-control group, are eligible for the 12-month long-term extension study upon study completion. Additional details are available on www.clinicaltrials.gov (NCT07187531).

About SAB-142
SAB-142 is a potentially disease-modifying, redosable immunotherapy in clinical development for the treatment of autoimmune type 1 diabetes (T1D). SAB-142 is a multi-specific, fully human anti-thymocyte globulin (hATG) with a mechanism of action analogous to that of rabbit ATG (rATG). rATG has demonstrated in multiple clinical trials the ability to slow disease progression in patients with new- or recent-onset of Stage 3 T1D. SAB-142, like rATG, directly targets multiple immune cells involved in destroying pancreatic beta cells, including modulation of “bad acting” T-lymphocytes like cytotoxic T-cells. By stopping immune cells from attacking beta cells, this treatment has the potential to preserve insulin-producing beta cells.

About SAB BIO
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. 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. 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. For more information, visit www.sab.bio.

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 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, 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

Investor Relations:
Cristi Barnett
ir@sab.bio

Media:
Sheila Carlson
media@sab.bio

FAQ

What did SAB BIO (SABS) announce about SAB-142 on December 18, 2025?

SAB BIO announced the first patient was dosed in the Phase 2b SAFEGUARD trial for SAB-142 on Dec 18, 2025.

What is the purpose of the SAFEGUARD Phase 2b trial for SABS?

The trial is a registrational study testing SAB-142 as a disease-modifying immunotherapy to delay progression of stage 3 type 1 diabetes.

When does SAB BIO expect to share SAFEGUARD Phase 2b data for SABS?

The company plans to share Phase 2b data in 2H 2027.

Where was the first SAFEGUARD patient dosed for SABS?

The first patient was dosed at The Royal Melbourne Hospital in Australia.

Which countries are actively enrolling participants in the SAFEGUARD trial (SABS)?

Enrollment is ongoing in the U.S., Australia, and New Zealand, with European sites joining soon.

What does the SAFEGUARD milestone mean for SABS shareholders?

Dosing the first patient advances the registrational program toward a Phase 2b readout, but no efficacy or approval timelines are confirmed before the 2H 2027 data release.