SAB BIO Announces Additional Phase 1 Data for SAB-142 in Adult Patients with Established Autoimmune Type 1 Diabetes

Rhea-AI Summary

SAB BIO (Nasdaq: SABS) reported additional Phase 1 data for SAB-142 in adults with established type 1 diabetes showing early signals of C‑peptide preservation at Day 120 in treated participants versus placebo. The small cohort (n=6; 4 treated, 2 placebo) showed biomarker evidence of T‑cell exhaustion. SAB‑142 has advanced to the registrational Phase 2b SAFEGUARD trial with topline data expected 2H 2027.

Positive

• Treated adults (n=4) showed C‑peptide preservation at Day 120 versus baseline
• Biomarker evidence of T‑cell exhaustion consistent with intended mechanism
• SAB‑142 advanced to Phase 2b SAFEGUARD with topline data expected 2H 2027

Negative

• Very small Phase 1 T1D cohort (total n=6) limits statistical confidence
• One placebo participant discontinued early, reducing placebo comparative data
• Company states no statistical conclusions can be made from these exploratory results

News Market Reaction – SABS

+6.77% 2.2x vol

16 alerts

+6.77% News Effect

+18.3% Peak in 25 hr 32 min

+$15M Valuation Impact

$241M Market Cap

2.2x Rel. Volume

On the day this news was published, SABS gained 6.77%, reflecting a notable positive market reaction. Argus tracked a peak move of +18.3% during that session. Our momentum scanner triggered 16 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $15M to the company's valuation, bringing the market cap to $241M at that time. Trading volume was elevated at 2.2x the daily average, suggesting notable buying interest.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

T1D cohort size: 6 participants (n=6) SAB-142 treated: 4 participants (n=4) Placebo participants: 2 participants (n=2) +5 more

8 metrics

T1D cohort size 6 participants (n=6) Established adult T1D Phase 1 cohort

SAB-142 treated 4 participants (n=4) Received SAB-142 at 2.5 mg/kg in Phase 1 T1D cohort

Placebo participants 2 participants (n=2) Placebo arm in Phase 1 T1D cohort; 1 completed to Day 120

Dose level 2.5 mg/kg SAB-142 dose given to treated T1D participants in Phase 1

C-peptide threshold >0.2 nmol/L Residual beta cell function required at baseline

Day 120 endpoint 120 days post-dose Timepoint for exploratory efficacy assessments in Phase 1

TN19 placebo cohort 31 participants (n=31) Historical placebo MMTT C-peptide AUC dataset used for modeling

C-peptide decline slope -0.6108 Linear slope applied to estimate placebo C-peptide decline in model

Market Reality Check

Price: $4.59 Vol: Volume 174,922 is below 2...

low vol

$4.59 Last Close

Volume Volume 174,922 is below 20-day average of 290,818 ahead of this data update. low

Technical Price $3.84 is above 200-day MA of $2.92, but still 41.82% below 52-week high.

Peers on Argus

SABS was up 1.32% pre-announcement with light volume, while only one momentum pe...

1 Up

SABS was up 1.32% pre-announcement with light volume, while only one momentum peer (AKTX) showed a 4.94% upside move and key affinity peers generally moved independently, pointing to stock-specific drivers over broad sector rotation.

Common Catalyst Some peers, such as Q32 Bio, had earnings and corporate updates, but these are unrelated to SABS’s T1D clinical data.

Previous Clinical trial Reports

5 past events · Latest: Dec 18 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 18	Phase 2b dosing start	Positive	-0.3%	First patient dosed in registrational Phase 2b SAFEGUARD trial for Stage 3 T1D.
Dec 17	Phase 1 confirmatory data	Positive	-0.8%	Positive confirmatory Phase 1 results with favorable safety and PD profile for SAB-142.
Jan 28	Phase 1 topline data	Positive	-52.5%	Positive topline Phase 1 data in healthy volunteers meeting safety and PD objectives.
Jan 23	R&D webinar announcement	Positive	-1.3%	Announcement of R&D webinar to review Phase 1 topline results for SAB-142.
Sep 09	Trial progress update	Positive	+2.4%	Update noting Phase 1 enrollment completion and no serum sickness at target dose 2.5mg/kg.

Pattern Detected

Clinical trial announcements for SAB-142 have generally been positive but often coincided with negative one-day price reactions, indicating a pattern of the stock selling off or lagging on good clinical news.

Recent Company History

Across recent clinical trial news, SAB BIO has repeatedly highlighted progress for SAB-142 in type 1 diabetes: positive Phase 1 topline data on Jan 28, 2025, confirmatory Phase 1 safety and PD results on Dec 17, 2025, and first patient dosed in the Phase 2b SAFEGUARD trial on Dec 18, 2025. Despite these constructive updates, four of five events saw negative next-day moves, framing today’s additional Phase 1 C-peptide data within a history of cautious market reactions.

Historical Comparison

-10.5% avg move · In the past 18 months, SAB BIO’s 5 clinical-trial headlines for SAB-142 saw an average next-day move...

clinical trial

-10.5%

Average Historical Move clinical trial

In the past 18 months, SAB BIO’s 5 clinical-trial headlines for SAB-142 saw an average next-day move of -10.5%. Today’s additional Phase 1 C-peptide data fits into this ongoing development arc.

Clinical updates show a steady SAB-142 path: Phase 1 enrollment and progress, topline safety/PD data, confirmatory Phase 1 results, then first dosing in the registrational Phase 2b SAFEGUARD trial, now supplemented by additional Phase 1 C-peptide preservation data.

Market Pulse Summary

The stock moved +6.8% in the session following this news. A strong positive reaction aligns with the...

Analysis

The stock moved +6.8% in the session following this news. A strong positive reaction aligns with the constructive nature of this Phase 1 update, which showed C-peptide preservation signals in 4 SAB-142–treated adults versus decline in placebo. Historically, however, SAB BIO’s clinical headlines have averaged a -10.5% next-day move, so prior patterns reflected skepticism. Investors monitoring sustainability might focus on upcoming SAFEGUARD Phase 2b milestones and how future data compare with these early biomarker trends.

Key Terms

c-peptide, autoantibody, beta cell, mixed meal tolerance test, +3 more

7 terms

c-peptide medical

"Results demonstrated early signals of C-peptide preservation..."

C‑peptide is a short protein fragment released at the same time the pancreas produces insulin; because it lingers in the blood longer than insulin itself, clinicians measure C‑peptide levels as a clear sign of how much natural insulin a person still makes. For investors, C‑peptide matters because it’s used as a measurable outcome in diabetes drug and device trials, in diagnostic tests, and by regulators to judge treatment benefit — results that can affect clinical success, approvals, and market value.

autoantibody medical

"had residual beta cell function (C-peptide >0.2 nmol/L) and at least one T1D autoantibody at baseline."

An autoantibody is a protein made by the immune system that mistakenly targets a person’s own cells or proteins, like a security guard that starts attacking the building it’s meant to protect. For investors, autoantibodies matter because they can be used as diagnostic markers, indicate safety issues for drugs, influence clinical trial outcomes and regulatory decisions, and therefore affect the market value of diagnostics and therapeutics companies.

beta cell medical

"supporting a PD effect consistent with the preservation of beta cell function..."

Beta cells are specialized cells in the pancreas that act like a thermostat or factory for blood sugar by producing and releasing insulin, the hormone that helps the body store or use glucose. Investors watch beta cells because many diabetes treatments, diagnostics and biotech therapies aim to protect, replace or modify their function; progress or setbacks in that work can strongly affect the commercial value and regulatory prospects of related drugs and technologies.

mixed meal tolerance test medical

"MMTT = Mixed Meal Tolerance Test; AUC = Area Under the Curve; SEM = Standard Error..."

A mixed meal tolerance test measures how a person’s body handles a realistic, nutrient-containing meal by taking blood samples over several hours to track glucose, insulin and other metabolic markers. Investors care because it provides practical evidence of a drug, device or intervention’s effect on everyday metabolism and can be used as a regulatory or clinical endpoint that influences approval chances, market size and commercial value — similar to testing a car on real roads instead of just a lab bench.

area under the curve medical

"Figure 1: T1D Cohort – MMTT C-Peptide Mean AUC (nmoI/L) / Min ± SEM"

Area under the curve (AUC) is a measure of total exposure to a drug over time, calculated by summing the concentration of the drug in the blood at each point after dosing. For investors, AUC matters because it helps regulators and doctors judge how much of a medicine reaches the body and for how long—information that influences dosing, safety, regulatory approval, and ultimately a drug’s market potential, much like measuring total rainfall tells you how wet a season was.

standard error the mean medical

"MMTT = Mixed Meal Tolerance Test; AUC = Area Under the Curve; SEM = Standard Error the Mean."

A measure of how precisely an average calculated from a sample likely estimates the true population average; smaller values mean the sample average is likely closer to the real average. Think of it like the expected wobble in the result if you repeatedly took different small groups: it tells investors how much trust to place in reported averages (for returns, analyst estimates, survey results) and therefore how much uncertainty or risk surrounds decisions based on those averages.

phase 2b medical

"advance SAB-142 into the registrational Phase 2b SAFETY and Efficacy..."

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.

AI-generated analysis. Not financial advice.

Results demonstrated early signals of C-peptide preservation

T1D key opinion leader, Michael J. Haller, MD, provided a recorded webinar reviewing the SAB-142 Phase 1 data

MIAMI, March 10, 2026 (GLOBE NEWSWIRE) -- 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 announced additional data from the Phase 1 HUman anti-thymocyte biologic in first-in-MAN (HUMAN) clinical trial of SAB-142. The established T1D adult patient cohort demonstrated early signals of C-peptide preservation which aligned with the anticipated mechanism of action of SAB-142. In the T1D cohort (n=6), SAB-142 treated study participants (n=4) showed no decrease in C-peptide levels at Day 120 compared to baseline. The placebo study participant showed a decrease in C-peptide at Day 120 compared to the baseline.

“People living with T1D need novel treatment options to alter the course of their disease, and we know that the preservation of C-peptide as the marker of endogenous insulin production has a positive clinical effect for patients. While exploratory and early, the initial C-peptide data are encouraging and exactly the type of signal I hope to see at this stage. Additionally, these clinical observations were supported by biomarker evidence of T cell exhaustion consistent with prior studies, strengthening confidence that the therapy is engaging its intended biological mechanism,” said Michael J. Haller, M.D., Professor and Chief of Pediatric Endocrinology, University of Florida. “I am excited about SAB-142’s potential as a disease modifying therapy for T1D.”

The Phase 1 T1D cohort included six adult participants (n=6), with four receiving SAB-142 at 2.5 mg/kg (n=4) and two receiving placebo (n=2). Participants ranged in age from 19 to 40 years. All established T1D patients (Stage 3 T1D diagnosis within 28-40 months at the time of randomization) had residual beta cell function (C-peptide >0.2 nmol/L) and at least one T1D autoantibody at baseline. Phase 1 study exploratory efficacy endpoints were measured at the End of Study Day 120 post SAB-142 administration. One placebo participant (n=1) completed through Day 120 as the other placebo participant discontinued early due to personal reasons.

Participants treated with SAB-142 (2.5 mg/kg) demonstrated preservation in C-peptide levels compared to baseline with mean values increasing above baseline by Day 120. In contrast, the placebo-treated participant showed a decline in C-peptide consistent with the predicted rate of disease progression. For reference, the TN19 Placebo Cohort¹ is modeled using a historical C-peptide trajectory based on historical placebo arm from the TN19 study¹. By Day 120, participants receiving SAB-142 show divergence from both the study’s placebo-treated participant and the TN19 modeled placebo cohort, supporting a PD effect consistent with the preservation of beta cell function in adult patients with established T1D.

Figure 1: T1D Cohort – MMTT C-Peptide Mean AUC (nmoI/L) / Min ± SEM

_{Note: ¹ Predicted decline was estimated using placebo MMTT C-peptide AUC data from TN19 (n=31 at screening). Linear modeling of decline was based on Weeks 48, 72, and 96 (n=30, 26, and 26, respectively; post–2-hour values masked). A linear slope (–0.6108) was applied to estimate the rate of decline: AUC_BL – (–0.6108 × [Study Day/7]). Source: Haller et al. Diabetes. 2019 Jun;68(6):1267–1276.
MMTT = Mixed Meal Tolerance Test; AUC = Area Under the Curve; SEM = Standard Error the Mean.}

“We believe these Phase 1 data provide an opportunity to bring our early findings to investigators, clinicians, and patients, giving them greater visibility into the science behind SAB-142. By sharing this exploratory C-peptide trend openly, we aim to support informed engagement from the T1D community. While no statistical conclusions can be made, these findings align with our expectations and provide additional confidence as we clinically execute on SAFEGUARD, which is designed and powered to evaluate the safety and efficacy of SAB-142 for patients with new onset T1D,” said Samuel J. Reich, CEO, SAB BIO.

Previously, the Company announced the Phase 1 study met its primary objectives of establishing a safety profile and characterizing the PD activity for SAB-142. These results enabled SAB BIO to advance SAB-142 into the registrational Phase 2b SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes (SAFEGUARD) trial, which is evaluating SAB-142 in adult, adolescents, and pediatric patients with new-onset, Stage 3 T1D. The SAFEGUARD trial is enrolling and dosing participants at multiple sites around the world with topline data expected 2H 2027.

The Phase 1 data is available on the Company’s website in the SAB BIO Corporate Presentation, available in the Investors & Media section.

________________
_{¹ Haller MJ, Long SA, Blanchfield JL, et al; Type 1 Diabetes TrialNet ATG‑GCSF Study Group. Low‑Dose Anti‑Thymocyte Globulin Preserves C‑Peptide, Reduces HbA1c, and Increases Regulatory to Conventional T‑Cell Ratios in New‑Onset Type 1 Diabetes: Two‑Year Clinical Trial Data. Diabetes. 2019;68(6):1267‑1276. doi:10.2337/db19‑0057}

Webinar Details
T1D key opinion leader, Michael J. Haller, M.D., Professor and Chief of Pediatric Endocrinology, University of Florida, provided a recorded webinar reviewing the SAB-142 Phase 1 data, available at: SAB-142 Phase 1 Data in Adult Patients with Autoimmune T1D: Expert Perspective Webinar. The webinar is also available on the Events page of the Company’s website.

About the Phase 1 HUMAN Trial of SAB-142
The Phase 1 HUman anti-thymocyte biologic in first-in-MAN (HUMAN) clinical trial of SAB-142 is a randomized, double-blind, placebo-controlled, single-ascending dose and redose, adaptive design clinical study among healthy volunteers and one cohort of adult participants with established T1D. The study objectives include establishing safety, tolerability, pharmacokinetic (PK), immunogenicity, and pharmacodynamic (PD) profile for SAB-142 with a single 0.03-4.5mg/kg dose plus one cohort with an additional 1.5mg/kg dose.

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 or placebo 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) and at https://safeguardstudy.com/.

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. 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. 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.

Forward-Looking Statements
Certain statements made in this press 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, timing, 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
Investors:
Cristi Barnett
ir@sab.bio

Media:
Sheila Carlson
media@sab.bio

A figure accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ae23719c-8cb3-4ace-8649-929e852b9731

FAQ

What did SAB BIO (SABS) report about SAB-142 Phase 1 C-peptide results on March 10, 2026?

SAB BIO reported early signals of C‑peptide preservation at Day 120 in treated adults. According to the company, four SAB‑142–treated participants showed no decrease from baseline while the placebo participant declined, but results are exploratory and not statistically conclusive.

How many adult patients with T1D received SAB-142 in the Phase 1 cohort (SABS)?

The Phase 1 established T1D cohort included six adults total, four receiving SAB‑142 and two randomized to placebo. According to the company, participants were aged 19–40 with Stage 3 T1D and residual beta cell function at baseline.

What biomarkers supported SAB-142 activity in the Phase 1 T1D study (SABS)?

Biomarker data indicated evidence of T‑cell exhaustion consistent with the drug’s mechanism of action. According to the company, these PD biomarker signals aligned with the observed C‑peptide trends and prior study findings, supporting biological engagement.

When will SAB BIO (SABS) report topline results for the Phase 2b SAFEGUARD trial?

Topline data from the SAFEGUARD Phase 2b trial are expected in the second half of 2027. According to the company, SAFEGUARD is enrolling adult, adolescent, and pediatric new‑onset Stage 3 T1D patients globally to evaluate safety and efficacy.

What are the main limitations of the SAB-142 Phase 1 T1D findings for investors (SABS)?

Main limitations are the very small sample size and exploratory nature of the data, preventing statistical conclusions. According to the company, one placebo discontinued early and the results are intended to inform larger, powered SAFEGUARD trials rather than serve as definitive evidence.