SAB Biotherapeutics (NASDAQ:SABS) used a presentation at Guggenheim’s Emerging Outlook Biotech Summit 2026 to outline its strategy in type 1 diabetes (T1D), focusing on a pivotal Phase 2b program for its lead candidate SAB-142. CEO Sam Reich said the company’s mission is to “transform what it means to get a Type 1 Diabetes diagnosis” by developing therapies that change the course of the disease rather than only managing symptoms.
Focus on newly diagnosed stage 3 type 1 diabetes
Reich described T1D as an autoimmune condition in which autoantibodies attack pancreatic beta cells that produce insulin. He said there are about 64,000 new patients diagnosed each year. SAB is initially targeting stage 3 T1D, which he characterized as the point when patients have lost enough beta cells that they require exogenous insulin.
SAB-142 mechanism and rationale versus rabbit ATG
SAB-142 is a fully human anti-thymocyte immunoglobulin (ATG). Reich said ATG is a T-cell engaging modality that binds and activates T-cells, leading to T-cell exhaustion—an effect he linked to self-tolerance and efficacy. He also emphasized that SAB-142 is intended to induce T-cell exhaustion while preserving regulatory T-cells (Tregs), which he said are important for self-tolerance.
Reich pointed to clinical precedent with rabbit ATG (Thymoglobulin, a Sanofi product approved for organ transplant) that has been evaluated in T1D. He referenced the START study, which he said did not work due to too high a dose, and then cited later lower-dose studies that he said demonstrated beta cell preservation:
- TN19 (2018) and MELD-ATG (published in The Lancet in September), which he said showed preservation of C-peptide and improved glycemic control, including a statistically significant reduction in HbA1c versus placebo.
However, Reich argued that rabbit ATG has limitations that prevent an acceptable commercial profile in T1D. He said Thymoglobulin is a foreign protein that can cause serum sickness—described as rashes, fever, and flu-like symptoms lasting multiple days—and that it cannot be redosed due to serum sickness and immunogenicity leading to anti-drug antibodies. Reich positioned SAB-142’s fully human profile as addressing these issues, saying it does not cause serum sickness, does not lead to anti-drug antibodies, and can be redosed for chronic therapy.
Phase 1 takeaways and dosing selection
Reich said SAB-142’s Phase 1 first-in-human study was completed in 2024 with data announced in early 2025. The trial included mostly adult healthy volunteers plus a cohort of T1D patients, and it tested escalating doses up to 4.5 mg/kg (higher than the doses being used in the Phase 2b study). He said the Phase 1 included a redosing cohort and had objectives to show:
- no serum sickness,
- no anti-drug antibodies, and
- a mechanism of action consistent with Thymoglobulin.
Reich said those objectives were met, and that dose selection for the pivotal program focused on identifying doses that initiated “durable T-cell exhaustion.” He said the two doses selected for the pivotal study are 2.5 mg/kg and 1.5 mg/kg. He also noted that while 2.5 mg/kg rabbit ATG has shown efficacy in two studies, the MELD trial evaluated lower doses down to 0.5 mg/kg; Reich said SAB’s objective is to identify an “optimal dose,” and cautioned that dosing is not one-to-one between rabbit ATG and SAB-142.
SAFEGUARD pivotal study design and timeline
Reich described SAFEGUARD as a global study in newly diagnosed T1D patients within 100 days of diagnosis, enrolling patients ages five to 40. The trial plans to enroll 159 patients across three arms (2.5 mg/kg, 1.5 mg/kg, and placebo), and is being conducted in the U.S., U.K., Europe, and Australia.
The primary endpoint is C-peptide at one year, and Reich said HbA1c is a key secondary endpoint. He also explained that the study is split into two parts:
- Part A: 12 adults (six per active dose) that are “sequestered” outside the efficacy analysis to enable an age step-down plan without disrupting stratification.
- Part B: the efficacy population used for statistical analysis, with enrollment stratified approximately one-third adults, one-third adolescents, and one-third pediatrics.
On the inclusion of younger children, Reich said the company has a step-down plan discussed with regulators, starting with adults before enrolling adolescents and then pediatric patients, with tolerability established in older groups before moving to younger ages.
For timing, Reich said the company expects to complete enrollment by the end of 2026 and anticipates data in the second half of 2027, reflecting the one-year primary endpoint.
Reich said the study is powered at 80% to show 40% preservation of C-peptide, which he described as clinically meaningful. He also said, based on MELD and TN19, the trial has roughly similar power to detect a 0.5 absolute reduction in HbA1c. He characterized success as achieving clinically meaningful C-peptide preservation, while stating the company also hopes to show an HbA1c benefit consistent with prior rabbit ATG studies.
Commercial preparation, competition, and financial position
Reich said commercial work is in early stages but underway, including efforts to understand the patient, payer, and provider journey. He also clarified a leadership update: SAB recently appointed David Zaccardelli as chairman (Reich said he is no longer chairman), noting Zaccardelli’s experience launching Ohtuvayre at Verona.
On expansion opportunities, Reich said SAB intends to pursue stage 2 T1D next, which he described as a “holy grail” opportunity where preserving beta cell function could potentially keep patients insulin-free. He also said the company is interested in expanding beyond the initial “within 100 days of diagnosis” label to include patients later than 100 days post-diagnosis who still have meaningful C-peptide to preserve.
On the competitive landscape, Reich cited a read-through from the Tzield PROTECT study in stage 3 and a commissioner’s priority voucher intended for a stage 3 approval, saying it would represent regulatory clarity and a path in which C-peptide benefit could be sufficient for approval. He also noted that in PROTECT, benefit was shown on C-peptide but not on secondary endpoints.
Regarding finances, Reich said the company burned about $40 million last year and ended 2025 with $140 million in cash. He said SAB has cash sufficient through the pivotal trial, with runway past data, and expects cash to last through 2028.
About SAB Biotherapeutics (NASDAQ:SABS)
SAB Biotherapeutics, Inc is a clinical-stage biotechnology company headquartered in Sioux Falls, South Dakota, that focuses on developing fully human polyclonal antibody therapeutics. The company’s proprietary platform, known as Tc Bovine®, uses genetically engineered cattle to generate large quantities of human antibodies tailored to target specific infectious agents or disease-related antigens. This approach is designed to combine the broad-spectrum coverage of polyclonal antibody therapies with the scalability and consistency required for clinical development and commercial use.
The company’s lead programs are directed primarily at infectious diseases.
