SAB Biotherapeutics (SABS) Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

Mission and lead asset

• Focused on transforming type 1 diabetes treatment by developing a disease-modifying therapy, not just symptom management.

• Lead product SAB-142 is a fully human anti-thymocyte globulin designed to preserve beta cells and improve glycemic control.

• SAB-142 is produced using a proprietary Tc Bovine platform, offering strong intellectual property protection and no biosimilar pathway.

• Currently in a global Phase IIb pivotal trial (SAFEGUARD) for newly diagnosed Stage 3 type 1 diabetes.

• Type 1 diabetes represents a multi-billion dollar market opportunity with significant unmet medical need.

Clinical differentiation and mechanism

• SAB-142 induces T-cell exhaustion while preserving Tregs, validated by prior rabbit ATG studies but with improved safety.

• Unlike rabbit ATG, SAB-142 does not cause serum sickness, can be redosed, and avoids lymphodepletion, making it suitable for chronic use.

• Human Fc receptor in SAB-142 prevents antibody-dependent cell killing, maintaining immune competence.

• Lower dosing, as learned from MELD and TN19 trials, maintains efficacy while reducing safety risks.

• Mechanism of action is supported by robust clinical data, reducing development risk.

SAFEGUARD trial design and regulatory pathway

• Enrolling newly diagnosed Stage 3 patients aged 5–40, with three arms (two dosing levels and placebo), dosed every six months.

• Primary endpoint is C-peptide preservation at one year; secondary endpoints include HbA1c, insulin use, hypoglycemic events, and Time in Range.

• Full enrollment expected by end of 2026, with top-line data in the second half of 2027.

• FDA has agreed SAFEGUARD is a pivotal, registrational-intent study; additional supportive studies may be added if needed.

• Ongoing updates and Phase I data presentations planned for 2026.