SAB Biotherapeutics (NASDAQ:SABS) used an appearance at Oppenheimer’s 36th Annual Healthcare Life Sciences Conference to outline its strategy in type 1 diabetes (T1D), emphasizing development of a fully human anti-thymocyte globulin (ATG) designed to preserve pancreatic beta cell function in newly diagnosed patients.
Company focus and lead program
Chief Executive Officer Sam Reich said SAB’s mission is to “transform what it means to get a type 1 diabetes diagnosis” by developing a therapy intended to change the course of disease rather than manage symptoms. The company’s lead product candidate, SAB-142, is a human anti-thymocyte globulin being studied to immune modulate and promote self-tolerance in T1D patients to preserve beta cells.
He also highlighted SAB’s wholly owned “Tc Bovine” platform, which is used to make fully human immunoglobulin drugs. Reich said the platform provides multiple layers of intellectual property protection, including trade secrets, know-how, and patents. He added that the modality has “no biosimilar pathway,” which he said could provide long-term exclusivity for SAB-142.
How SAB-142 is intended to work
Reich explained that type 1 diabetes is an autoimmune disease in which patients develop autoantibodies that attack beta cells in the pancreas. He said a key therapeutic goal after diagnosis is preserving beta cells so patients can continue producing endogenous insulin.
According to Reich, SAB-142 is designed to induce T-cell exhaustion while preserving regulatory T cells (Tregs), a mechanism he said has been associated with preserving beta cells and improving glycemic function. He pointed to historical clinical work with Thymoglobulin, a rabbit-derived anti-thymocyte globulin, as reference evidence for this mechanism. Reich said prior studies of rabbit ATG in newly diagnosed T1D patients demonstrated beta cell preservation versus placebo and reduced HbA1c versus placebo.
Differences versus rabbit ATG: redosing and tolerability
Reich contrasted SAB-142 with rabbit ATG, arguing the rabbit-derived product has “two liabilities” for chronic disease use: serum sickness and the inability to redose due to anti-drug antibodies and safety risk. He said SAB-142, as a human polyclonal antibody, has already been shown not to cause serum sickness and to be redosable.
He also listed three specific differences between rabbit and human ATG:
- Serum sickness: Reich said rabbit ATG can cause delayed serum sickness about a week after dosing, which is difficult to manage and could worsen upon redosing.
- Immunogenicity and anti-drug antibodies: He said most patients develop anti-drug antibodies to rabbit ATG, limiting repeat dosing for both safety and efficacy reasons.
- Lymphodepletion via ADCC: Reich said the rabbit Fc region can drive antibody-dependent cell killing (ADCC), leading to depletion of immune cells such as lymphocytes and potentially compromising immunity—an issue he said is undesirable for chronic use, young patients, or otherwise healthy patients.
By contrast, Reich said SAB-142’s human Fc profile does not lead to the same ADCC-driven lymphodepletion, and he described the goal as preserving immune competence while enabling chronic use.
SAFEGUARD Phase IIb: design, endpoints, and timing
Reich said SAB-142 is being evaluated in SAFEGUARD, a global Phase IIb study in newly diagnosed Stage 3 type 1 diabetes patients within 100 days of diagnosis. Enrollment includes patients ages five to 40, spanning pediatric, adolescent, and adult groups.
The trial has three arms—2.5 mg/kg, 1.5 mg/kg, and placebo—with dosing every six months. The study is stratified by age to achieve relatively even distribution across age groups.
The primary endpoint is C-peptide at one year. Reich described C-peptide as a validated endpoint reflecting beta cell mass and/or function, and said preserving C-peptide is the objective for newly diagnosed patients. He stated that a clinically meaningful preservation is “generally considered to be 40% preservation compared to placebo.”
He also listed secondary measures of interest to clinicians and investors, including HbA1c, insulin use, frequency of hypoglycemic events, and continuous glucose monitoring metrics such as Time in Range.
On timing, Reich said the company is on track to have the last patient in by the end of 2026 and to report top-line data in the second half of 2027.
Regulatory positioning, commercial planning, and financial runway
Reich said SAB has agreement with the FDA that SAFEGUARD is a pivotal study and described it as “registrational,” effectively a de facto Phase III based on powering, endpoints, and patient population. He said the company believes the study will be sufficient for approval based on precedent and its experience, while noting there is time before a potential biologics license application to augment the program if the FDA requires additional exposure.
Reich also discussed the evolving T1D landscape, including Sanofi’s filing of an SBLA for Stage 3 type 1 diabetes for Tzield. He suggested that if the FDA accepts C-peptide as sufficient for approval in that setting, it could further support the regulatory path for disease-modifying therapies.
On commercial opportunity, Reich cited 64,000 new U.S. diagnoses per year for Stage 3 as the initial addressable market and said redosing could expand the commercial opportunity over time as patients accumulate. He said the company intends to study SAB-142 in Stage 2 in a future Phase II program, though he characterized the incremental market sizing as difficult to quantify today given current diagnosis patterns.
Reich said pricing discussions are early, but pointed to Tzield’s cited price of $200,000 as a guidepost. He also said SAB is preparing for potential commercialization by mapping the patient-provider journey and willingness to pay, assessing where patients are diagnosed, and planning early messaging and a potentially small commercial footprint due to treatment concentration at institutions.
Regarding finances, Reich said SAB ended 2025 with $140 million in cash and that its runway fully funds SAFEGUARD through top-line data plus roughly one additional year, providing cash into 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.
