SAB Biotherapeutics (NASDAQ:SABS) reaffirmed its timeline for completing enrollment in its pivotal Type 1 diabetes study by the end of 2026, as the company reported a wider research spending bill and a third-quarter net loss.
Chief Executive Officer Samuel Reich said the adult and adolescent groups in the Phase IIb SAFEGUARD trial of SAB-142 are fully enrolled and closed for screening. The company expects top-line results in the second half of 2027.
In September, an independent data monitoring committee approved the trial’s final age step-down to children ages 5 to 11. Reich said pediatric screening and enrollment were progressing in line with the company’s expectations.
Two Studies Target Different Stages of Diagnosis
SAB-142 is an experimental, fully human anti-thymocyte immunoglobulin designed to preserve insulin-producing beta cells and slow the progression of autoimmune Type 1 diabetes. SAFEGUARD is studying the treatment in people newly diagnosed with Stage 3 disease.
Chief Medical Officer Alexandra Kropotova said the trial’s primary endpoint measures preservation of beta-cell function using C-peptide. The company also plans to report measures of glycemic control, including HbA1c and continuous glucose monitoring, along with immunogenicity and safety data associated with long-term redosing.
Kropotova said the independent monitoring committee reviewed unblinded, cumulative safety data by treatment arm and age group. She said no new safety signal had been identified in SAFEGUARD and that the observed safety profile had been consistent across age groups.
Reich said the company had not disclosed how many patients had been redosed, but that redosing was proceeding according to plan. Asked about longer-term follow-up from four patients in a Phase I study, he said the study ended at 120 days and the company had not collected data beyond that point.
A separate investigator-led Phase III study, called PRISE, is expected to dose its first patient in the fourth quarter. The study is designed to assess SAB-142 in patients up to two years after a Stage 3 diagnosis, with seven sites planned across the U.S., Europe and the U.K.
Reich said PRISE includes groups diagnosed within 100 days, between 100 and 365 days, and between one and two years before enrollment. The company hopes the study could support an eventual expansion of the patient population eligible for treatment, depending on its results.
SAB has not provided a specific timeline for PRISE data. Reich said he expects results after those from SAFEGUARD, though the timing remains uncertain because PRISE is investigator-led. Breakthrough T1D supports the study through a grant, and SAB co-funds it.
Fast Track Designation and Treatment Outlook
The Food and Drug Administration granted SAB-142 Fast Track designation in October for the treatment of new-onset Stage 3 Type 1 diabetes. The designation can provide more frequent interactions with the agency and eligibility for a rolling review of a future biologics license application. Priority Review is also possible if applicable criteria are met.
Reich cautioned that Fast Track designation does not change the FDA’s approval standards or guarantee approval.
Asked about the outlook for SAB-142 alongside TZIELD, Reich said he was encouraged by uptake of the existing treatment and believed it was establishing a pattern of treatment among doctors and patients. He said SAB-142 could offer fewer days of dosing, while acknowledging that its efficacy results remain to be seen.
Cash Runway and Quarterly Results
Chief Financial Officer Lucy To said SAB ended September with $205 million in cash, equivalents and investment securities and expects its existing cash balance to fund operations through 2028. The total included $13.4 million in gross proceeds received during the quarter from warrant exercises associated with a July 2025 private investment.
Research and development expenses rose to $18.1 million from $9 million a year earlier, primarily because of clinical trial costs and related staffing for SAFEGUARD. General and administrative expenses increased to $7.8 million from $3.7 million, driven mainly by personnel costs, including stock-based compensation.
The company reported a net loss of $22.3 million, compared with net income of $45.4 million a year earlier. Other income fell to $3.6 million from $58.1 million, a decline To attributed primarily to the change in fair value of warrant liabilities recognized in 2025.
Reich said PRISE expenses were already included in the company’s budgeting and did not change its projected cash burn.
About SAB Biotherapeutics (NASDAQ:SABS)
SAB Biotherapeutics, Inc is a biotechnology company focused on developing fully human polyclonal antibody medicines for infectious diseases, immune disorders and other conditions where targeted immune responses may provide therapeutic benefits. The company is based in Sioux Falls, South Dakota.
SAB Biotherapeutics uses its DiversitAb platform, which involves genetically engineered cattle capable of producing antibodies with human immune-system characteristics. Antibodies are collected from the animals’ plasma and processed for potential use as treatments, allowing the company to pursue antibody products without relying solely on conventional human donor sources.
The company has developed a pipeline that has included SAB-185, an investigational antibody therapy directed at SARS-CoV-2, as well as programs targeting influenza and autoimmune or immune-mediated diseases.
