Reported additional Phase 1 data for SAB-142 demonstrating C-peptide preservation and improvement in glycemic control in established autoimmune type 1 diabetes
Strong cash position, reflecting $95 million public offering proceeds, with operational runway through 2028 to support execution of SAFEGUARD and pre-commercial activities
Conference call today at 8:30 AM ET
MIAMI, May 12, 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 financial results for the first quarter ended March 31, 2026, and provided recent business highlights.
"The first quarter set a strong foundation for the year, as we executed according to plan across all fronts. I am encouraged to report that SAFEGUARD enrollment is progressing on schedule for completion by year-end. Our Phase 1 data demonstrate early C-peptide preservation and improved glycemic control with a favorable safety profile, and our recent public offering bolsters our financial runway through 2028 to support this program and pre-commercial activities," said Samuel J. Reich, Chief Executive Officer of SAB BIO. "This year we are focused on enrolling SAFEGUARD with Part A fully enrolled and Part B well underway and proceeding as planned. The pace of enrollment and enthusiasm from investigators underscores the urgent need within the diabetes community for therapies that go beyond insulin management to address the underlying autoimmune disease."
Recent Pipeline Achievements and Anticipated Milestones for SAB-142
Phase 2b SAFEGUARD study
Continued activation of multiple clinical trial sites in U.S., Australia, New Zealand, U.K. and European Union for SAFEGUARD (SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes) trial.
The SAFEGUARD trial will enroll a total of 159 Stage 3 T1D patients (ages 5-40), within 100 days of diagnosis.
Part A is a dose-ranging study in 12 adult T1D patients and has completed enrollment during the first quarter.
Part B is a randomized, double-blind, placebo-controlled, dose-ranging study and will enroll 147 pediatric, adolescent and adult T1D patients.
Part B was initiated during the first quarter.
The SAFEGUARD Study Data Monitoring Committee (DMC) recently approved the first stepdown to patients ages 12 and older.
SAFEGUARD is on track and expected to complete enrollment by end of 2026 as planned with topline data expected in 2H 2027.
The Company has received written correspondence from the FDA confirming that C-peptide area under the curve (AUC) may serve as a surrogate endpoint for accelerated approval. This communication represents a significant de-risking of our regulatory path to market.
Recent data presentation at 21st Immunology of Diabetes Society (IDS) Congress
As recently announced, SAB BIO presented additional clinical and mechanistic data from the Stage 3 T1D patients enrolled in the Phase 1 trial of SAB-142 (n=4 treated, n=2 placebo).
The results for SAB-142 highlighted C-peptide preservation, correlated with evidence of T cell exhaustion, which further validates ...
