SAB Biotherapeutics Q1 Earnings Call Highlights

Key Points

• SAB-142, SAB Biotherapeutics’ lead type 1 diabetes candidate, remains on track in the SAFEGUARD Phase 2b trial, with enrollment progressing as planned and top-line data still expected in the second half of 2027.
• The company said the FDA correspondence supports C-peptide as a surrogate endpoint for accelerated approval, which management described as a meaningful de-risking of its regulatory path.
• SAB Biotherapeutics highlighted early Phase 1 data showing potential clinical benefit, including C-peptide preservation and improved time-in-range glucose control, while emphasizing SAB-142’s potential for repeat dosing and chronic treatment use.

SAB Biotherapeutics NASDAQ: SABS said its lead type 1 diabetes candidate, SAB-142, remains on track in a registrational Phase 2b trial, as the clinical-stage biopharmaceutical company reported a wider first-quarter loss alongside higher research and development spending.

Chief Executive Officer Samuel Reich told investors on the company’s first earnings call that SAB BIO is focused on developing fully human anti-thymocyte immunoglobulin for type 1 diabetes and other autoimmune diseases. The company’s lead product candidate, SAB-142, is being developed as a potentially disease-modifying, re-dosable immunotherapy for autoimmune type 1 diabetes.

“Our mission is to dramatically redefine what it means to be diagnosed with type 1 diabetes by developing a medicine to change the course of disease, not just treat the symptoms,” Reich said.

SAFEGUARD Enrollment Remains on Track

Reich said enrollment in the company’s SAFEGUARD trial is progressing on schedule and remains on track for completion by the end of 2026, with top-line data expected in the second half of 2027. The trial is enrolling patients across the U.S., Australia, New Zealand, the U.K. and the European Union.

SAFEGUARD is designed to enroll 159 Stage 3 type 1 diabetes patients between the ages of five and 40, all within 100 days of diagnosis. The study includes two parts:

• Part A, a dose-ranging study in 12 adult patients, completed enrollment during the first quarter.
• Part B, a randomized, double-blind, placebo-controlled study enrolling 147 pediatric, adolescent and adult patients, began in the first quarter and is actively enrolling.

Reich said the study data monitoring committee recently approved the first age step-down to enroll patients ages 12 and older. In response to an analyst question, he said the committee’s decision was based on Part A safety data up to four weeks from randomization in the 12 patients. He added that the company expects to step down to patients five and older “in the coming months,” depending on further safety review.

Reich said SAB BIO expects at least 20% of SAFEGUARD patients to be enrolled in the U.S., about 60% in Europe and the U.K., and the remainder in Australia, based on the company’s site footprint and enrollment trends to date.

FDA Correspondence Supports C-Peptide Endpoint

The company said it received written correspondence from the U.S. Food and Drug Administration confirming that C-peptide may serve as a surrogate endpoint for accelerated approval. Reich described the correspondence as “a meaningful de-risking” of SAB BIO’s regulatory path.

During the question-and-answer portion of the call, Reich said the company developed SAFEGUARD and its broader clinical regulatory plan through correspondence with the FDA and believes it has alignment with the agency. He said the company is not disclosing detailed feedback from other regulators but characterized feedback across agencies as consistent.

Asked whether SAB BIO would pursue accelerated approval outside the U.S., Reich said it was too early to say, but added that the company plans to seek approval globally, with the U.S. as its priority.

Phase 1 Data Highlighted at Diabetes Immunology Meeting

Reich also reviewed new findings from SAB-142’s Phase 1 study that were presented at the Immunology of Diabetes Society Congress. He said the data highlighted the candidate’s mechanism of action and suggested that the mechanism translated into clinical benefit for people with type 1 diabetes.

According to Reich, Phase 1 data showed preservation of C-peptide levels correlated with evidence of T-cell exhaustion. Of four SAB-142-treated participants, three showed what he called a “super responder profile,” with C-peptide levels at or above baseline at day 120. Treated participants also showed improved glycemic control, with mean time in range increasing from 73% at baseline to 85% at day 120, without an associated increase in exogenous insulin use.

Reich cautioned that the results were early and exploratory but said they further support the company’s confidence in SAFEGUARD. Asked whether similar increases in C-peptide could be shown in SAFEGUARD, he said the company’s goal in the larger trial is preservation of C-peptide.

“When we look at a larger group of patients over a longer period of time, the goal is to show preservation,” Reich said. “We’ll certainly be very happy if patients at one year have their C-peptide the same as it was when they started.”

Reich also said the Phase 1 patients had more mature disease, having had type 1 diabetes for two years or more. He said the results provide support for potential development in more established type 1 diabetes, which the company intends to pursue.

Company Emphasizes Differentiation and Repeat Dosing

Responding to a question about how SAB-142 differs from CD3 antibodies, Reich said anti-CD3 antibodies are monoclonal and have a singular effect on one target, while SAB-142 is polyclonal and binds multiple targets across T cells. He said SAB-142 is designed to induce T-cell exhaustion at a low dose while preserving or possibly activating regulatory T cells.

Reich said a key advantage of SAB-142 is its lack of immunogenicity and serum sickness observed in Phase 1, which he said supports the potential for repeat dosing. He contrasted that with rabbit anti-thymocyte globulin and Tzield, saying SAB-142 may be able to be dosed chronically to maintain T-cell exhaustion and preserve beta cells.

Asked about repeat dosing in a potential pivotal program and FDA application, Reich said patients in SAFEGUARD receive at least two doses, and a long-term extension study allows patients who complete their 12-month visit and still have C-peptide to continue and receive four doses. He said the company hopes the resulting data will support chronic dosing in the label.

Cash Position Supports Runway Through 2028

Chief Financial Officer Lucy To said SAB BIO ended the first quarter with $217.6 million in cash, cash equivalents and available-for-sale securities as of March 31, 2026. She said that position provides an operational runway through 2028 and fully supports execution of SAFEGUARD and pre-commercial activities.

The company completed a public offering in March, and following the underwriters’ exercise of the overallotment option, aggregate gross proceeds totaled approximately $95 million.

Research and development expenses rose to $13.4 million in the first quarter of 2026 from $7.7 million in the same period of 2025. To said the increase was driven by investments in the SAB-142 program, including site activation and patient enrollment in SAFEGUARD.

General and administrative expenses were $6.6 million, compared with $3.1 million a year earlier. To attributed the increase primarily to higher non-cash stock-based compensation and personnel-related costs tied to the company’s expanded team.

Other income declined to $1.1 million from $5.6 million, driven by changes in the fair value of warrant liabilities. Net loss widened to $18.9 million from $5.2 million in the prior-year period.

On the manufacturing front, Reich said SAB BIO executed a multi-year agreement on April 29 with Emergent BioSolutions to support process development and clinical and commercial manufacturing of SAB-142 in anticipation of regulatory approval. Asked about the scale of the agreement, Reich said the company has not disclosed a specific number of doses but expects the Emergent arrangement to support supply for a potential launch.

“Our plan with Emergent does have us ready when we launch to have a strong launch and have more than enough drug supply to supply the demand,” Reich said.

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.

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