SAB Biotherapeutics Q2 Earnings Call Highlights

Key Points

• SAFEGUARD remains on schedule: SAB Biotherapeutics expects to complete enrollment in its Phase IIb trial of SAB-142 in the fourth quarter of 2026, with top-line results anticipated in the second half of 2027. More than 60 sites are recruiting, and the study is expanding to younger patients.
• PRISE will broaden the potential treatment population: The investigator-led Phase III study is expected to begin enrolling in the second half of 2026 and will evaluate patients diagnosed 100 days to two years earlier, with results projected for the first quarter of 2029.
• Cash runway extends through 2028: SAB ended the quarter with $208 million in cash and investments, despite a net loss of $22.5 million. The company also began construction of a second South Dakota farm facility to provide manufacturing redundancy and support potential commercial supply.

SAB Biotherapeutics NASDAQ: SABS said its registrational Phase IIb SAFEGUARD trial of SAB-142 in newly diagnosed Stage 3 Type 1 diabetes remains on track to complete enrollment in the fourth quarter of 2026, with top-line data expected in the second half of 2027.

Chief Executive Officer Samuel Reich said more than 60 clinical sites are actively recruiting for the study, supporting growth in patient screening and randomization. Part A enrollment was completed during the prior quarter, while Part B is continuing to enroll. The company has also received approval for the first step-down to adolescents aged 12 and older and expects to step down to patients age 5 and above during the current quarter.

SAB-142 is a fully human anti-thymocyte immunoglobulin designed to preserve insulin-producing beta cells and potentially slow disease progression in autoimmune Type 1 diabetes. The company produces the candidate using its Tc Bovine platform, which it said can generate fully human multispecific antibodies without human donors.

SAFEGUARD Enrollment and Clinical Strategy

Reich said the increase in SAFEGUARD enrollment has primarily been driven by the activation of additional clinical sites. The company is evaluating patients ages 5 to 40 who are within 100 days of a Stage 3 Type 1 diabetes diagnosis.

Chief Medical Officer Alexandra Kropotova said the SAFEGUARD protocol requires at least 36 patients ages 5 to 11, with two-thirds of the overall population below age 18. The trial also caps adult enrollment at 45 patients. She said the baseline characteristics of enrolled patients have been in line with the company’s protocol expectations.

Kropotova noted that SAFEGUARD differs from the company’s Phase I trial in the timing of enrollment. SAFEGUARD enrolls patients within 100 days of disease onset, while patients in the Phase I study were beyond 100 days from diagnosis. Both populations require preserved C-peptide levels of at least 0.2 nanomoles per liter.

Management did not disclose SAFEGUARD screening-failure rates. Reich said the company has sufficient drug supply to support both the SAFEGUARD and PRISE studies.

PRISE Study Targets Broader Population

The company also discussed PRISE-hATG, an investigator-led Phase III study supported by a grant from Breakthrough T1D to Michael Haller, professor and chief of pediatric endocrinology at the University of Florida. SAB is co-funding the study, which will evaluate SAB-142 in patients with Stage 3 Type 1 diabetes who are 100 days to two years from diagnosis.

Reich said PRISE is intended to address patients who remain capable of producing insulin but are outside the diagnosis window used in other protocols. He said the study is expected to begin enrolling during the second half of 2026.

Kropotova said PRISE has seven sites, including four in the United States and three in Europe. While the study will begin after SAFEGUARD, she said top-line PRISE results are expected in the first quarter of 2029. The trial is designed to be adequately powered to detect a difference between active treatment and placebo on its primary endpoint, C-peptide at 12 months following a two-hour mixed-meal tolerance test. It is also powered for a key secondary endpoint related to glycemic control.

According to Kropotova, the PRISE and SAFEGUARD inclusion and exclusion criteria are otherwise identical aside from the time since disease onset. She said the company does not expect PRISE participants to necessarily have lower baseline C-peptide levels, citing data indicating C-peptide can remain preserved for years after diagnosis.

Reich said data from PRISE would follow SAFEGUARD and could potentially support a supplemental biologics license application for a label expansion covering patients up to two years after diagnosis, if the study is successful.

Tzield Approval and Competitive Context

Reich said the recent FDA approval of Tzield for children and adolescents recently diagnosed with Stage 3 Type 1 diabetes was positive for the Type 1 diabetes community and for SAB’s development program. He said the approval reinforces the role of early disease-modifying intervention and provides precedent for C-peptide as a basis for accelerated approval in Type 1 diabetes.

Management said it was too soon to draw conclusions from Tzield’s Stage 3 launch. Reich noted that the majority of SAFEGUARD sites are in Europe and said Tzield’s approved label is limited to U.S. patients ages 8 to 17 within eight weeks of diagnosis, compared with SAFEGUARD’s population of patients ages 5 to 40 within 100 days of diagnosis.

Reich said SAB believes SAB-142 could offer efficacy, safety and dosing advantages, citing its potential for redosing due to low-to-no immunogenicity and a two-day dosing schedule compared with Tzield’s 12-day regimen.

Financial Results and Manufacturing Investment

Chief Financial Officer Lucy To said SAB ended the second quarter with $208 million in cash equivalents and investment securities as of June 30, 2026. The company said it expects its cash runway to extend through 2028.

• Research and development expense was $16.2 million, compared with $7 million in the second quarter of 2025, reflecting clinical trial costs and headcount supporting SAFEGUARD.
• General and administrative expense was $7.2 million, compared with $2.7 million a year earlier, due to higher headcount costs and stock-based compensation.
• Other income was $0.9 million, compared with an expense of $0.4 million in the prior-year period, driven primarily by higher interest and dividend income.
• Net loss was $22.5 million, compared with $10.1 million in the second quarter of 2025.

Beyond clinical development, Reich said the company began construction of a second farm facility in South Dakota during the quarter. The facility is intended to establish a redundant herd, reduce operational risk and support potential long-term commercial supply of SAB-142.

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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