SAB Biotherapeutics’ Earnings Call: PRIZE/PRISE Trial Confusion, Data Timelines, and Site Counts Don’t Align

Date of Call: Aug 6, 2026

Business Commentary:

Clinical Trial Enrollment and Progress:

• SAB Bio reported that over 60 clinical sites are actively recruiting for the Safeguard trial, with steady growth in both screening and randomization.
• The enrollment acceleration is primarily due to the activation of additional clinical sites and increased engagement from investigators and patients.

Financial Position and Expenses:

• The company ended the quarter with $208 million in cash and investment securities, providing an operational runway through 2028.
• R&D expenses increased to $16.2 million for Q2 2026 from $7 million in Q2 2025, driven by ongoing clinical trial costs and related headcount.

Breakthrough T1D Grant and Prize Study:

• Breakthrough T1D awarded a grant to support the Prize study, evaluating SAB 142 in patients with recent and extended onset stage 3 type 1 diabetes.
• This external support validates SAB Bio's approach and addresses a significant unmet need for treating patients beyond the initial 100-day diagnosis window.

Regulatory Milestones and Competitive Landscape:

• The recent FDA approval of T-Zield for children and adolescents with stage 3 type 1 diabetes reinforces the value of early disease-modifying intervention.
• This approval provides a regulatory precedent for C-peptide as a sufficient marker for accelerated approval, benefiting the broader field including SAB Bio.

Sentiment Analysis:

Overall Tone: Positive

• We are pleased to have you with us today to share the progress we've made in the second quarter. We remain focused on execution, delivering meaningful progress... We are well capitalized to support, safeguard, and thrive through key milestones... The recent FDA approval... is an important milestone... We're encouraged by the pace of enrollment... We are excited about what lies ahead.

Q&A:

• Question from UBS / Barclays: As it pertains to the data from Safeguard and then Prize, could you maybe talk a little bit about the rationale behind the labeling strategy here and also the plan sequencing and timing of the filings?
  Response: The Prize study extends the patient population beyond 100 days from diagnosis to address unmet need; data would come later via an SBLA to expand the label.

• Question from UBS / Barclays: Could you just walk us through maybe the timelines for that prize study in this expanded population? And then... just relative to the opportunity in those patients under 100 days, how much larger could this expanded cohort be and what would good data look like...?
  Response: Prize enrollment expected to start in second half of 2026; the opportunity is larger as patients have more time to decide; data should be quite similar to the initial population.

• Question from Jeffries: Can you tell us more about what drove the acceleration of recruitment for your phase two? And then... can you just speak to more about the package or the data that convinced the FDA to allow you to start the phase three study?
  Response: Increased recruitment driven by more active clinical sites. The phase three (Prize) study was allowed based on phase one data showing excellent safety and early evidence of efficacy.

• Question from Leerink Partners: I was just wondering if you could elaborate a bit on your thoughts regarding the recent FDA approval for T-Zield... and how you think this potentially impacts the regulatory bar for success from the Safeguard program... And then... wondering if you're able to comment at all on how the baseline characteristics of patients entering Part B are tracking versus your internal expectations...?
  Response: T-Zield's approval is great news, confirms C-peptide is sufficient for accelerated approval, and helps drive market awareness. Baseline characteristics in Safeguard Part B are tracking in line with protocol expectations.

• Question from Citi: Can you talk about the population you're enrolling in the prize study and how it compares to Safeguard? Other than the time since diagnosis, how similar are these populations and should we expect them to have less beta cell function or is that not always the case?
  Response: Outside of time from diagnosis, inclusion criteria are identical; baseline C-peptide levels are not expected to be lower, consistent with epidemiological data showing preservation for years.

• Question from Chardan: Just kind of a follow-up on the FDA action on the expanded label for T-SHIELD. Just wondering, since that's occurred, are you seeing maybe more inbound interest from investigators in your study?
  Response: Not noted a direct increase in interest, but T-Zield's U.S. approval is limited to Stage 3; some U.S. patients have enrolled in Safeguard due to SAB 142's dosing profile.

• Question from Rodman and Renshaw: Can you update us on the timing and status of the step-down to patient five and above?
  Response: Step down to pediatric patients (age 5+) anticipated this quarter; full enrollment on track for Q4.

• Question from Rodman and Renshaw: How is the price HADG study powered?
  Response: It is adequately powered (80% for at least 40% difference on C-peptide) to detect primary endpoint difference between active and placebo.

• Question from HC Wainwright: Have you commented on how many sites you're expecting to be included in the prize study?... And then secondly, with the TZIELD approval now in stage three, are there any aspects of the TZIELD launch that you're tracking...?
  Response: Prize study has 7 sites (4 U.S., others in Europe); starts staggered vs. Safeguard with top-line data expected in Q1 2029. Will monitor T-Zield's launch but too early for conclusions.

• Question from Brookline Capital Markets: Given that for the price study planning 7 site, how do you think you'll be able to enroll so quickly?... And in terms of drug supply, where do you stand with regard to that?
  Response: High demand from patient community beyond 100 days allows efficient enrollment over fewer sites. Sufficient supply for both trials.

Contradiction Point 1

Trial Naming and Data Timeline

Different trial names and conflicting data timelines for the PRIZE/PRISE study.

What were the key takeaways from UBS and Barclays earnings calls? - UBS / Barclays

2026Q2: The PRIZE study extends the patient population... A Supplemental Biologics License Application (sBLA) is planned for PRIZE to potentially expand the label. - Samuel Reich(CEO)

Can you explain the rationale behind the labeling strategy for Safeguard and Prize data, as well as the sequencing and timing of the filings? - Roy (UBS)

2026Q2: The PRISE trial extends the patient population... The data from PRISE, expected later, would support an sBLA... - Samuel Reich(CEO)

Contradiction Point 2

Trial Site Count and Enrollment Timeline

Inconsistent information on the number of clinical sites and enrollment start date for the PRIZE/PRISE study.

HC Wainwright - HC Wainwright

2026Q2: The PRIZE study has 7 sites total (4 in the U.S., others in Europe). Enrollment starts staggered vs. Safeguard, with top-line data planned for Q1 2029. - Alexander Kropotkova(CMO)

Can you provide the expected number of sites for the prize study and clarify if the enrollment cadence will be similar to the safeguard study? - UBS / Barclays

2026Q2: PRIZE enrollment is expected to start in the second half of 2026. - Samuel Reich(CEO)

Contradiction Point 3

PRIZE Study Top-Line Data Timeline

Inconsistent guidance on when top-line data for the PRIZE study will be available.

What was Rodman and Renshaw's analysis of the earnings call? - Rodman and Renshaw

2026Q2: The guidance for top-line data in the second half of 2027 remains unchanged as long as enrollment completion is on track for Q4 2026. - Samuel Reich(CEO)

Can you update us on the timing and status of the step-down to patient five and above, and how confident are you in delivering the top-line data in Q4 considering the Part B full enrollment in Q4, site activation, and last patient in timelines? - Thomas Smith (Layering Partners)

2026Q1: The recent written correspondence is a confirmation that C-peptide is a sufficient endpoint for accelerated approval. The company continues to have full alignment and confidence in its regulatory path. - Samuel Reich(CEO)

Contradiction Point 4

Number of Clinical Sites for the PRIZE Study

Contradiction on the scale and geographic spread of the PRIZE study's clinical sites.

What were the key points discussed in HC Wainwright's earnings call? - HC Wainwright

2026Q2: The PRIZE study has 7 sites total (4 in the U.S., others in Europe). - Alexander Kropotkova(Chief Medical Officer)

Have you commented on the number of sites expected in the prize study and whether the enrollment cadence timing is similar to safeguard, and what aspects of the TZIELD launch are you tracking to frame the SAB 142 opportunity? - Kumar Raja (Brooklyn Capital Markets)

2026Q1: Based on the number of sites, the company expects 20% or more of patients to be enrolled in the U.S., 60% or so in Europe (including the U.K.), with the remainder in Australia. - Samuel Reich(CEO)

Contradiction Point 5

Impact of T-ZIELD Approval on Investigator Interest

Contradiction on whether the recent FDA approval for a competitor has increased interest in SAB's trials.

What were Chardan's earnings results? - Chardan

2026Q2: The impact of T-Zield's approval on investigator interest in SAB's study has not been noted to date. - Samuel Reich(CEO)

Are you seeing increased investigator interest in your study following the FDA's expanded label approval for T-SHIELD? - Kumar Raja (Brooklyn Capital Markets)

2026Q1: Feedback is consistent across agencies. The company's priority is the U.S., but this is a global program, and they plan to seek approval in the U.S., Europe, and other regions to commercialize the drug globally. - Samuel Reich(CEO)