SAB Biotherapeutics, Inc. Q1 FY2026 earnings call

• Clinical Development Milestones for SAB142

  • Part A (dose-ranging) of the registrational Phase IIb Safeguard trial completed enrollment during Q1 2026; Part B (randomized double-blind placebo-controlled) enrollment initiated in Q1 and is ongoing. The full trial is on track to complete enrollment by the end of 2026, with top-line data expected in H2 2027.
  • The trial's Data Monitoring Committee approved enrollment expansion to patients aged 12 and older, following a review of 4 weeks of safety data from the 12 Part A patients.
  • Positive exploratory Phase I data presented at the Immunology of Diabetes Society Congress: 3 of 4 treated participants were super responders with C-peptide levels at or above baseline at day 120; mean time in range for glycemic control improved from 73% at baseline to 85% at day 120 without increased exogenous insulin use, with C-peptide preservation correlated to T-cell exhaustion.
  • The trial is conducted across multiple clinical sites in the U.S., Australia, New Zealand, the U.K., and the EU, enrolling 159 total recently diagnosed stage 3 type 1 diabetes patients aged 5 to 40.

• Regulatory Update

  • The company received written confirmation from the FDA that C-peptide is an acceptable surrogate endpoint for accelerated approval of SAB142, which materially de-risks the regulatory path to market.
  • Feedback from other global regulators including the EMA is aligned with the FDA's position on the clinical development plan.

• Business and Financial Updates

  • A public offering completed in March 2026, with full exercise of the underwriters' over-allotment option, generated aggregate gross proceeds of approximately $95 million.
  • The company entered a multi-year agreement with Emergent BioSolutions in late April 2026 to support process development, clinical manufacturing, and commercial manufacturing of SAB142, positioning the company to scale production for a potential commercial launch.
  • The company's $217.6 million cash position provides an operational runway through 2028, fully supporting completion of the Safeguard trial and pre-commercial activities.

SAB Bio is a clinical-stage biopharmaceutical company with no commercial product sales as of Q1 2026, so it has no active revenue-generating product segments. The company's only clinical-stage product candidate is SAB142 for type 1 diabetes, and all expenses are directed to advancing this program. Q1 2026 financials: Total R&D expenses were $13.4 million (up from $7.7 million in Q1 2025); G&A expenses were $6.6 million (up from $3.1 million in Q1 2025); other income was $1.1 million (down from $5.6 million in Q1 2025); net loss was $18.9 million (compared to a $5.2 million net loss in Q1 2025). As of March 31 2026, the company held $217.6 million in cash, cash equivalents, and available-for-sale securities.

• SAB142's Phase IIb Safeguard trial enrollment is projected to be completed by the end of 2026, with top-line data expected in the second half of 2027; this timeline is unchanged from prior projections and remains on track.
• The company does not currently plan to release interim Part A dose-ranging data before completion of the full Safeguard trial.
• Enrollment expansion to patients aged 5 to 11 is expected to be approved in the coming months, following additional safety reviews of data from patients aged 12 and older.
• The company's current cash position is sufficient to support all planned operational activities through 2028, with no upward or downward revision to this projection.

As of Q1 2026, the company did not disclose any new material operational risks, trial failures, or unexpected adverse safety events during the earning call. All standard risk disclosures are referenced in the company's existing SEC filings, with the note that forward-looking projections may differ materially from actual results. Key inherent risks for the company include uncertainty of clinical trial success, regulatory approval risk, and reliance on a single lead product candidate.

Q: How is SAB142 mechanistically differentiated from anti-CD3 monoclonal antibodies, and how does this impact safety and clinical activity? / A: Anti-CD3 antibodies have a single target, and their dosing for T-cell exhaustion also negatively impacts Tregs that are critical for self-tolerance, creating a counterproductive effect. SAB142 is a polyclonal fully human anti-thymocyte immunoglobulin that binds multiple T-cell targets, allowing T-cell exhaustion induction at low doses that preserve and may even activate Tregs. SAB142 also has no observed immunogenicity or serum sickness, enabling safe chronic redosing that competitor products cannot support, which management expects will lead to better long-term clinical outcomes.

Q: Do you plan to release Part A Safeguard data early, and does Phase 1 data support expansion to established type 1 diabetes? / A: Management has no current plans to release interim Part A data ahead of full trial completion. The four patients treated in Phase 1 all had established type 1 diabetes (two or more years post-diagnosis) and still showed positive therapeutic effects, which supports the company's plan to pursue indication expansion to established patients. Successful expansion would double the company's addressable market.

Q: What C-peptide endpoint goal has been set for the Safeguard trial, given the super responder Phase 1 results? / A: The primary goal for the larger, longer Phase IIb trial is to demonstrate C-peptide preservation relative to baseline at one year, which would meet the trial's primary endpoint and the FDA's requirements for accelerated approval. While seeing increased C-peptide (as seen in Phase 1 super responders) would be an exciting additional outcome, demonstration of sustained C-peptide preservation is the targeted primary success endpoint.

Q: What is the geographic patient split for the 159-patient Safeguard trial, and do you plan to pursue accelerated approval globally? / A: Management expects ~20% of patients to be enrolled in the U.S., ~60% in the EU and U.K., and the remainder in Australia and New Zealand. The company's near-term priority is U.S. approval, but it plans to pursue global approval across major markets. While it is early to confirm accelerated approval pathways in non-U.S. regions, regulatory feedback to date has been consistent with the FDA's alignment on the trial design.