SAB BIO Q3 2026 Earnings Call - SAB BIOTHERAPEUTICS INC

Financial Performance:

• Ending cash, cash equivalents, and investment securities totaled $205 million as of September 30, 2026.
• Management projects current cash reserves will fund operations through 2028.
• Q3 2026 R&D expenses were $18.1 million, up from $9.0 million in Q3 2025, driven by clinical trial costs and headcount for the SAFEGUARD study; non-cash stock-based compensation (SBC) within R&D was $3.9 million.
• Q3 2026 G&A expenses were $7.8 million, up from $3.7 million in Q3 2025, primarily due to personnel costs and non-cash SBC of $3.6 million.
• Other income decreased to $3.6 million from $58.1 million in the prior year period, reflecting a change in fair value of warrant liabilities recognized in 2025.
• Net loss for Q3 2026 was $22.3 million, compared to a net income of $45.4 million in Q3 2025.
• Generated $13.4 million in gross proceeds from the exercise of warrants related to the July 2025 PIPE.

Guidance and Future Outlook:

• Reaffirmed guidance to complete enrollment in the SAFEGUARD (Phase 2b) study by the end of Q4 2026.
• Expect top-line data from the SAFEGUARD study to be released in the second half of 2027.
• The PRISE (Phase 3) study is expected to dose its first patient in Q3 2026, with results anticipated subsequent to SAFEGUARD data.
• Long-term goals include preparing for commercial readiness and establishing SAB142 as a potential long-term, redosable disease-modifying therapy.
• Strategic focus for 2027 is on achieving top-line data and building infrastructure to support long-term patient care.

Business Segments and Product Lines:

• Primary focus is the clinical development of SAB142, a fully human antithymocyte immunoglobulin designed to preserve beta cells in new-onset Type 1 Diabetes (T1D).
• SAFEGUARD Study: Adult and adolescent cohorts are fully enrolled and closed for screening; enrollment of children (ages 5-11) was approved by the Data Monitoring Committee (DMC) in September to accelerate progression.
• PRISE Study: An investigator-led Phase 3 trial targeting patients up to two years from a Stage 3 diagnosis; aims to support future label expansion.
• Regulatory Status: FDA granted Fast-Track designation in October for SAB142 (new-onset Stage 3 T1D), enabling expedited review and frequent FDA interactions.
• Differentiation: SAB142 utilizes a proprietary TC bovine platform to create fully human multispecific antibodies, offering low immunogenicity and potential for lifelong redosing compared to non-human approaches.

Market and Competitive Landscape:

• Management views the recent T-Field approval for Stage 3 T1D as a positive market catalyst that validates the unmet need and establishes a treatment paradigm for preserving the pancreas.
• SAB142 aims to differentiate via fewer dosing days, a better overall safety profile, and the capability for redosing due to its fully human nature.
• High physician and patient interest noted in the PRISE study, driven by pent-up demand from patients excluded from therapies with stricter enrollment windows (e.g., T-Field's 8-week limit vs. SAFEGUARD's 100-day limit).
• The PRISE study is designed to potentially expand the total addressable market by including patients up to two years post-diagnosis.

Risks and Challenges:

• Clinical development risks remain inherent, with actual results potentially differing from projections due to regulatory and trial execution factors.
• Future approval is not guaranteed by Fast-Track designation, though it facilitates the review process.
• Potential challenges include demonstrating efficacy in the 1–2 year post-diagnosis window for the PRISE study and managing the transition from Stage 3 to broader treatment eligibility.

Management Commentary and Tone:

• Tone is confident and optimistic, emphasizing "exemplary" clinical team performance and "strong momentum."
• Management expressed gratitude for the support of patients, investigators, and the broader diabetes community during Diabetes Awareness Month.
• Confident in the "serious aura" of the Fast-Track designation and the product's potential to "redefine" Stage 3 T1D treatment.

Analyst Questions and Answers:

• Differentiation & Data Expectations: UBS asked about C-peptide vs. A1C importance; CMO Alexandra Kopitova confirmed C-peptide is the primary endpoint for accelerated approval, with HbA1c and CGM data supporting glycemic control. Immunogenicity data is a key differentiator for long-term redosing.
• PRISE Study Cohorts: Barclays inquired about PRISE patient groups; explained cohorts are based on time from diagnosis (0-100 days, 100-365 days, 1-2 years) to prove beta cell preservation across the spectrum. Data timing is not yet guided but expected post-SAFEGUARD.
• Pediatric Safety: Jefferies asked about the DMC approval for pediatric enrollment; confirmed safety profile is consistent across adult, adolescent, and pediatric groups with no new safety signals.
• Redosing & Burn Rate: Guggenheim asked about redosing frequency; management confirmed redosing is on plan but did not disclose specific numbers. Burn rate includes PRISE expenses, so the study does not increase the guided cash burn.
• Baseline Characteristics: Lear Partners asked about patient baselines; confirmed they are consistent with historical trials (TN-19, ML-DTG). PRISE will begin with early age cohorts immediately given existing safety data.
• Physician Interest: Citi noted high inbound interest in PRISE due to the exclusion of many patients from current therapies; pediatric screening in SAFEGUARD is tracking as expected.
• Response Durability: Rodman Financial asked about the durability of "super responders" from prior Phase I data; confirmed Phase I was a 120-day study, so no data exists beyond that period without the redosing regimen used in SAFEGUARD.

Other Key Points:

• SAB142 is developed using a proprietary TC bovine platform to generate fully human antibodies without human donors.
• The PRISE study is co-funded by SAB Bio and supported by a grant from Breakthrough T1D, with Dr. Michael Haller (UF), Dr. Chantal Matthew (UZ Leuven), and Dr. Timothy Tree (King's College London) as principal investigators.
• The FDA Fast-Track designation includes eligibility for rollover and priority review of a future BLA, though it does not guarantee approval.