SAB Biotherapeutics, Inc. Common Stock 2026 Q2 Earnings Call

Thank you, operator. Good morning, and thank you to everyone joining us for our second quarter 2026 earnings call. I'm joined today by Lucy To, our Chief Financial Officer, who will review the second quarter financial updates. I'm also joined by Eddie Sullivan, our Co-Founder and President, and Alexandra Kropotova, our Chief Medical Officer. We're 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 in our SAFEGUARD study, and advancing key clinical and operational priorities. For those who may be new to the SAB Bio story, we are a clinical-stage biopharmaceutical company focused on developing disease-modifying therapies for Type 1 diabetes and other autoimmune diseases. Our mission today is to redefine what it means to be diagnosed with Type 1 diabetes by developing a medicine to change the course of disease.

With millions of people living with Type 1 diabetes worldwide, we are pursuing a multibillion-dollar market opportunity through the development of a disease-modifying therapy. Our lead product candidate, SAB-142, is a fully human anti-thymocyte immunoglobulin designed to preserve insulin-producing beta cells with the goal of slowing disease progression in autoimmune Type 1 diabetes. We produce SAB-142 using our proprietary Tc Bovine platform, which allows us to generate fully human multi-specific antibodies without the need for human donors. Phase I data for SAB-142 showed a favorable safety profile, further validated its mechanism of action, and demonstrated early signals of beta cell preservation. We are now focused on enrolling our registrational Phase II-B clinical trial, called SAFEGUARD, in patients with newly diagnosed Stage 3 Type 1 diabetes. With that context, let's move into key updates from the second quarter, starting with enrollment updates for SAFEGUARD.

We are proud to report on the team's considerable progress with over 60 clinical sites actively recruiting. We are seeing increased engagement from investigators and patients, which is reflected in steady growth in both screening and randomization. As a reminder, Part A completed enrollment last quarter. Part B is actively enrolling, and the first step down to adolescent patients aged 12 and older was approved. We have seen an increase in enrollment driven by the activation of additional clinical sites. With this momentum, we remain on track to complete enrollment in Q4, with top-line data expected in the second half of 2027.

Building on this progress, we were excited to announce that Breakthrough T1D awarded a grant to Dr. Michael Haller, professor and chief of pediatric endocrinology at the University of Florida, in support of PRISE-hATG, a clinical study evaluating SAB-142 in patients with recent and extended onset Stage 3 Type 1 diabetes. We believe this support is particularly meaningful because it represents external belief in our approach from an organization dedicated to advancing therapies for people living with Type 1 diabetes. We are happy to be co-funding this study and continuing our collaboration with Dr. Haller and Breakthrough T1D. PRISE is an investigator-led Phase III study designed to assess the safety, efficacy, and tolerability of SAB-142 in patients with Stage 3 Type 1 diabetes who are 100 days to two years from diagnosis.

This is an area of significant unmet need, as it represents a critical window where residual beta cell function may still be preserved. PRISE complements SAFEGUARD and extends the clinical evaluation of SAB-142 in a broader patient population. Importantly, if successful, PRISE has the potential to support a future label expansion that could extend eligibility to patients up to two years from a Stage 3 Type 1 diabetes diagnosis. Our top priority in 2026 is clinical trial execution and on-time delivery of our key clinical milestones. At SAB, 2026 is the year of trial maxing, putting clinical trial execution at the center of everything we do. That focus on execution is what we believe will unlock the full value of our pipeline for patients and shareholders alike. Beyond clinical development, we also continued investing in our TC Bovine platform.

This quarter, we began construction of a second farm facility in South Dakota. This facility establishes a redundant herd in order to reduce operational risks and support long-term commercial supply for SAB-142. With that, I'll turn it over to Lucy to review our second quarter financial updates.

Thanks, Sam. We ended the quarter with $208 million in cash equivalents, and investment securities as of June 30, 2026. We continue to have a strong cash position with operational runway through 2028.

R&D expenses were $16.2 million for the second quarter of 2026, compared to $7 million for the same period in 2025. The increase is primarily driven by ongoing clinical trial costs and related headcount to support the advancement of SAB-142 through the registrational SAFEGUARD study. G&A expenses were $7.2 million for the second quarter of 2026, compared to $2.7 million for the same period in 2025. The increase is driven by higher headcount costs, including related stock-based compensation. Other income was $0.9 million for the second quarter of 2026, compared to an expense of $0.4 million for the same period in 2025. This change is driven by an increase in interest and dividend income as a result of higher average balances in our investment portfolios, partially offset by changes in fair value of warrant liability.

As a result, net loss was $22.5 million for the second quarter of 2026, compared to $10.1 million for the same period in 2025. Overall, we are well capitalized to support SAFEGUARD and PRISE-hATG through key milestones while preparing for commercial readiness for SAB-142. With that, I can turn it back over to Sam for closing remarks before we open the call for questions.

Thanks, Lucy. As we look ahead to the rest of the year, our focus remains on execution, completing enrollment of SAFEGUARD in Q4 this year and continuing to build the capabilities needed to support SAB-142 over the long term. The recent FDA approval of Tzield for children and adolescents recently diagnosed with Stage 3 Type 1 diabetes is an important milestone for the T1D community and for our field, reinforcing the value of early disease-modifying intervention and further establishing the regulatory path and commercial foundation for therapies like SAB-142. We're encouraged by the pace of enrollment in SAFEGUARD and the enthusiasm we're seeing from investigators and patients, which underscores both the interest in SAB-142 and the broader momentum behind disease-modifying approaches. Our goal is simple, to deliver a therapy that can change the course of Type 1 diabetes and make that benefit available to as many patients as possible.

We are excited about what lies ahead and look forward to sharing our progress as we continue advancing our programs and executing on our strategy. With that, we're ready to take any questions.