8/6/2026

speaker
Operator
Operator

Good morning and welcome to SAB Bios, conference call to discuss second quarter 2026 financial results and business updates. Listeners are invited to review the full text of the forward-looking statements from this morning's quarterly earnings press release. Company management may provide projections during this call, and actual results could differ materially due to several factors, including those outlined in the company's latest filings with the SEC. All participants are in a listen-only mode. Following management's remarks, we will open the call for questions. This call is being webcast live and can be accessed on the Investors section of SABbio's website at ir.sab.bio where a replay will be available. I'll now turn the call over to Samuel Reich, Chief Executive Officer of of SAP Pio.

speaker
Samuel Reich
Chief Executive Officer

Thank you, operator. Good morning, and thank you to everyone joining us for our second quarter 2025 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've remained 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 SAV 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 multi-billion dollar market opportunity through the development of a disease-modifying therapy. Our lead product candidate, SAB142, is a fully human anti-thymocyte aminoglobulin designed to preserve insulin-producing beta cells with the goal of slowing disease progression in autoimmune type 1 diabetes. We produce SAB142 using our proprietary TC Bovine platform which allows us to generate fully human, multi-specific antibodies without the need for human donors. Phase 1 data for SAB142 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 2B 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 recruited. 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 age 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, and supportive prize, HAPG, a clinical study evaluating SAB142 in patients with recent and extended onset stage three type one 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 one diabetes. We are happy to be co-funding this study and continuing our collaboration with Dr. Haller and Breakthrough T1D. PROMISE is an investigator-led phase three study designed to assess the safety, efficacy and tolerability of SAB142 in patients with stage three type one 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. Prize compliments safeguard and extends the clinical evaluation of SAB 142 in a broader patient population. Importantly, if successful, Prize 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 SAV, 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 risk and support long-term commercial supply for SAB 142.

speaker
Samuel Reich
Chief Executive Officer

And with that, I'll turn it over to Lucy to review our second quarter financial updates.

Disclaimer

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