SAB Biotherapeutics, Inc.

Good morning and welcome to the SAB BIOS conference call to discuss first quarter 2026 financial results and business updates. Listeners are invited to review the full text of the forward-looking statements from the morning's quarterly earnings press release. Company management may provide projections during the call and actual results could differ materially due to several factors such including those outlined in the company's latest filings with the SEC. Currently, 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 investor section of SABBIO's website at ir.sab.bio.com. where a replay will be available. I'll now turn the call over to Samuel Reich, Chief Executive Officer of SAB Bio.

Thank you, Operator. Good morning, and thank you to everyone joining us for our first earnings call. We're excited to have you with us to share the progress our team has made in the first quarter, progress that sets a strong foundation for the rest of 2026. For those of you who may be new to our story, let me take a moment to introduce SAB Bio, our mission, and our focus. SAB Bio is a clinical stage biopharmaceutical company focused on developing fully human anti-thymocyte immunoglobulin for type 1 diabetes and other autoimmune diseases. Our mission is to dramatically redefine what it means to be diagnosed with type 1 diabetes by developing a medicine to change the course of disease, not just treat the symptoms. Our lead product candidate, SAB142, is a potentially disease-modifying, redosable immunotherapy in clinical development for the treatment of autoimmune type 1 diabetes. We produce SAB142 using our proprietary TC Bovine platform, which allows us to generate fully human immunoglobulin without the need for human donors. SAB142 works by directly targeting multiple immune cells involved in destroying insulin-producing beta cells. Its mechanism of action has been clinically validated in numerous clinical trials with rabbit anti-thymocyte globulin. We have generated highly positive Phase I data demonstrating encouraging efficacy signals and a validated mechanism of action with sustained immunomodulation. SAB142's Phase I data showed early C-peptide signals demonstrating beta cell preservation and a favorable safety profile resulting in no serum sickness and low or no immunogenicity, allowing for chronic redosing. Following these results, we advanced SAB142 into a registrational Phase IIb trial called Safeguard, which was initiated last year, with the first patient dosed in December. We believe SAB142 has the potential to fundamentally change how type 1 diabetes is treated and address a major unmet medical need. In the U.S., there are over 2 million people diagnosed with stage 3 or symptomatic type 1 diabetes and approximately 64,000 patients newly diagnosed each year. Now to the first quarter update. I am thrilled with the progress our team has made this quarter. We executed on every front and we're standing on business. The momentum is real and it's building. Here's how. Starting with the safeguard trial, Enrollment is progressing on schedule and remains on track to be completed by the end of this year, with top-line data expected in the second half of 2027. We are continuing to activate multiple clinical trial sites across the U.S., Australia, New Zealand, the U.K., and the European Union. To remind everyone on the call, the safeguard trial will enroll a total of 159 stage 3 type 1 diabetes patients between the ages of 5 and 40, all within 100 days of diagnosis. It is structured in two parts. Part A, our dose-ranging study in 12 adult patients, completed enrollment during the first quarter, representing a notable milestone. Part B, our randomized double-blind, placebo-controlled study, enrolling 147 pediatric adolescent and adult patients, was initiated in the first quarter and is actively enrolling now. Additionally, our study data monitoring committee, recently approved the first step down to enroll patients ages 12 and older. The pace of enrollment and the enthusiasm from investigators reinforces the urgent and unmet need in the type 1 diabetes community for therapies that go beyond insulin management to actually address the underlying autoimmune disease. Another significant highlight this quarter was that we received written correspondence from the FDA confirming that C-peptide may serve as a surrogate endpoint for accelerated approval. This represents a meaningful de-risking of our regulatory path. This written confirmation gives us greater confidence and clarity as we execute safeguard and plan our path to market. We also recently shared new findings from SAB 142's Phase 1 study at the Immunology of Diabetes Society Congress. The data presented highlighted SAB 142's mechanism of action, along with demonstrating that the mechanism translates into clinical benefit for people with type 1 diabetes. The phase 1 data for SAB 142 showed preservation of C-peptide levels correlated with evidence of T-cell exhaustion. Of the four SAB 142 treated participants, three demonstrated a super responder profile with C-peptide levels at or above baseline at day 120. Those treated participants showed improved glycemic control, with mean time and range increasing from 73% at baseline to 85% at day 120, without an associated increase in exogenous insulin use. While early and exploratory, these results are encouraging and further build confidence as we advance SAB 142 in the safeguard trial. For more details, you can explore the full data presentation on our website. Finally, on the business side, on April 29th, we executed a multi-year agreement with Emergent BioSolutions to support the process development as well as clinical and commercial manufacturing of SAB 142 in anticipation of regulatory approval. This agreement positions us to scale manufacturing in support of a potential commercial launch. We are confident having such a capable and experienced partner like Emergent in place as we advance towards that milestone. And with that, I'll turn the call over to Lucy To, our Chief Financial Officer, to review our first quarter earnings and financial updates.

Thanks, Sam. We ended the first quarter with $217.6 million in cash, cash equivalents, and available for sale securities as of March 31, 2026. The strong cash position provides us with an operational runway through 2028. fully supporting the execution of safeguard and our pre-commercial activities. Contributing to this position was our public offering that was completed in March. Following the initial closing, the underwriters exercised their over-allotment option, resulting in aggregate gross proceeds of approximately $95 million. We are well capitalized and well positioned to execute our plans. Our R&D expenses were $13.4 million for the first quarter of 2026, compared to $7.7 million for the same period in 2025. The increase is driven by the ongoing investments made to advance the SAB 142 program in the safeguard trial, including site activation and patient enrollment. This is exactly where we expect to be investing. G&A expenses were $6.6 million for the first quarter of 2026 compared to $3.1 million for the same period in 2025. The increase was primarily driven by higher non-cash stock-based compensation expenses and personnel-related costs associated with our expanded team. As we scale, these investments in our operational foundation are necessary and expected. Other income was $1.1 million for the first quarter of 2026 compared to $5.6 million for the same period in 2025. This decrease was driven by the change in fair value of warrant liabilities. As a result of these factors, net loss was $18.9 million for the first quarter of 2026 compared to $5.2 million for the same period in 2025. The financial results reflect a company that has the resources, discipline, and runway to see safeguard through to completion and to begin building toward commercial readiness. And with that, I can turn it back over to Sam for closing remarks before we open the call up for questions. Thanks, Lucy.