SAB Biotherapeutics, Inc. (SABS) 2026 Q2 法說會逐字稿

(Operator Instructions)

Good morning and welcome to SAB BIOS conference call to discuss second quarter 2026 financial results and business updates.

(Operator Instructions)

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 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 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 multi-billion dollar market opportunity through the development of a disease-modifying therapy.

Our lead product candidate, SAB142, is a fully human Anti-thymocyte globulin immunoglobulin 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 multispecific 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 self-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 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 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 doctor Michael Tyler, Professor and Chief of Pediatric Endocrinology at the University of Florida, in support of PRIDE-HAPG, a clinical study evaluating SAV-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.

SRIVE is an investigator-led Phase III study designed to assess the safety, efficacy, and tolerability of SAB142 in patients with Stage III 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-serial function may still be preserved.

PRIZE complements SAFEGUARD and extends the clinical evaluation of SAD-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 PC 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.

And 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 SAD142 through the registrational safeguarding 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 liabilities.

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 Prize through key milestones while preparing for commercial readiness for SAB 142.

And with that, I can turn it back over to Sam for closing remarks before we open the call for questions.

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 TSEAL 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 interventions and further establishing the regulatory path and commercial foundation for therapies like SAB-142.

We're encouraged by the face 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.

And with that, we're ready to take any questions.

Thank you. (Operator Instructions)

Thank you. We'll take our first question from Michael Yee with UBS. Please go ahead. Your line is open.

Good morning. This is Roy on for Mike. Thanks for taking my question. As it pertains to the data from SAFEGAURD and then Prize, could you maybe talk a little bit about the rationale behind the labeling strategy here and also the plan sequencing and timing of the filings? Thanks.

Well, Prize extends the patient population. The rationale is that.

Patients with type 1 diabetes still have C-peptide and still can make insulin even after 100 days. And that there's a tremendous unmet need and demand in the T1D community to be able to treat a patient after this window of diagnosis that's been created by kind of clinical trial protocols.

So one of the reasons why Michael Haller applied for this grant and breakthrough T1D was.

Granted it, because this is a major unmet medical need, and this is an underserved market, and we should be able to treat as many patients as possible, regardless of, when they were diagnosed, as long as they're still making their own insulin.

The Prize trial is, of course, staggered behind Safeguard, and so the data from Prize would come later in the form of an SBLA.

To hopefully get that label expansion and treat patients up to two years after diagnosis.

Thank you. We'll move on now to Ellie Merle with Barclays.

Hey, this is Tejas on for Ellie. Thanks for taking your question and congrats on all the progress.

Could you just walk us through maybe the timeline for that CRI study in this expanded population? And then just relative to the opportunity in those patients under 100 days, how much larger could this expanded cohort be? And what would good data look like in this larger population relative to the initial population?

We expect PRISE to start enrolling in the second-half of this year.

So there are 64,000 new patients diagnosed with type 1 diabetes every year.

And when they get diagnosed, they have a lot of decisions to make. It's a major life change. And they may right away feel overwhelmed by the new way they have to manage their life and so 100 days is a very short time to. That decision and if they're at 200 days or 400 days and they've got us and they still are making C-peptide, we want to be able to offer the medicine to them and they want to be able to get it and so it just... It's the same 64,000 patients, but it's a bigger opportunity for those patients to have time to make decisions and to get the drug. I mean, we see patients also on a regular basis that are past 100 days that want to be enrolled in the trial, or if they're past eight weeks and want to get T-Zeal, there's no options for that. We expect the data to be quite similar.

Because it's somewhat arbitrary, right? So it's the same disease, it's the point at which they start the drug, and we hope to preserve C-peptide. And so that's the goal, and it shouldn't look dramatically different.

Thank you. We'll move on now to Chacha Yang with Jefferies. Your line is now open.

Hi, thanks for taking my question. It's Chacha on for Roger.

Two questions from us. So, one is, can you tell us more about what drove the acceleration of recruitment for your Phase 2?

And then the second one, also on TRI for Phase 3.

Can you just speak to more about the package or the data that convinced the FDA to allow you to start the Phase 3 study? Thanks.

First question was on enrollment.

Acceleration.

We now have over 60 clinical sites actively recruiting.

We continue to build momentum and see great engagement and increased engagement from investigators and patients, and that has led to a growth in both screening and randomization.

But the major factor leading to the increased rate of enrollment is having more active clinical sites.

There's the second part. Can you repeat the second part of your question?

Yeah, second part is just about your phase three study and what data or package convinced the FDA and also convinced your team to allow you to start the phase three.

This is the prize study?

I mean, all the data we've shared to date, it was primarily the phase one data results.

And the excellent safety profile we have, redosability, and then you've seen that early evidence of efficacy from the patient cohort. That was what we submitted in the amended IND, and it led to opening that trial.

Thank you. We'll move on now to Thomas Smith with Leerink Partners. Your line is now open.

Hey guys, good morning. Congrats on all the progress and thanks for taking our questions. I was just wondering if you could elaborate a bit on your thoughts regarding the recent FDA approval for T-Zield in the Stage 3T1D population and specifically. Wondering how you think this potentially impacts the regulatory bar for success from the safeguard program and how you're thinking about The potential competitive landscape and just remind us how you view your competitive profile relative to the T field competitive profile. And then if I could ask just to follow-up on SAFEGUARD, wondering if you're able to comment at all on how the baseline characteristics of patients entering Part B are tracking versus your internal expectations, and how should we think about the baseline characteristics of these patients relative to the subjects in the Q1D cohort from the Phase 1 study? Thanks so much.

Well, TSO's approval is great news for both the type 1 diabetes community and for us.

This approval will help drive market awareness and education for disease-modifying therapies in T1D, and it further confirms C-peptide alone is sufficient for accelerated approval.

In terms of the regulatory bar or the regulatory path, I mean, we now have precedent that the FDA is allowing C-peptide for accelerated approval in T1D.

And in terms of the second part of your question, I'm going to ask our Chief Medical Officer, Alexander Kropotova, to answer that.

As far as the baseline characteristics in the ongoing SAFEGUARD trial, as our SAFEGUARD protocol requires at least 36 patients 5 to 11 years of age, two-thirds of the population below 18 years of age. And as far as the adult population, we are capping the adult population at 45 patients total. So, therefore, with the protocol requirements, our incoming baseline characteristics are very much in line with our expectations as we design the protocol.

The second part of the question, as far as the difference between the [SAGERD] population and the Phase I population.

[Favorite] population involves new onset stage 3 type 1 diabetes with D up to 100 days from the disease onset. In the phase 1 population, it was beyond the time from the onset was beyond 100 days.

That Phase 1 population is closer to the prize target patient population as far as the time from the disease onset. The rest of it is very identical as far as the preserved C-peptide at or above 0.2 nanomolars per liter.

And in terms of advantages of SA-B142.

I think the data shows we believe that SAP-142 offers fundamental efficacy, safety, and dosing advantages over Tzield, because of low to no immunogenicity, SAP-142 is well positioned for safe redosing over the lifetime of the disease so long as C-peptide is preserved.

It is a two-day dosing versus a 12-day dosing.

And just a reminder that in the PROTECT study, Tzield hit C-peptide, but missed secondary endpoints, whereas in the sort of our reference molecule, Rabbit ATG or thymoglobulin, HbA1c has been shown to be reduced in both the TN19 and the MELD study.

Thank you. We'll move on now to Samantha Semenkow with Citi. Your line is open.

Hi, good morning. This is Ben on for Samantha.

Thank you so much for taking our question.

Can you talk about the population you're enrolling in the PRI study and how it compares to SAFEGUARD?

Other than the time since diagnosis, how similar are these populations and should we expect them to have less beta cell function or is that not always the case?

Thank you.

All right, Alexandra.

Great question. And outside of the time from the disease onset, the rest of the inclusion/exclusion criteria are identical between the Safeguard and the PRICE study. As I mentioned earlier, the PRICE protocol has the inclusion criterion for the CPAP type at the baseline, identical to Safeguard or many other trials in the new onset where the CPAP type is required. To be at or above 0.2 nanomolars per liter. So, we don't expect that the price patient population will have lower level of the baseline C peptide, which is very much in line with the vast majority of the epidemiological data on natural history of the disease progression that shows that patients beyond 100 days have the preserved C peptide for years and years after the disease onset.

As an example shows that the CPAP site can be preserved for up to 15 years from the disease onset in both pediatric and adult patient population.

Thank you. We'll move on now to Kay Nakae with Chardan. Please go ahead, your line is open.

Yeah, hi, it's Kay from Chardan.

Sam, just kind of a follow-up on the FDA action on the expanded label for T-SEAL.

Just wondering, since that's occurred, are you seeing maybe more inbound interest from investigators in your study? I know that the enrollment was accelerated to a pure number of sites, but just wondering about how the FDA action has possibly increased interest in what you're doing?

I think that we probably haven't noted that to date because it's a similar community, but I think an important reminder is just that TZield is only approved in the U.S. For stage 3. The majority of our sites are in Europe.

TZield's approved label is limited to patients 8 to 17 within eight weeks of diagnosis, and Safeguard is evaluating patients ages 5 to 40 within 100 days of diagnosis.

There are even patients in the U.S. Who have, we've heard about, that have elected to enroll in Safeguard because of FAB142's competitive dosing profile, even after TVO has become available?

Thank you. We'll move on now to Seema Sharon with Rodman and Rinshaw. Your line is open.

Hi.

Thank you for taking my question and congrats on the progress.

Can you update us on the timing and status of the step-down to patients 5 and above? And I have a follow-up.

Sure.

So we anticipate the step-down to pediatric patients this quarter, and full enrollment of the safeguard remains on track to be completed in Q4.

Yeah, so considering that the Part B full enrollment will happen in fourth quarter and then the site activation and last patient in will drive your ability to lock and clean the database, how confident are you in delivering the top-line data in second-half, which I'm assuming is going to be fourth quarter?

Well, our guidance doesn't change as long as we are planning to complete enrollment in Q4 of this year. We should have top-line data in the second-half of '27.

Okay, that's helpful. One more question. How is the PRICE HADG study powered? That's my last question.

Thank you.

I'll let Alexandra answer that.

PRIZE-EKG study is the registrational trial and therefore adequately powered to detect the difference between the active and placebo for the primary endpoint, which is the C-peptide at 12 months following the two-hour MMTT. It's also powered for the key secondary point on the glycemic control in a similar manner as the SAVER trial.

I see, so it's like 80% powered for.

At least 40% difference on feedback type.

Thank you. We'll move on next to Emily Bodner with H.C. Wainwright. Your line is open.

Hi, thanks for taking the questions.

Have you commented on how many sites you're expecting to be included in the prize study? Just kind of curious on if timing for enrollment cadence could be similar to SAFEGUARD.

And then secondly, with the TZield approval now in stage three, are there any aspects of the T-Zield launch that you're tracking to kind of help frame the SAB 142 opportunity?

Thank you.

The first question, the first part, and I'll take it.

So, the price[ EQG study] has seven sites.

Four of them are in the U.S. And other sites are in Europe.

The study starts staggered versus safeguard, and the toll plan results for the price are expected in Q1 of 2029.

And for TZield. We'll continue to monitor TZield's launch and how it progresses, but it's too soon for us to draw conclusions.

The recent quarterly disclosure likely reflects the pediatric expansion in EU approval in Stage 2 rather than Stage 3, which was just approved mid-June.

More importantly, TZield's approval is good news for patients, the field, and for SAB. It helps drive awareness and education, and it further confirms C-peptide is sufficient for accelerated approval.

We'll move next to Kumar Raja with Brookline Capital Markets. Your line is open.

Thanks for taking my questions. I just had one follow-up on the number of sites.

Given that for the price study of Planning 7 sites, how do you think you'll be able to enroll so quickly that the number of patients are much larger?

And then I had a question on safeguard.

What are you seeing there in terms of, screening failure rate?

Thank you.

Excellent question on the enrollment and as we already mentioned, PRICE study is the only trial that allows enrollment of the patient population up to 730 days from the disease onset. There are no other trials, ongoing trials targeting this, allowing this patient population to be treated. So, there is already a great demand from the patient community who are beyond 100 days, highly interested in this clinical trial, and that enables a very efficient enrollment over a smaller number of sites.

So we're not disclosing screen failure rates or other detailed information like that. We're just reminding that enrollment remains on track to be completed in Q4.

Okay. And in terms of drug supply, where do you stand with regard to that?

Thank you.

We have sufficient supply to supply both trials.

Okay, great. Thanks so much.

Thank you.

This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.