Q2 2026 SAB Biotherapeutics Inc Earnings Call

August 6, 2026

Speaker #2: Please stand by . Your meeting is about to begin Good morning and welcome to SAB Bio's Conference call to discuss second quarter 2020 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 .

Operator: 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. 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 investors section of SAB Bio'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 SAB Bio.

Speaker #2: 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 with the SEC .

Speaker #2: 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 SAB Bio's website at IR dot a dot b I o , where a replay will be available .

Speaker #2: I'll now turn the call over to Samuel Reich , Chief Executive Officer of SAB bio .

Speaker #3: Thank you . Operator . Good morning , and thank you to everyone joining us for our second quarter 2020 earnings call . I'm joined today by Lucy , our chief Financial Officer , who will review the second quarter financial updates .

Samuel J. Reich: Thank you, operator. Good morning, and thank you to everyone joining us for our Q2 2026 earnings call. I'm joined today by Lucy To, our Chief Financial Officer, who will review the Q2 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 Q2. 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.

Speaker #3: I'm also joined by Eddie Sullivan , our co-founder and president . And Alexandra , our chief medical officer . We're pleased to have you with us today to share the progress we've made in the second quarter .

Speaker #3: 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 one diabetes and other autoimmune diseases Our mission today is to redefine what it means to be diagnosed with type one diabetes by developing a medicine to change the course of disease .

Speaker #3: With millions of people living with type one 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 one diabetes .

Samuel J. Reich: 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, SAB-142, is a fully human antithymocyte 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 IIB 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 Q2, starting with enrollment updates for SAFEGUARD.

Speaker #3: We produce SAB 142 using our proprietary bovine platform , which allows us to generate fully human multispecific antibodies without the need for human donors Phase one 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 two clinical trial , called Safeguard in patients with newly diagnosed stage three type one diabetes With that context , let's move into key updates from the second quarter .

Speaker #3: Starting with enrollment updates for safeguard , we are proud to report on the team's considerable progress with over 60 clinical sites actively recruiting .

Samuel J. Reich: 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 H2 2027.

Speaker #3: We are seeing increased engagement from investigators and patients , which is reflected in steady growth in both screening and randomization . As a reminder card , 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 .

Speaker #3: With this momentum, we remain on track to complete enrollment in Q4, with top-line data expected in the second half of 2027.

Speaker #3: Building on this progress , we were excited to announce that breakthrough T one D awarded a grant to Doctor Michael Haller , professor and Chief of pediatric Endocrinology at the University of Florida , in support of pride HATG .

Samuel J. Reich: 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 PRIZE-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. PRIZE 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.

Speaker #3: A clinical study evaluating SAB one , 42 in patients with recent and extended onset stage three type one diabetes . We believe that this particularly meaningful because it represents external belief in our approach from an organization dedicated to advancing therapies for people living with one diabetes .

Speaker #3: We are happy to be co-funding this study and continuing our collaboration with Doctor Haller and Breakthrough T1D . Mine is an investigator led phase three study designed to assess the safety , efficacy and tolerability of SAB 142 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 by complement , safeguard and extends the clinical evaluation of SAB .

Samuel J. Reich: This is an area of significant unmet need, as it represents a critical window where residual beta cell function may still be preserved. PRIZE complements 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 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.

Speaker #3: 142 in a broader patient population Importantly , if successful , price has the potential to support a future label expansion that could extend eligibility to patients up to two years from a stage three type one diabetes diagnosis Our top priority in 2026 is clinical trial execution .

Speaker #3: 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 PK bovine platform This quarter , we began construction of a second farm facility in South Dakota .

Samuel J. Reich: 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 Q2 financial updates.

Speaker #3: 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

Speaker #4: Thanks , Sam . We ended the quarter with $208 million in cash . Cash equivalents , and investment securities . As of June 30th , 2026 .

Lucy To: Thanks, Sam. We ended the quarter with $208 million in cash equivalents, and investment securities as of 30 June 2026. We continue to have a strong cash position, with operational runway through 2028. R&D expenses were $16.2 million for Q2 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 Q2 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 Q2 2026, compared to an expense of $0.4 million for the same period in 2025.

Speaker #4: 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 $7.0 million for the same period in 2025.

Speaker #4: 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.

Speaker #4: 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 was 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 .

Speaker #4: 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 the 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.

Lucy To: 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. Net loss was $22.5 million for Q2 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.

Speaker #4: Overall , we are well capitalized to support , safeguard and prize through key milestones while preparing for commercial readiness for SAB . 142 .

Speaker #4: And with that , I can turn it back over to Sam for closing remarks before we open the call for questions

Speaker #3: 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 Tisseel for children and adolescents recently diagnosed with stage three type one 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 to commercial foundation for therapies like SAB .

Samuel J. Reich: 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.

Speaker #3: 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 .

Speaker #3: Our goal is simple to deliver a therapy that can change the course of type one diabetes and make that benefit available to as 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

Samuel J. Reich: 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.

Speaker #2: Thank you . If you'd like to ask a question , press star one . Now on your telephone keypad to leave the queue at any time , please press star two .

Operator: Thank you. If you'd like to ask a question, press *1 now on your telephone keypad. To leave the queue at any time, please press *2. Once again, that is *1 to ask a question, and we'll pause for just a moment to allow everyone a chance to join the queue. Thank you. We'll take our first question from Michael Yee with UBS. Please go ahead. Your line is open.

Speaker #2: Once again , that is star one . To ask a question . And we'll pause for just a moment to allow everyone a chance to join the queue Thank you .

Speaker #2: We'll take our first question from Michael Yee with UBS . Please go ahead . Your line is open

Speaker #5: Good morning . This is Roy on for Mike . Thanks for taking my question . As it pertains to the data from safeguard .

[Analyst] (UBS): Good morning. This is Roy on for Mike. Thanks for taking my question. As it pertains to the data from SAFEGUARD and then PRISE-hATG, could you maybe talk a little bit about the rationale behind the labeling strategy here, and also the planned sequencing and timing of the filings? Thanks.

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

Speaker #5: 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 ?

Speaker #5: Thanks

Speaker #3: , well , price extends the patient population . The rationale is that patients with type one diabetes still have c-peptide and still can make insulin , even after 100 days .

Samuel J. Reich: Well, PRISE-hATG 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. 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 clinical trial protocols. One of the reasons why Michael Haller applied for this grant and Breakthrough T1D was granted it, was 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.

Speaker #3: 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 .

Speaker #3: So one of the reasons why Michael Haller applied for this grant and break through T1D was granted it was because this is a major unmet medical need .

Speaker #3: And this is an underserved market . And we should be able to treat as many patients as possible . Regardless of , you know , when they were diagnosed , as long as they're still making their own insulin , the prize trial is , of course , staggered behind safeguard .

Samuel J. Reich: The PRISE-hATG trial is, of course, staggered behind SAFEGUARD. The data from PRISE-hATG would come later in the form of an sBLA, to hopefully get that label expansion and treat patients up to two years after diagnosis.

Speaker #3: And so the data from prize would come later in the form of an sbla to to hopefully get that label expansion and treat patients up to two years after diagnosis

Speaker #5: Great . Thanks so much

[Analyst] (UBS): Great. Thanks so much.

Roy Au: Great. Thanks so much.

Speaker #3: You're welcome

Samuel J. Reich: You're welcome.

Speaker #2: Thank you We'll move on now to Ellie . Merle with Barclays . Your line is now open . Please go ahead

Operator: Thank you. We will move on now to Ellie Merle with Barclays. Your line is now open. Please go ahead.

Speaker #6: Hey , this is Chris on for Ellie . Thanks for taking our questions and congrats on all the progress , could you just walk us through maybe the timelines for that prize 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 ?

[Analyst] (Barclays): Hey, this is Tejas on for Ellie. Thanks for taking our question, and congrats on all the progress. Could you just walk us through maybe the timeline to that PRISE-hATG study in this expanded population? 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?

Teja S.: Hey, this is Teja S. on for Ellie. Thanks for taking our question, and congrats on all the progress. Could you just walk us through maybe the timeline to that PRISE-hATG study in this expanded population? 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?

Speaker #6: And what would good data look like in this larger population relative to the initial population

Speaker #3: We expect prize to start enrolling in the second half of this year . And 60 . So there are 64,000 new patients diagnosed with type one diabetes every year .

Samuel J. Reich: We expect PRISE-hATG to start enrolling in H2 of this year. There are 64,000 new patients diagnosed with type 1 diabetes every year. 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. 100 days is a very short time to make that decision. If they're at 200 days or 400 days, 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. 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.

Speaker #3: 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 the new way they have to manage their life .

Speaker #3: And so 100 days is a very short time to make that decision . And if they're at 200 days or 400 days and they've got 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 .

Speaker #3: 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 .

Speaker #3: And to , 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 diesel .

Samuel J. Reich: 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 Tzield, there's no options for them. We expect the data to be quite similar, because it's somewhat arbitrary, right? It's the same disease, it's the point at which they start the drug, and we hope to preserve C-peptide. That's the goal, and it shouldn't look dramatically different. I think I forgot the H2 of your question, Tejas. What was that?

Speaker #3: There's no options for them . We expect the data to be quite similar . , because it's somewhat arbitrary . Right ? So it's the same disease .

Speaker #3: It's the point at which they start the drug . And we hope to preserve c-peptide . And so , , that's the goal .

Speaker #3: And it shouldn't look dramatically different I think I forgot the second half of your question . I guess . What was that ?

Speaker #6: Oh , I said thanks for all the color .

[Analyst] (Barclays): I said thanks for all the color.

Teja S.: I said thanks for all the color.

Speaker #3: You're welcome

Samuel J. Reich: You're welcome.

Speaker #2: Thank you . We'll move on now to cha cha Yang with Jefferies . Your line is now open

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

Speaker #7: Hi . Thanks for taking my question . Cha cha 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 two ?

Cha Cha Yang: Hi, thanks for taking my question. This is Cha Cha on for Roger. Two questions from us. One is, can you tell us more about what drove the acceleration of recruitment for your phase II? The second one also on PRISE-hATG for phase III, can you just speak to more about the package or the data that convinced the FDA to allow you to start the phase III study? Thanks.

Speaker #7: And then the second one also on prize for phase three . , can you just speak to more about the package or the data that convinced the FDA to allow you to start the phase three study ?

Speaker #7: Thanks

Speaker #3: First question was on enrollment

Samuel J. Reich: First question was on enrollment?

Speaker #7: Acceleration

Cha Cha Yang: Acceleration of recruitment.

Samuel J. Reich: 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, that has led to a growth in both screening and randomizations. The major factor leading to the increased rate of enrollment is having more active clinical sites. There was a second part. Can you repeat the second part of your question?

Speaker #3: 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 .

Speaker #3: And that has led to a growth in both screening and randomizations But the major factor leading to the increased rate of enrollment is having more active clinical sites There's the second part .

Speaker #3: Can you repeat the second part of your question

Speaker #7: 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 .

Cha Cha Yang: Yeah. Second part is just about your phase III study and what data or package convinced the FDA and also what convinced your team to allow you to start the phase III.

Speaker #3: This is the prize study I mean , the , you know , all the data we've shared to date , it was primarily the phase one data results , and the excellent safety profile we have the reversibility .

Samuel J. Reich: This is the PRISE-hATG study?

Cha Cha Yang: That's right.

Samuel J. Reich: All the data we've shared to date, it was primarily the phase I data results, and the excellent safety profile we have, redosability, and you've seen that early evidence of efficacy from the patient cohort. That was what we submitted in the amended INDs, and it led to opening that trial.

Speaker #3: And then you've seen that early evidence of efficacy from the patient cohort—that was what we submitted in an amended IND.

Speaker #3: And it led to opening that trial

Speaker #2: Thank you . We'll move on now to Thomas Smith with Leerink Partners . Your line is now open

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

Speaker #5: Hey , guys . Good morning

Thomas Smith: 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 Tzield in the Stage 3 T1D population and specifically, wondering how you think this potentially impacts the regulatory bar for success from the SAFEGUARD program, how you're thinking about the potential competitive landscape, and just remind us how you view your competitive profile relative to the Tzield

Speaker #8: 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 Tzield in the stage 3 T1D population. Specifically, I'm 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.

Speaker #8: And just remind us how you view your competitive profile relative to the PCL competitive profile And then if I could ask just a 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 ?

Thomas Smith: competitive profile. Then if I could ask just a 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. How should we think about the baseline characteristics of these patients relative to the subjects in the T1D cohort from the phase I study? Thanks so much.

Speaker #8: , and how should we think about the baseline characteristics of these patients relative to the subjects in the T1 d cohort ? From the phase one study ?

Speaker #8: Thanks so much

Speaker #3: All right . Well approval is great news for both the type one diabetes community and for us This approval will help drive market awareness and education for disease modifying therapies in T1D , and it further confirmed C-peptide alone is sufficient for accelerated approval .

Samuel J. Reich: Well, TZIELD'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. It further confirms C-peptide alone is sufficient for accelerated approval. In terms of the regulatory bar or the regulatory path, we now have precedent that the FDA is allowing C-peptide for accelerated approval in T1D. In terms of the second part of your question, I am going to ask our Chief Medical Officer, Alexandra Kropotova, to answer that.

Speaker #3: So 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 .

Speaker #3: And in terms of the second part of your question , I'm going to ask our Chief Medical Officer , Alexandra , to answer that

Speaker #9: As far as the baseline characteristics in the ongoing safeguard trial , as you know , protocol requires our safeguard protocol requires at least 36 patients , 5 to 11 years of age , two thirds of the population below 18 years of age .

Alexandra Kropotova: As far as the baseline characteristics in the ongoing SAFEGUARD trial, as you know, our SAFEGUARD protocol requires at least 36 patients, five to 11 years of age, two-thirds of the population below 18 years of age. As far as the adult population, we are capping the adult population at 45 patients total. Therefore, with the protocol requirements, our incoming baseline characteristics are very much in line with our expectations as we designed the protocol. Your second part of the question, as far as the difference between the SAFEGUARD population and the phase I population, SAFEGUARD population involves new onset Stage 3 Type 1 diabetes with the up to 100 days from the disease onset. In the phase I population, the time from the onset was beyond 100 days.

Speaker #9: And as far as the adult population , we have in 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 , your second part of the question .

Speaker #9: As far as the difference between the safeguard population and the phase one population safeguard population enrolls new onset stage three type one diabetes with the up to 100 days from the disease onset in the phase one population .

Speaker #9: It was beyond the time from the onset was beyond 100 days . , that phase one population is , , closer to the prize target patient population .

Alexandra Kropotova: That phase I 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 nanomoles per liter.

Speaker #9: 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 nanomoles per liter

Speaker #3: In terms of advantages of SAB 142 , I think the data shows we believe that SAB 142 offers fundamental efficacy , safety and dosing advantages over T field because of no low to no immunogenicity .

Samuel J. Reich: In terms of advantages of SAB-142, I think the data shows we believe that SAB-142 offers fundamental efficacy, safety, and dosing advantages over TZIELD. Because of low to no immunogenicity, SAB-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. Just a reminder that in the PROTECT study, TZIELD hits C-peptide but missed secondary endpoints, whereas in our reference molecule, rabbit ATG, or Thymoglobulin, HbA1c has been shown to be reduced in both the TN-19 and the MELD-ATG study.

Speaker #3: SAP 142 is well positioned for safe dosing over the lifetime of the disease , so long as C-peptide is preserved , it is a two day dosing versus a 12 day dosing .

Speaker #3: And just a reminder that in the Protect study , yield c-peptide but missed secondary endpoints , whereas in the the sort of our reference molecule HAT rabbit ATG , or thymoglobulin Hba1 C has been shown to be reduced in both the 19 and the MELD study

Speaker #8: Super helpful . Thanks so much .

Thomas Smith: Super helpful. Thanks so much.

Speaker #3: You're welcome .

Samuel J. Reich: You're welcome.

Speaker #2: Thank you . We'll move on now to Samantha Semenko with Citi . Your line is open

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

Speaker #10: 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 .

[Analyst] (Citi): 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 PRISE-hATG 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.

Speaker #10: , other than the time since diagnosis , , how similar are these populations and should we expect them to have less beta cell function ?

Speaker #10: Or is that not always the case . Thank you .

Speaker #3: All right . Alexandra .

Samuel J. Reich: All right. Alexandra?

Speaker #9: 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.

Alexandra Kropotova: Great question. Outside of the time from the disease onset, the rest of the inclusion/exclusion criteria are identical between the SAFEGUARD and the PRISE-hATG study. As I mentioned earlier, the PRISE-hATG protocol has the inclusion criterion for the C-peptide at the baseline identical to SAFEGUARD or many other trials in the new onset where the C-peptide is required to be at or above 0.2 nanomoles per liter. We don't expect that the PRISE-hATG 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.

Speaker #9: As I mentioned earlier , the . Price protocol has the inclusion criterion for the CGrp at the baseline , identical to safeguard or many other trials in the in the new Cpap date is required to be at or above 0.2 Nanomoles per liter .

Speaker #9: So we don't expect that the price patient population will have lower levels 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 .

Speaker #9: That shows that patients beyond 100 days have the preserved C peptide for years and years after the disease onset GC CT cohort as an example , shows that the C peptide can be preserved for up to 15 years from the disease onset , and both pediatric and adult patient population

Alexandra Kropotova: GC-CDiC cohort, as an example, shows that the C-peptide can be preserved for up to 15 years from the disease onset in both pediatric and adult patient population.

Speaker #2: Thank you . We'll move on now to Chi McKay with Chardon . Please go ahead . Your line is open

Operator: Thank you. We'll move on now to Kai Mackay with Chardan. Please go ahead, your line is open.

Speaker #11: Yeah . Hi , it's K from Jordan . , Sam , just kind of a follow up on the , , the FDA action on the expanded label for t shield .

Kai Mackay: Yeah. Hi, it's Kai from Chardan. Sam, just kind of a follow-up on the FDA action on the expanded label for Tzield. Just wondering, since that's occurred, are you seeing maybe more inbound interest from investigators in your study? I know the enrollment was accelerated due to the pure number of sites, just wondering about how the FDA action has possibly increased interest in what you're doing.

Speaker #11: , just wondering , since that occurred . Are you seeing maybe more inbound interest from investigators in your study ? I know that the enrollment was accelerated due to pure number of sites , but just wondering about how the FDA action has possibly increased interest in what you're doing

Samuel J. Reich: 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 US for Stage 3. The majority of our sites are in Europe. Tzield's approved label is limited to patients 8 to 17 within 8 weeks of diagnosis, and Safeguard is evaluating patients ages 5 to 40 within 100 days of diagnosis. There are even patients in the US who we've heard about that have elected to enroll in Safeguard because of SAB-142's competitive dosing profile, even after Tzield has become available.

Speaker #3: , 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 this is only approved in the US for stage three .

Speaker #3: The majority of our sites are in Europe . , to 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 US who have .

Speaker #3: We've heard about that have elected to enroll in safeguard because of SAB 142 competitive dosing profile . Even after Tzield has become available

Speaker #11: All right . Great Thanks .

Kai Mackay: All right. Great. Thanks.

Speaker #3: Thanks

Samuel J. Reich: Thanks.

Speaker #2: Thank you . We'll move on now to Sima Sharon with Rodman and Renshaw . Your line is open

Operator: Thank you. We'll move on now to Seema Sharon with Rodman & Renshaw. Your line is open.

Speaker #12: 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 five and above ?

Seema Sharon: 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? I have a follow-up.

Speaker #12: And I have a

Speaker #3: 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.

Samuel J. Reich: Sure. We anticipate the step-down to pediatric patients this quarter, and full enrollment of the SAFEGUARD remains on track to be completed in Q4. The follow-up?

Speaker #13: Okay

Seema Sharon: Okay. Yeah. Considering that the Part B full enrollment will happen in Q4, and then the site activation and last patient in will drive your ability to lock and claim the database, how confident are you in delivering the top-line data in H2, which I'm assuming is going to be Q4?

Speaker #12: Yeah , yeah . So considering that the part be full enrollment will happen in fourth quarter . And then the site activation and last patient in will drive your ability to log and clean the database , how confident are you in delivering the topline data in second half , which I'm assuming is going to be fourth quarter

Speaker #3: Well , , you know , our guidance doesn't change as long as we , , as we are planning to complete enrollment and the Q4 of this year , we should have top line data in the second half of 27 .

Samuel J. Reich: Well, our guidance doesn't change. As long as we are planning to complete enrollment in the Q4 of this year, we should have top-line data in the H2 of 2027.

Speaker #12: Okay . That's helpful . One more question . , how is the price study powered ? That's my last question . Thank you

Seema Sharon: Okay. That's helpful. One more question. How is the PRISE-hATG ATG study powered? That's my last question. Thank you.

Speaker #3: I'll let Alexandra answer that .

Samuel J. Reich: I'll let Alexandra answer that.

Alexandra Kropotova: PRISE-hATG ATG study is the registrational trial. Therefore, adequacy powered to detect the difference between the active and placebo for the primary endpoint, which is the C-peptide at 12 months following the 2-hour MMTT. It's also powered for the key secondary point on the glycemic control in a similar manner as the SAFEGUARD trial.

Speaker #9: QT study is the registration trial . 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 2RMMCT .

Speaker #9: It's also powered for the key secondary point on the glycemic control . In a similar manner as the safeguard trial

Speaker #12: I see . So it's like 80% powered for at least 40% difference on C peptide .

Seema Sharon: I see. It's like 80% powered for at least 40% difference on C-peptide?

Speaker #13: Correct

Alexandra Kropotova: Correct.

Speaker #12: Okay . Thank you

Seema Sharon: Okay. Helpful. Thank you.

Speaker #2: Thank you . We'll move on next to Emily Bodner with H.C. Wainwright . Your line is open

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

Speaker #14: Hi . Thanks for taking the questions , have you commented on how many sites you're expecting to be included in the PRI study Just kind of curious on if timing for enrollment cadence could be similar to safeguard .

Emily Bodnar: Hi. Thanks for taking the questions. Have you commented how many sites you're expecting to be included in the PRISE-hATG study? Just kind of curious on if timing for enrollment cadence could be similar to SAFEGUARD. Secondly, with the Tzield approval now in Stage 3 Type 1 Diabetes, are there any aspects of the Tzield launch that you're tracking to kind of help frame the SAB-142 opportunity? Thank you.

Speaker #14: , and then secondly , with the Tzield approval now in stage three , are there any aspects of the launch that you're tracking to kind of help frame the SAB one for two Thank you

Samuel J. Reich: Alexandra for the first part, and I'll take the second.

Speaker #3: For the first question , the first part and I'll take

Speaker #9: So the price study has seven sites . four of them are in the US . And other sites are in Europe . The study are staggered versus safeguard .

Alexandra Kropotova: The PRISE-hATG ATG study has seven sites. Four of them are in the US, and other sites are in Europe. The study starts staggered versus SAFEGUARD, and the top-line results for the PRISE-hATG are expected in Q1 of 2029.

Speaker #9: And the total planned results for the price are expected in Q1 of 2029 .

Speaker #3: And for Tzield , we'll continue to monitor launch and how it progresses . But it's too soon for us to draw conclusions . There are recent quarterly disclosure likely reflects the pediatric expansion in EU approval in stage two , rather than stage three , which was just approved mid June .

Samuel J. Reich: For Tzield, we'll continue to monitor Tzield's launch and how it progresses, but it's too soon for us to draw conclusions. Their recent quarterly disclosure likely reflects the pediatric expansion and 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.

Speaker #3: More importantly , T-cells 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

Speaker #2: Thank you We'll move next to . Kumar Rakha with Brookline Capital Markets . Your line is open .

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

Speaker #15: , thanks for taking my questions . I just had one follow up on the number of sites . , given that for the price study or planning seven sites , , how do you think you will be able to enroll so quickly ?

Kumar Raja: Thanks for taking my questions. I just had one follow-up on the number of sites. Given that for the PRISE-hATG study you're planning seven sites, how do you think you'll be able to enroll so quickly if the number of patients are much larger? Then I had a question on SAFEGUARD. What are you seeing there in terms of screening failure rate? Thank you.

Speaker #15: Is 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 .

Speaker #15: Thank you

Alexandra Kropotova: Excellent question on the enrollment. As we already mentioned, PRISE-hATG 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. 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.

Speaker #9: Excellent question . 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 .

Speaker #9: 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 .

Speaker #9: ...highly interested in this clinical trial. And that enables a very efficient enrollment over a smaller number of sites.

Speaker #3: 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

Samuel J. Reich: 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.

Speaker #15: Okay . , and in terms of drug supply , where do you stand with regard to that ? Thank you

Kumar Raja: Okay. In terms of drug supply, where do you stand with regard to that? Thank you.

Speaker #3: We have sufficient supply to support both trials.

Samuel J. Reich: We have sufficient supply to supply both trials.

Speaker #15: Okay . Great . Thanks so much

Kumar Raja: Okay, great. Thanks so much.

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

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