Good morning. I am Sam Semenkow. I am one of the Senior Biotech Analysts here at Citi, and it is my pleasure to be hosting SAB Bio at Citi's 2026 Biopharma Back to School Conference. I am joined by Sam Reich, CEO, and Lucy To, CFO of SAB Bio. Sam, Lucy, welcome, and thank you so much for being here.
Thank you for having us. It is a pleasure.
Why don't we just maybe start off at a little bit high level. You have made a ton of progress advancing SAB-142 into a pivotal study. Could you just maybe level set where the company stands today and what we can expect throughout the end of the year and even next year?
Yes. We have been focused on execution of the SAFEGUARD study this year, and have really dialed down to make sure the whole team is laser-focused on that study, and it is going very well according to plan, and we are still looking forward to announcing last patient in in Q4 of this year.
Excellent. Looking forward to that, too. On that note, maybe we start with enrollment. Obviously, it remains on track because you just guided that and confirmed it. More than 60 activated sites. What have been the biggest drivers of the acceleration that you've spoken about seeing and screening in both randomization activity?
Driver number one is getting sites activated and online, and that happens in a staggered fashion. They don't all come up on day one. So throughout the course of 2026, we've been bringing more and more sites online to now well over 60 sites enrolling. The second major driver is stepping down to younger patients and increasing the patient population that we can enroll. As those two things combined, enrollment accelerated, momentum built, and we're pleased with the rate of enrollment we're getting.
The pediatric patients are already being enrolled?
Yes.
Got it. Okay. Can you frame the importance of that population, the pediatric population, to the eventual commercialization opportunity, as well as the regulatory package for SAB-142?
Well, for the commercial opportunity, we want this drug to be available to all the patients affected by T1D, and many, as much as half of the diagnoses are in patients under 18 years old. It's a very important population. From a regulatory standpoint, we certainly need to study those age groups. I think another important factor is the behavior of the disease in the different age groups, which is that the younger the patient, the more aggressive the disease is. It's also very important for the trial to have the diseases stratified to have the placebo group behave the way we want.
Can you say a little more about that placebo arm? What are you looking for from a pediatric perspective versus an adult population?
Yes. The primary endpoint is C-peptide at 48 weeks, and we're looking to show preservation of C-peptide. In order to prove that statistically with this number of patients, we need the placebo patients to be losing C-peptide at a certain rate. Younger patients lose C-peptide faster than older patients. But we want to treat every patient, and the drug should work the same in each age group. In order to address that entire age range, which for SAFEGUARD is 5 - 40, we need to study every age group, but we need to make sure we have enough pediatric patients and young patients in order for the placebo to act according to the model and to hit significance on our primary endpoint, which is C-peptide. Yeah.
From a statistical perspective, you analyze these populations separately. Is there an overall analysis that is secondary, or how should we think about the hierarchy here?
The primary endpoint is that total population with that entire age group, which is roughly a third of 18 to 40, 12 to 17, and 5 - 11. It is roughly a third, a third, a third. But we have capped adults, so we will not enroll more than 45 adults, which is 15 per group. And we have no cap on the youngest patients, so we can keep enrolling as many of them as we want. And what was the second part of the question?
I think you answered it.
I answered it, okay.
I think you answered it. So no, I understand your point, then. So you need the right amount of pediatric patients to support your modeling for that total population. Understood.
Correct.
Okay. FDA is now accepting C-peptide preservation as a surrogate endpoint in type 1 diabetes, which is incredibly positive for you. As you talked about, that is your approval endpoint. Is there anything else besides hitting positively in SAFEGUARD that you need to support a potential accelerated approval strategy?
Yeah. A couple of points. One is that the KOLs, the academics, they bristle at the term surrogate endpoint because what we're trying to do is preserve beta cells, and this is the endpoint for showing preservation of beta cells. With the TZIELD approval in stage 3 this summer, and with our own communications with FDA, we know that hitting on C-peptide as your primary endpoint is acceptable to the FDA for an accelerated approval, which is great to know, but our plan proactively has always been for full approval. For full approval, which we know from FDA, it is explicit, the FDA wants to see a clinical endpoint. So we have as our key secondary endpoint, HbA1c. Reduction in HbA1c in addition to C-peptide is sufficient for a full approval, which is our plan.
Our plan is to get a full approval. In the previous THYMOGLOBULIN studies, which include the TN-19 and the MELD study, HbA1c was significantly reduced. So in two previous studies, the same mechanism of action, a drug we behave similarly to, showed a reduction in HbA1c. So we hope to show HbA1c both because we have the same patient population, but we have more patients in each arm. In addition to that, we're redosing so that there will actually be more drug pharmacologic activity through the course of the 48-week trial. To fully answer your question, FDA is not married to HbA1c. They want to see a clinical benefit. Some of the other secondaries we're looking at, any of which would work, and it would be great to hit multiple, even though HbA1c is our secondary, our key secondary.
Other secondaries are insulin use, frequency of hypoglycemic events, time in range, which is measured by the patients now today, and in our trial, all wear continuous glucose monitors. So data is captured for how much time they spend in the normal glucose range. If patients spend more time in the normal glucose range, that's a meaningful clinical endpoint. So there are a series of clinical endpoints, any of which would be sufficient for a full approval.
So then, data dependent, let's say you preserve C-peptide as you expect. You hit on one of those minimum. You would take that to FDA for a full approval package. If you, I mean, unlikely, but if you didn't hit any of those secondaries in the context of C-peptide preservation, accelerated approval still remains on the table for you as a pathway.
Yes. At that point, you can file for accelerated approval, get the drug approved, with the agreement with FDA that you will subsequently show a clinical benefit.
Right. Understood. Okay. So that's great. When we see the data, second half of 2027, I believe, is what you've guided for top-line SAFEGUARD data. Those are the two we should be looking for, C-peptide, of course, and those secondaries, and that will really determine your next steps regulatory-wise.
Correct.
When you think about translating that potential data, you already have some data showing C-peptide was preserved for patients that were treated with SAB-142, and some even saw an increase in C-peptide. Small numbers, but I think it's encouraging. When you think about that being replicated and SAFEGUARD, how should we think about translating that data into the larger population, when you move into the commercial landscape, and how should we think about durability beyond 48 weeks?
Thanks. The data we got in phase I was very encouraging. It is four patients, but it is certainly an encouraging sign and a very compelling evidence of proof of concept. The program is based on data from the TN-19 study, the design of the trial, and the patient population. Our basic expectation is that the drug will look very similar to the TN-19 results, which again was preservation of C-peptide and reduction in HbA1c. When you look at four patients, you do not have the mean with the variability of 150 patients, and with different patients at different ages and with the variability in C-peptide. Even though we saw an increase in phase I, it is more likely to look like TN-19, which is a preservation. With that said, we have the ability to redose, and that should give the possibility of a flatter line in the treated group.
For the commercial profile, if we hit on HbA1c, you have a redosable drug. Part of your question was redosing. In addition to part of SAFEGUARD that we have not talked a lot about is the long-term extension study. Every patient in SAFEGUARD, if they finish, if they go to their 48-week study visit, will be eligible to continue to get SAB-142, and that is for another year. Those patients that continue will get two more doses. The drug is dosed every six months, so at the end of 24 months, they would have had four doses, and we will have two-year data. That two-year data in those patients in the LTE, long-term extension study, will be proof and data to support continuous dosing. If you think about the commercial profile, we believe we will have a drug that a patient could take for their entire life.
The durability of the drug is that at some point, the effect wears off, and patients start to lose C-peptide. We have seen that with all the other drugs. They do not last forever. The benefit of that T-cell activation wears off, and patients need to get redosed. TZIELD, there is no data to support they can be redosed, and there is a lot of anti-drug antibodies, and that is not on label. But with our LTE and our mechanism of action, as well as our lack of immunogenicity, coupled with the patient's need for continued preservation, if a patient is responding to the drug, they will likely continue to get the drug. That dramatically changes the commercial profile because you now have a drug, and you are accumulating patients every year that continue to stay on drug and get dosed every six months.
What does that actually look like? If you could put some numbers on it. I hear you. You are just growing the market year over year as you gain new patients, as they become incident. What does that actually look like number-wise if you could just frame the opportunity?
Lucy To, do you want to talk a little bit about that?
We believe it's a huge commercial opportunity, multi-billion. Conservative estimates put it around $4 billion just in the U.S., just for SAFEGUARD. Not everybody is going to be eligible. It's based on time of diagnosis and residual beta cell. If conservatively $4 billion in the U.S. If you just look at teplizumab being priced at $356,000 for the year, there's certainly upside to that number, then obviously upside to the PRIZE study, right? We're going to be looking at patients, be studying patients up to two years. So that 64,000 number becomes doubled, then you redose, the numbers get pretty big pretty quickly. We have a huge barrier to entry with our Transchromosomic cows. We have a very good IP position, where we don't believe that we will have a patent cliff. So could possibly be single to double digit billions.
Of course, we have to run through the study and everything else. We believe it's a huge market.
I'm going to put out a hypothetical here. Let's say your durability comes out at five years. Even that is still a massive opportunity for this drug when you think about the compounding effects of the market size.
We would agree.
Okay. We'll see that. We'll see that in the data over time. Okay. When you speak with endocrinologists, what is on their wish list for a therapy like SAB-142 that could prevent the progression of Type 1 diabetes, and how do they think about the target profile that they want to see you achieve to maximize their interest and how they would use SAB-142?
Well, I think I need to start the answer by perhaps stating the obvious, which is that the first wish on everyone's list is to make a patient insulin-free. That's what we're all going for. With our drug, if you address the patient in stage 2, which is our next indication we're going after, with the ability to redose, we offer the possibility of keeping patients insulin-free. I think more and more patients will get diagnosed at stage 2 over time, and the ability to have an effective and redosable drug and treat a patient when they have enough beta cells that they don't yet need insulin, you could keep those patients at a beta cell count where they don't need insulin. So that's got to be said when we talk about Type 1 diabetes.
Next, the wish list for a stage 3 patient, of course, which is our initial indication and means that the patient already needs insulin, is making their diabetes easier to manage. So diabetes is a constant day-to-day, hour-to-hour struggle with diet, exercise, sleep, insulin treatment, hypoglycemic events. The first thing on the doctor's wish list is, let's make their life easier. Which is borne out by the data in long-term studies. If you preserve beta cells, then everything else is better. If you have enough power, there's the EDICT study and the DCCT study and the ToMI study. More beta cells in any patient means an easier life and easier day-to-day management of the disease. The next thing I would say is the convenience of dosing, because patients now very recently have the availability of TZIELD. That's a two-week course going over one week.
Doctors are saying, "We need something that's more convenient." We have, with SAB-142, a drug that can be dosed in two days, which is a dramatic improvement. If you get it every six months, it's a total of four days a year. If you think about other biologics and other infused drugs, and you think about it in four days a year, that's a very attractive, reasonable product profile and burden on the patient. Four days a year to preserve beta cells is considered by the KOLs also very attractive.
On safety and tolerability, what has that data shown so far from your phase I study?
We think we'll have an attractive AE profile, and what we're seeing so far looks like it'll be competitive, if not the best AE profile. Of course, it's early days, but that was what we're seeing in phase I, and it should be very competitive.
Then just from a commercial strategy perspective, as you look forward and think about launching 142, how will you go about actually initially targeting this population? Is it at academic centers? Obviously, patients are treated very broadly in their community endocrinologist offices. Is it a referral network then that you need? What's the strategy to get this to the most patients that you possibly can?
Well, certainly the KOLs and the academic institutions first. In the pediatric population, the vast majority are immediately referred to an academic institution. The first approach to addressing the market is to be at academic centers. That is something you could address with the field sales force of 50 reps. Very easily addressed. That is the first market. Yet we do not want to ignore the community. When market research has shown that when you get to adults, more are not getting to an academic center. We are still thinking about that and working that through. The lion's share of the focus will be at KOLs and having some operation in place that does not ignore the community.
I think we must say that a huge component of this in this indication is medical education will be addressed by medical affairs and MSLs and doing a lot of education for everyone, which addresses the community aspect of it, or not at a KOL aspect, about the need to treat patients and the benefit of preserving C-peptide and the benefit of redosing. Because if a drug cannot be redosed, something doctors need to know is if you are preserving their C-peptide, they are going to want to keep preserving C-peptide. That is the basic strategy. It is early days, but market research already shows from TZIELD that, and we have heard from doctors.
Sanofi is sort of trailblazing here, and I think we have a second comer advantage because they are doing a lot of the heavy lifting, a lot of the medical education, getting used to doctors prescribing, getting used to infusions. They are doing 12-day infusions, so the practice of getting a patient an infusion, Sanofi is leading the way, and we can follow that, which I think is a huge advantage. We have heard from doctors that now, today, which they would not have said a year ago, they would consider it malpractice to not tell a patient that these drugs are available when they get diagnosed at the time of diagnosis.
Right. These drugs are that important. This field is that important, for sure. Okay. That is very helpful context for how we should think about the commerciality of SAB-142. Lucy, you mentioned the PRIZE trial in passing, but I want to spend some time on that. It is designed to evaluate the patients up to two years from diagnosis, and we know that there are patients that have C-peptide preservation through that time point. So, to your point, it builds on that population for SAFEGUARD, and that was only 100 days from diagnosis. Just maybe to put a finer point on, I think what you were alluding to before, how much does that expand the commercial opportunity for SAB-142 if successful?
I think initially, when we file an sBLA for that patient population, it should double the 64,000 patients, so 128,000 patients just initially that first year. Whatever market share you want to take off of that. Then they'll be redosed, and then after that, it'll be 64,000 patients every year. But you'll get an initial bolus of the market opportunity, I guess sort of overnight once we get the label expansion for that patient population.
If you consider it in the context of just the current market, having a time clock on when you get diagnosed is a barrier. You could imagine a scenario where a patient has just gotten diagnosed with this disease, is just learning about how to use insulin, and then they're being presented with this option of getting this drug that has to be infused, and there's a clock, and you have 100 days. Well, if that clock goes away and now a patient has a year, that's just more penetration of the market that already exists because patients have more time to decide.
Right. That flexibility is really important from both a patient and even a timing to get into that endocrinologist office perspective for some institutions. We've talked about this, Sam, but that 100 days post-diagnosis is frankly arbitrary, right? It was chosen to make an ease of clinical trial. Is that fair? And what data do we have to suggest that post 100 days there's still C-peptide too that is available to be preserved?
Yeah. Well, the idea that it's arbitrary is discussed. I don't know if we can conclude it, but the KOLs largely think that it's arbitrary. When all of us design clinical trials, we want to find ways to narrow the patient population and make it as homogeneous as possible to increase the likelihood of success. However, patients by and large do still have C-peptide after 100 days. We can still preserve C-peptide. We know that from other trials, and our four patients in our phase I were well out past two years. And we'll prove it in the PRIZE study. So we'll answer the question definitively, which will say this 100 days was arbitrary. I think it's also to point out that TZIELD has eight weeks on the label, 56 days.
We are already increasing the opportunity with 100 days, and then when you go to the question was about the arbitrariness. The specific purpose of the PRIZE study was to prove that concept. It is Michael Haller's study. He designed it. He was interested in it. Breakthrough T1D was interested in funding it. The PRIZE study is a grant award to Mike Haller from the Breakthrough T1D. That was a huge question. Is it arbitrary? And that is why the study is designed the way it is the control group is patients within the first 100 days. Cohort 2 is 100 to one year, and cohort 3 is one year to two years. So it is specifically designed to prove that point that it is arbitrary, and successful results will establish that.
Yeah. Looking forward to it. And the PRIZE and SAFEGUARD, they are very similar trials, other than that time from diagnosis and of course, site number and things like that. But if SAFEGUARD works, particularly if you hit on both the primary and some of the key secondaries, how much does that impact your confidence that PRIZE will also read out positively given the hypothesis that 100-day cutoff is not necessary?
Well, tremendously, because now you are working with a drug that has been demonstrated to be effective. I think the question is still there until you get the results. But I think SAFEGUARD working is a prerequisite. So when you have demonstrated that, it makes the risk of PRIZE go down dramatically, but we consider it a win-win, right? SAFEGUARD is our trial to prove efficacy and get the drug approved, and it does not rely on PRIZE. But if PRIZE hits, we are just expanding the market with really no downside risk.
Yeah. I think it is great. I want to switch gears a bit maybe and talk about a topic that is perhaps near and dear to your heart, your Tc Bovine platform. You have recently announced that you began construction on a second South Dakota facility to really establish a redundant herd. Maybe just talk through the platform a bit, some of the advantages there, some of the IP benefits that you have alluded to, and the most important strategic benefits of this investment as you move closer to commercialization.
Yeah. Our platform is Transchromosomic cows that are all clones, and they are genetically engineered so that they make human IV IgG, and they become plasma donors for human IVIg. The advantage of a cow, which doesn't exist in humans, is we can give them vaccinations for a drug target and produce a targeted IgG that's fully human. THYMOGLOBULIN, which is our sort of reference comparator, is a rabbit IVIg that's made by vaccinating rabbits with human thymocytes, and you have a rabbit anti-thymocyte IVIg product that has the downsides of serum sickness and the inability to redose. You cannot redose that product. Our cows allow us to make the human version of that drug that we know is effective, and that is incredibly powerful platform.
The advantage, again, is no serum sickness and the ability to redose, and we've talked today about the ability to redose and chronically dose these patients. Our cows are plasma donors of human IVIg, and because they're cows, we can target them. From an IP perspective, I think it's pretty easy to understand that we effectively have IP into perpetuity because we have multi-level IP protection, which includes trade secrets, which in IP 101, by the way, is the most valuable form of IP because there's no expiration. Nobody knows it. Patents expire. We will have patents on the drug that will expire in 20 years, but we have the cows, the trade secrets, the knowhow to make a cow. In addition to that, there's no biosimilar pathway for plasma-derived IVIg.
You'd also have to start from IND, and it would be a new molecule, not a biosimilar. The combination of those three is a very attractive IP or exclusivity package that I think is very uncommon in biotech.
Agreed. Just the redundancy of that second herd allows you to further shore up the manufacturing ability.
Right. To address the investment in the second farm, these cows are very valuable to us, and there is some outside risk that something catastrophic could happen, God forbid, which would either be some kind of an outbreak or a weather event. Our first risk mitigation strategy had been, and continues to be stockpiling plasma. We can stockpile plasma, and it's stable for 10 years. We can make much more than we need. The redundant farm allows us to have a redundant herd so that if something were to happen to one herd, we always have cows at another facility ready to be plasma producers.
South Dakota was chosen on purpose, right?
South Dakota is considered to be the state with the sort of climate and infrastructure that's the most friendly for cows. It has the most cows per capita of any state in the U.S. When we needed, and continue to need all the infrastructure that goes into housing cows, South Dakota is the place to be. I will point out, since we're talking about it, that to contextualize what the operation is like, it is akin to a dairy farm. The cows are dairy cows, and they're housed and fed and treated just like a dairy.
Excellent. Just beyond SAB-142, I'm wondering what other opportunities exist to leverage a platform across other autoimmune diseases or immunological indications, and how should we think about broadening it beyond type 1 diabetes?
Yeah, that's a great question. If we start with the human IVIg business and look at companies like CSL Behring, that's a $20 billion business at a much lower price point, and you can only get basically general IVIg that exists in the human population. When you look at the animal IVIg drugs, there's about 12. THYMOGLOBULIN is the biggest one. They're highly limited because they can't be redosed, and they make the patient sick, so they've been used very scarcely. We have an animal in which we can make human IVIg, so that's a huge unmet market and opportunity that we can tap into, and no one else can. Today, the company is laser-focused on being a type 1 diabetes company, and as our SAB-142 program matures, we will expand to other autoimmune conditions, firstly, that are addressable by SAB-142.
SAB-142 is a drug that confers tolerance without immunosuppression, and that's important for many autoimmune diseases, T-cell-mediated autoimmune diseases. While today we are focused on the type 1 diabetes program, as that program advances, the first thing we'll do is look to expand the label and make SAB-142 available in other autoimmune indications. I think the market opportunity goes beyond those big numbers that are already in T1D, and this really will become a big franchise product.
Got it. Okay. Well, I think we've been quite efficient with our time. I'm going to turn it back to you, Sam, for any closing remarks you may have, and then if you could just also remind us your cash runway and recap what we should look forward to over, say, the next 12 months.
Sure. I think we have a very exciting opportunity here at SAB. We're the next in line to be a leading T1D company, and our mission is to transform what it means to get diagnosed with T1D. Up until today, it meant you need insulin and you need CGM, and now with the advent of TZIELD, but with the advent of our drug, it's about preserving the organ, and if you catch it early enough, becoming insulin-free at some point. We are looking forward to announcing the trial being fully enrolled by the end of the year, and very excited to share top-line data at the second half of 2027. So keep an eye on it, and I'll let Lucy take it from there with cash runway.
With cash, we ended the last quarter with $208 million of cash, so that gets us to the end of 2028. That should see us through the SAFEGUARD data, the initiation of PRIZE, and pre-commercial activities and manufacturing activities. That does not include our enrollment tranche that we expect, perhaps the end of this year, early next year. Those expire 30 days once we fully enroll SAFEGUARD. We have a pretty good cash runway to see us through the data point.
Excellent. Well, this has been wonderful. Thank you both so much for the time, and yeah, thank you.
Thank you. Thanks for the time.