Good morning, everyone. Welcome, and thank you for joining us. My name is Doug Gibberdini. I'm an associate on the healthcare team at J.P. Morgan, and today I have the pleasure of introducing the SAB Bio team. I'm joined by Chief Executive Officer Sam Reich. As a quick reminder on format, this will be a 20-minute presentation followed by 20 minutes of Q&A, so please save all questions for the end of the presentation. And with that, I'll pass it over to Sam. Thank you.
Thank you, David, and thank you to J.P. Morgan for hosting us today. My name is Sam Reich. I'm the Chief Executive Officer of SAB Bio. During this presentation, I will be making forward-looking statements. At SAB Bio, our mission is to redefine what it means to receive a type 1 diabetes diagnosis by developing new treatments to change the course of disease and not just treat the symptoms. Let me introduce SAB Bio for those of you less familiar with us. We are a clinical-stage biotech company developing a human anti-thymocyte immunoglobulin for type 1 diabetes. Our drug, called SAB-142, is in late-stage clinical development in a pivotal phase II-B to delay the progression or even halt the onset of the disease.
Our company leverages a technology platform which allows us to have multi-level intellectual property protection, which includes patents, trade secrets, and the fact that there is no biosimilar pathway for this drug modality. Type 1 diabetes is a multi-billion-dollar market opportunity and a major unmet medical need. The company has capitalized to fully fund a phase II-B trial with a syndicate of investors that are top-tier biotech specialists. SAB is led by a management team and a board of directors with deep and broad expertise and a proven track record of success in biotech, which includes global clinical development, regulatory strategy, as well as commercialization. Therefore, we believe we have all the ingredients for significant value creation, as well as, more importantly, a significant impact on patients and families affected by type 1 diabetes. 2025 was a pivotal year for SAB.
It was a year in which we released top-line positive results from a phase I clinical trial, which allowed us, on the back of that, to capitalize the company to fully fund a pivotal trial. We announced that we started that trial, and we capitalized the company to fully fund it. Our goal in 2026 is to focus and execute and complete enrollment by the end of the year, which will allow us to have data from our pivotal study by the end of 2027. So SAB has a wholly-owned platform technology, making us the only company in the world that can make specifically targeted, fully human immunoglobulin drugs. This technology is a TC Bovine or a transchromosomic cow. It is a cow that has had its bovine IgG genes knocked out and gets a human artificial chromosome with the full repertoire of human IgG genes.
The result is a normal, healthy cow which has a functioning immune system, but the immune system is mediated by human IgG, and the cow becomes a donor for fully human IgG products. In the case of our lead product, SAB-142, we vaccinate the cows with human thymocytes, purify the IgG from those cows' plasma, and the resulting drug product is fully human anti-thymocyte immunoglobulin. So type 1 diabetes, our first indication, is an autoimmune disease which is characterized by a patient who has autoantibodies attacking the pancreas and the beta cells where insulin is made. This disease can strike anyone at any time. It affects both children and adults with an average age of diagnosis of 13 years old. So a type 1 diabetes diagnosis is a life-altering diagnosis which leads to many long-term complications, which include diabetic retinopathy, the loss of vision, diabetic nephropathy.
They can lose limbs and have kidney failure, all of which lead to a shorter life expectancy. While there is insulin management, that is just managing day-to-day symptoms. It does not treat or alter the course of the disease. Today, type 1 diabetes can be diagnosed in multiple stages. Stage 3 is the largest market opportunity where over 90% of patients are diagnosed, and that is our first indication. With the advent of screening for autoantibodies, patients can be diagnosed prior to clinical onset, and stage 2 is a patient with autoantibodies that has begun to have some dysglycemia, and that patient is going to become stage 3 or have clinical onset imminently. That is another point of time in which we can intervene and treat the disease. So type 1 diabetes is a major unmet medical need and a multi-billion-dollar market opportunity.
Today, there are close to 10 million people affected by type 1 diabetes. There are 64,000 new patients diagnosed every year in the U.S. alone. There is the first drug approved, which is called Tzield. It is a monoclonal antibody for type 1 diabetes. Today, it is only approved in stage 2, that smaller market, and with that approval, Sanofi acquired the company developing Tzield for $3 billion. So SAB-142, our lead compound in development, is a fully human Anti-Thymocyte Immunoglobulin. It is a drug which engages T cells and modulates the immune system to create tolerance to self and tolerance to the pancreas. And our goal in this indication is to use a drug that preserves beta cell function and preserves the patient's ability to make their own insulin. There is no substitute for a patient's own insulin.
This is a drug that has a clinically validated mechanism of action. There is a drug which is a fully rabbit anti-thymocyte globulin , which has proven to be efficacious in type 1 diabetes but is encumbered by safety liabilities that make it not suitable for use in this patient population. I'll talk about that clinical validation now. Rabbit ATG, also known as Thymoglobulin, is approved in the global standard of care in organ transplant. Diabetes researchers began to study Thymoglobulin in diabetes patients because of its engagement and activity on T cells, and type 1 diabetes is a T cell-mediated autoimmune disease. In 2013, when the first studies were conducted in diabetes patients, the organ transplant dose, or a high dose, was used in a trial with newly diagnosed patients, and the results were disappointing, but there is evidence of efficacy in the dataset.
And in 2018, a pivotal study was conducted at a lower dose of Thymoglobulin, or rabbit ATG, with remarkable positive results, creating a lot of excitement. Low-dose Thymoglobulin, or rabbit ATG, showed preservation of C-peptide, which is the accepted marker of beta cell mass and function, as well as reduction in HbA1c, showing that this mechanism of action worked to both preserve the organ as well as increase glycemic control. This was a pivotal study, and it was the foundation of our program because, again, this drug is encumbered by safety liabilities, which include serum sickness, making the patient sick, and immunogenicity, so that this drug can only be dosed once, and this is a lifelong disease that requires chronic dosing.
This September, an additional study in patients newly diagnosed with Type 1 diabetes, called the MELD study, was published in The Lancet, in which an additional patient population and another study, Thymoglobulin, proved efficacious. Once again, it showed that it could preserve C-peptide as well as improve glycemic control in the patients. With these data, in 2024 and in 2025, we announced a successful result of our drug, SAB-142, a human anti-thymocyte globulin, which was that we had solved the safety problems by using a human drug, a human IgG, so that we did not show any serum sickness. We showed that we can reliably redose and that our drug has the same mechanism of action as Thymoglobulin, so we can be confident that the drug will exhibit similar efficacy to Thymoglobulin.
Our phase I study was designed to show that we had solved the safety problems, that the patients do not get serum sickness, that the drug is not immunogenic and can be reliably redosed, and that it has an acceptable safety profile for this patient population, and that the drug exhibits a mechanism of action analogous to rabbit Thymoglobulin, so we can be confident about the drug's ability to be efficacious. The results of the study were a success. We saw the result that we were hoping for. There was no serum sickness in any patient. There were no drug-related SAEs. The drug was not immunogenic and could be reliably redosed. Importantly, the drug exhibited that mechanism of action, which we'll talk more about, which drives efficacy and preserves beta cells.
The figure on the right is a profound lymphopenia that resolves rapidly to baseline, which is the on-target activity effect of the drug. So when you see this sign, you know the drug is actively engaging T cells, activating them, which leads to the exhaustion that drives efficacy. And importantly, here, what we see is that the activity is unimpaired upon redosing, demonstrating that the drug can be safely and reliably redosed. So let's talk about the agents that have proven efficacious: our competition, Tzield, which is a monoclonal antibody against T cells, Thymoglobulin, our reference molecule, as well as SAB-142. On the top row, we see the commonality between these drugs, which is inducing CD4 exhaustion. That induction of durable CD4, or T cell exhaustion, results in C-peptide preservation. Tzield, Thymoglobulin, and our drug all lead to durable T cell exhaustion.
Now, Tzield has shown preservation of C-peptide, met the primary endpoint, and is efficacious, but they have not shown the ability to improve glycemic control. They have not yet shown a reduction in HbA1C. Thymoglobulin, the compound analogous to SAB-142, shows both C-peptide preservation as well as a reduction in HbA1C, which has improved glycemic control. With these results, we can conclude that thymoglobulin is a superior mechanism of action. SAB-142. So what is the difference in the mechanism? Tzield does not preserve Tregs. Tregs are critical for self-tolerance. So having a negative impact on Tregs is a counterproductive mechanism of action, and a key difference between thymoglobulin and SAB-142 versus Tzield is that our drugs induce exhaustion while preserving Tregs.
Because SAB-142 is common in that it does CD4 exhaustion while preserving Tregs, we are confident that we will have an efficacy similar to Thymoglobulin, more similar to Thymoglobulin than Tzield. Additionally, Thymoglobulin and Tzield both lead to lymphodepletion. They're both immunogenic and can only really be dosed once and cannot be redosed again, and this is a chronic disease, and SAB-142 induces T cell exhaustion, preserves Tregs, but can be given without causing serum sickness and can be reliably redosed for the life of the patient, which is essential, and therefore, we're confident we have a best-in-class product. In addition to that, there is an important differentiation between Tzield, Thymoglobulin, and our drug. Tzield requires 12 days of continuous dosing, and that is a significant dosing burden to put on the patient and a logistical challenge.
Thymoglobulin can be given over one to two days in an outpatient setting, and SAB-142 can be given two days in an outpatient setting. So were the drugs to have similar efficacy, SAB-142 would win on the dosing regimen alone, and on top of that, it is also expected to be, based on thymoglobulin, a superior mechanism of action leading to superior efficacy, and therefore, we're confident we have a best-in-class product. Today, we are currently enrolling in a pivotal phase II-B trial. We have agreement with the FDA that this is a pivotal study. It's called the SafeGUARD study. It is a study in newly diagnosed type 1 diabetes patients, age five to 40 years old.
There are 159 patients stratified by age and broken into three arms: a high dose, a low dose, and placebo in a one-to-one randomization, and we believe both our doses are active. The primary endpoint is stimulated C-peptide at one year, and one of the important secondary endpoints is HbA1C at one year. This is a global clinical trial being conducted in the U.S., Europe, U.K., and Australia. And the drug in this trial will be given every six months. So we have a strong balance sheet. The company is fully funded through the SAFEGUARD trial with a runway beyond that, and we collaborate with the world's leaders in patient advocacy and philanthropy for type 1 diabetes, which allows us to have global excitement for this product, a lot of enthusiasm, and a desire to have patients on our drug.
So we want to make it clear that while we are having our first indication be Type 1 diabetes, that this drug is not diabetes-specific. What SAB-142 does is create self-tolerance without immunosuppression. So we believe that when we validate and show efficacy data in the SafeGUARD study, that it will be clear that this drug will go on to get approved in other unmet medical needs and autoimmunity. This is truly a pipeline in a product, and this drug has franchise drug potential. So we have a lead compound in late clinical development and a pivotal study with a clinically validated mechanism of action in a major unmet medical need and a multi-billion-dollar market opportunity. We leverage a platform giving SAB-142 long-term exclusivity, and we have a management team with the track record to execute and be successful.
Therefore, we believe that SAB has all the ingredients to drive significant shareholder value and, more importantly, make a significant impact for patients and families affected by type 1 diabetes. Thank you very much.
Awesome. Thank you, Sam.
You're welcome.
I can kick things off here with a couple of questions. Obviously, it's been a huge year in 2025 with the initiation of the SafeGUARD study. I'd love to hear more about how enrollment and dosing are going. I know the first patient was dosed not too long ago.
Yeah, so we announced the first patient enrolled in mid-December. It's mid-January, but we have multiple jurisdictions and multiple sites open, and we're very encouraged by what we're seeing so far and hope to be able to give enrollment updates throughout the year.
Let's delve into the clinical strategy. Why is C-peptide the preferred endpoint?
Our primary objective when intervening with this disease is to preserve the organ being attacked. Beta cells of the pancreas are where insulin is made. T1D is a disease in which the patient is not tolerant to its pancreas, and C-peptide is the accepted marker of beta cell mass and function. For a drug to be successful in this indication, we need to preserve beta cells. We need to preserve the patient's ability to make their own insulin, and the measure of that is C-peptide.
Great. Thank you. And I guess I know it's pretty far out from now, but I'd love to hear what the company's expectations are for the readout in the second half of 2027.
We have expectations that the efficacy will look similar to Thymoglobulin, and if we are able to show that we preserve C-peptide and improve glycemic control, we'll have a very competitive differentiated product with an excellent safety profile as well as the ability to redose the patient long-term. We do want to mention that Thymoglobulin can only be dosed once, and this is a chronic disease, and we are able to reliably redose the patient, giving us something that no other agent in this disease has, to preserve their beta cell function for their lifetime. In the SafeGUARD study, we will be redosing every six months, which gives us some ability to hope we have even better results.
Shifting to the regulatory framework, I'd love to hear how the interactions are going with the FDA.
So at this stage of our drug development, we have had a Type B meeting. We have an open phase II-B in the U.S., and the FDA has agreed that SafeGUARD can be a pivotal study.
I know you delved a lot into the commercial opportunity of type 1 diabetes. I'd love to hear specifically about how you view stage 3 patients.
Stage 3 patients?
Correct.
Stage 3, there are over 64,000 new patients diagnosed in the U.S. alone every year. These are all addressable patients for SAB-142. There's no drug available today. So we feel very good. We'll have significant market penetration.
Is there a subset of patients that you see SAB-142 specifically addressing in the current treatment paradigm?
Not specifically. To date, with the data we have today, we expect it to be efficacious in any newly diagnosed patient and also patients in Stage 2. Stage 2 is a much smaller market, and it's a larger and it's a much harder-to-find patient today. But treating a patient in Stage 2, Stage 2 patients do not yet need insulin. When we are able to intervene in Stage 2 patients, that offers the promise of preventing a patient from needing insulin indefinitely, and that's sort of the Holy Grail. We believe over time, with intervention possible, more and more patients will get approved and will get diagnosed in Stage 2, and Tzield is approved in Stage 2.
So as we're developing the drug in Stage 3, we'll begin to study it in Stage 2 and hope to have that label expansion and offer patients the possibility of not developing clinical diabetes and being insulin-free.
Taking a step back, where do you see the greatest unmet need?
This is a major unmet medical need. Insulin alone is not a therapy. There is a tremendous amount of urgency and desperation in this patient population because when a patient gets diagnosed, their life changes. They have a huge day-to-day management burden, fear and likelihood of developing long-term borderline catastrophic complications, and overall a shorter life expectancy, so this is a huge unmet medical need that is only today being addressed with the advent of Tzield, and our agent is next in line, and there's a lot of excitement about it, and we believe that we'll have a very competitive product.
Assuming Teplizumab gets approved for stage 3, what do you think are the competitive implications for 142?
So 142 can be reliably redosed. It doesn't cause serum sickness. Based on the clinically validated mechanism, we believe we will show reduction in HbA1C and have a very competitive product.
Awesome. And I guess shifting away from the clinical side, what are your expectations for your current cash runway?
So we have cash through 2028, and if we remain on track, which we believe we will, that's a year past the data readout.
Any current business development opportunities that you guys are thinking about?
We're certainly flexible and open, but we're laser-focused on developing SAB-142 and getting it to market as soon as possible.
Yeah. And I guess it'll probably be 142, but I'd love to hear what you're most excited about in 2026.
In 2026, I'm excited about hopefully seeing a Sanofi approval, focused execution on enrollment and keeping enrollment updated, as well as sharing any new exciting data we may have collected so far.
Great, and I'd love to open it up to the audience for any questions, and that concludes our presentation. Thank you, everyone, for attending, and thank you, Sam and team, for taking the time. Have a wonderful rest of your day.
Thank you. Thank you.