SAB Biotherapeutics, Inc. Common Stock Citigroup’s Biopharma Back to School Summit 2026
Review the key takeaways and the transcript of this earnings call.
- SAB Bio is focused on executing the safeguard pivotal study for SAB 142, targeting last patient in enrollment by Q4 2026 and top-line data in the second half of 2027.
- Enrollment is on track with over 60 activated sites and includes pediatric patients, which are critical for both commercial opportunity and regulatory modeling due to faster disease progression in younger patients.
- The primary endpoint of the safeguard study is preservation of C-peptide at 48 weeks, with HbA1c reduction as a key secondary endpoint to support full approval.
- Previous studies with similar mechanisms showed significant HbA1c reduction, and SAB Bio plans to redose patients to maintain pharmacologic activity over 48 weeks.
- The company has a long-term extension study allowing patients to continue treatment for up to two years, supporting durability and chronic dosing potential.
- The commercial opportunity for SAB 142 in the US is conservatively estimated at $4 billion, with potential to grow to single or double-digit billions due to redosing and label expansion.
- Physicians desire therapies that can make type 1 diabetes easier to manage, with SAB 142 offering a convenient dosing schedule of four days per year and a competitive safety profile based on phase one data.
- The initial commercial focus will be on academic centers and KOLs, especially for pediatric patients, with plans to address community endocrinologists through medical education and MSLs.
- The prize trial will evaluate patients up to two years from diagnosis to test the hypothesis that the current 100-day post-diagnosis cutoff is arbitrary, potentially expanding the market opportunity.
- SAB Bio’s transchromosomic cow platform produces fully human IGG antibodies, offering advantages over existing animal-derived IVIG products, including no serum sickness and the ability to redose.
- The company has strong IP protection including trade secrets and patents, with no biosimilar pathway for plasmid-derived IVIG, supporting long-term exclusivity.
- A second South Dakota facility is under construction to establish a redundant herd to mitigate risks and ensure manufacturing continuity.
- Beyond type 1 diabetes, SAB Bio plans to expand SAB 142 into other T-cell-mediated autoimmune diseases as the program matures.
- Cash balance at the end of the last quarter was $208 million, providing runway through the end of 2028 to cover safeguard data, prize trial initiation, pre-commercial activities, and manufacturing.
- An enrollment tranche related to the safeguard study is expected by late 2026 or early 2027, which is not included in the current cash runway.
- Management emphasized their mission to transform type 1 diabetes treatment from insulin dependence to organ preservation and potential insulin-free status with early intervention.
STOCKNOW INSIGHTS
Continue with outlook and guidance.
Log in to unlock executive comments and Q&A highlights.
Log in for the full summaryStockNow uses AI to translate and summarize earnings calls. Accuracy and completeness are not guaranteed.
Transcript
Preview the first fifteen paragraphs, organized by speaker.
Good morning. I am Sam Semenko. 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 to 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 to 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?
FULL TRANSCRIPT
Continue the full translated transcript in StockNow.
Log in to unlock every statement, the English original, and speaker-by-speaker history.
Log in for the full transcriptCall participants
3 people spoke on this call — only 1 are shown here.
PARTICIPANT LIST
View participant details in StockNow.
Log in to see executives and analysts, their roles, and complete speaking history.
Log in to view all participantsKeep exploring