SAB Biotherapeutics, Inc. (SABS) Q3 2026 Earnings Report, Transcript and Summary

Good morning, and welcome to SAB BIO's conference call to discuss third quarter 2026 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. 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. [Operator Instructions] 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.

Thank you, operator. Good morning, and thank you to everyone joining us for our third quarter 2026 earnings call. I'm joined today by Lucy To, our Chief Financial Officer, who will review the third quarter financial results. I'm also joined by Eddie Sullivan, our Co-Founder and President, and Alexandra Kropotova, our Chief Medical Officer. As we begin November, we recognize Diabetes Awareness Month and focus attention on the millions of people living with type 1 diabetes. We remain committed to advancing new medicines with the potential to change the course of the disease and improve the lives of those affected. That focus continues to drive our work at SAB BIO, and we're pleased to have you with us today to review the progress we made during the third quarter. We continue to execute on our priorities for SAB-142 with strong momentum in SAFEGUARD enrollment and the FDA granting Fast Track designation to SAB-142 for the treatment of new-onset Stage 3 type 1 diabetes. For context, SAB-142 is a fully human anti-thymocyte immunoglobulin designed to preserve insulin-producing beta cells in order to slow disease progression in autoimmune type 1 diabetes. It was developed using our proprietary Tc Bovine platform, which allows us to generate fully human, multi-specific antibodies without the need for human donors. Because SAB-142 is fully human, it has the potential to overcome key limitations of non-human approaches and enable safe redosing over the long term. We believe SAB-142 represents an opportunity to help people with type 1 diabetes redefine what a Stage 3 diagnosis can mean. SAB-142 is currently being evaluated in 2 clinical trials, the registrational Phase 2b SAFEGUARD study for those newly diagnosed with Stage 3 T1D and the investigator-led Phase 3 PRISE study for people up to 2 years from a Stage 3 T1D diagnosis. Let's start with an enrollment update for SAFEGUARD. The performance of our clinical team this quarter has been exemplary. In September, the study's Data Monitoring Committee approved the final step-down to children ages 5 to 11, helping to further accelerate enrollment. We continue to see strong interest in SAFEGUARD from both patients and investigators, and we're excited to share that the adult and adolescent cohorts are now fully enrolled and closed for screening. With that, we are reaffirming our guidance to complete enrollment of SAFEGUARD in Q4, with topline data expected in the second half of '27. Building on that progress, the PRISE study expects to dose the first patients this quarter. There are 7 clinical sites planned across the United States, Europe and the UK. PRISE is an important extension of the SAB-142 clinical program as it would potentially allow a future label expansion for SAB-142 to T1D patients up to 2 years from a Stage 3 diagnosis. As a reminder, PRISE is an investigator-led study supported by a grant from Breakthrough T1D and co-funded by SAB BIO. We are grateful to Breakthrough T1D for its support and to Dr. Michael Haller at the University of Florida, who serves as the study's principal investigator. We also want to recognize Dr. Chantal Mathieu at UZ Leuven and Dr. Timothy Tree at King's College London as co-principal investigators for their important contribution to the study. Beyond our clinical progress, we reached an important regulatory milestone in October when the FDA granted Fast Track designation to SAB-142 for the treatment of new-onset Stage 3 type 1 diabetes. This designation is intended to facilitate the development and expedite the review of therapies for serious conditions where there is an unmet medical need, with the goal of bringing important new treatments to patients earlier. For SAB-142, this designation gives the program some serious aura. And importantly, it provides valuable procedural benefits as we advance our program. These include opportunities for more frequent meetings and written communications with the FDA, eligibility for rolling review of the future BLA and potential eligibility for Priority Review if the applicable criteria are met. While Fast Track designation does not change the FDA's standards for approval or ensure that SAB-142 will ultimately be approved, we believe the benefits are meaningful as we move toward topline data. We will continue to work closely with the FDA as we advance the SAB-142 clinical program. And we believe this designation represents meaningful progress toward our goal of bringing SAB-142 to people living with type 1 diabetes as quickly as possible. And with that, I will hand the call over to Lucy To, our Chief Financial Officer, for a recap of our third quarter financials.

Thanks, Sam. We ended the third quarter with $205 million in cash, cash equivalents and investment securities as of September 30, 2026. We maintain a strong cash position and project that our existing cash balance will fund our operations through 2028. This total includes $13.4 million in gross proceeds received in the third quarter from the exercise of our previously issued enrollment and data release warrants from our July 2025 PIPE. R&D expenses were $18.1 million for the third quarter of 2026 compared to $9 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. R&D expenses include non-cash stock-based compensation expense of $3.9 million for the third quarter of 2026 compared to $0.5 million for the same period in 2025. G&A expenses were $7.8 million for the third quarter of 2026 compared to $3.7 million for the same period in 2025. The increase is primarily driven by personnel-related costs, including non-cash stock-based compensation. G&A expenses include non-cash stock-based compensation expense of $3.6 million for the third quarter of 2026 compared to $0.3 million for the same period in 2025. Other income was $3.6 million for the third quarter of 2026 compared to $58.1 million for the same period in 2025. The decrease primarily reflects the change in fair value of warrant liabilities recognized in 2025. As a result, net loss was $22.3 million for the third quarter of 2026 compared to the net income of $45.4 million for the same period in 2025. Overall, we reaffirm our position to support SAB-142's clinical development in the SAFEGUARD and PRISE studies through key milestones while preparing for commercial readiness for SAB-142. And with that, I can turn it back over to Sam for closing remarks before we open the call for questions.

Thanks, Lucy. We're pleased with the progress we made during the third quarter and enter the final months of the year with a clear focus: completing enrollment in SAFEGUARD and continuing to advance SAB-142 toward topline data. We are incredibly grateful to our team, our investigators and clinical collaborators, the patients and families participating in SAFEGUARD and the broader diabetes community. Their commitment and engagement continue to drive our work and reinforce the importance of developing new therapies for people living with type 1 diabetes. As we look to 2027, we're excited to move toward topline data from SAFEGUARD while continuing to build the capabilities and infrastructure needed to support SAB-142 over the long term. We believe SAB-142 has the potential to meaningfully change the treatment of type 1 diabetes and we are focused on delivering on that promise. We look forward to sharing our progress as we continue advancing SAB-142 across our clinical programs and executing on our strategy. And with that, we're ready to take any questions.

[Operator Instructions] The first question is from Michael Yee from UBS.

Congrats on the progress on enrollment. As we think about the data ahead next year, could you sort of comment or reiterate your framing of expectations on that result in terms of C-peptide and A1C, and how important each of those are to hit for differentiation to Tzield? And secondly, given that Tzield now has a new Stage 3 indication, while we've been talking with different docs, what are you hearing out there? What are you seeing? And is that perhaps a pretty good indication of what the opportunity could be, although it's still early there?

Thanks, Mike. I'll answer the second part first and then hand it to Alexandra to answer the first question. So the second part on Tzield, we're very encouraged by what we're seeing with Tzield. The uptake in the community shows the importance of new medicines, and it's paving the way and establishing a pattern with doctors and patients to get treatment, to get a prescription to preserve the pancreas when a patient is diagnosed. So we're encouraged by what we're seeing and I think it bodes well for SAB-142 as it's -- as we believe strongly that it's a competitive product with fewer days of dosing. We'll see where the results are on the efficacy, but also will overall have a better profile. So I think everything we're seeing with Tzield is good news for the field and for SAB-142. And for the first part, I'll hand it over to our Chief Medical Officer, Alexandra, to answer the question.

Thank you very much, Sam. We are very hopeful about our upcoming data release next year. Of course, the primary endpoint of the preservation of the beta cell function as measured by the area under the curve C-peptide is our primary endpoint, and we'll be reporting the results on that, where the statistically significant results versus control arm will guarantee us the accelerated path to the approval for the product. Now ATG is a clinically validated mechanism of action where previous multiple clinical trials showed the important improvement in the glycemic control needed for the full approval of the medications in the disease-modifying therapies, and we will be releasing the data on the glycemic control as well based on the HbA1c and the continuous glucose monitoring. Now third component of a very important differentiation profile of the SAB-142 versus Tzield is the low immunogenicity due to the full human nature of the antibody that will allow the drug to provide the disease-modifying therapy over a lifetime of the disease of the patients, where the product can be redosed to continue maintaining the C-peptide and preserving the residual beta cells, not only over 1 or 2 courses but for over a much longer period. So immunogenicity data and the safety data associated with the long-term redosing will be part of our topline as well.

The next question is from Ellie Merle from Barclays.

This is Tejas on for Ellie. My first one, just for the study in the patients 2 years from diagnosis, could you expand on just some of the different cohorts of patients across that 2-year timeframe and what you're looking to see in each of those? And then I have a follow-up.

Sure. So it's a sister study to the SAFEGUARD study. The protocol is exactly the same with one exception, which is the time from diagnosis. One cohort is age-matched from the SAFEGUARD population that's effectively the control, and that's patients within 100 days of diagnosis. One cohort is from 100 days to 365 days, which is that window out to a year. And what we call Cohort 3, or the third cohort, is from 1 year to 2 years. And the importance of that and that data is to prove that the thing that matters most with a patient is the amount of beta cells they have and our ability to preserve those. And the T1D community and SAB want as many patients as possible to be able to get access to SAB-142. And the PRISE study is designed to show that we can provide a benefit to patients up to 2 years from diagnosis.

Great. And then just a quick follow-up on timing. When could we expect to get data from any of these cohorts, and how could that be used to support a label expansion or inform a registrational trial in those various populations?

Well, so on the timing, I don't know that we're guiding to a specific time yet as it's an investigator-led study. I think we would expect it to be subsequent to SAFEGUARD data, but we'll see and we'll keep you posted on that. As far as the label, pending good outcome we would hope to and have the potential to have time not be a basis for diagnosis and just beta cells. So if a patient with type 1 diabetes has adequate beta cells for preservation, there's a possibility that that might be all that's required for being able to get treated and covered. And maybe if you step it back to just one step more conservative, perhaps it's up to 2 years from diagnosis, which will markedly expand the available total addressable market as well as have the ability to increase market penetration by not having this kind of a gun to the head of a patient with, you have to get it now or you're not going to be able to get it.

The next question is from Roger Song from Jefferies.

This is Cha Cha on for Roger. I was hoping that you could give us more color in regards to the September DMC approval. Can you share more on what safety parameters were particularly important in supporting the expansion to the pediatric population?

Sure. I'll let Alexandra answer that.

Thanks, Sam. So we have the independent Data Monitoring Committee that has been a part of the SAB-142 development program for over the last 2 years. The DMC consists of the 1 adult endocrinologist and 2 pediatric endocrinologists along with the independent biostatistician. For pre-scheduled, predefined DMC meetings, cumulative data for the SAB-142, which means that all data that were accumulated from the beginning, the very first patient enrolled in a trial, all the way until the DMC scheduled meeting were provided, the data were provided to the DMC in an unblinded fashion. It means that the DMC committee saw the data by treatment arm versus control. And it's all available safety data across populations, broken also down by the age groups, adult versus adolescent and versus pediatric population. We had the DMC meetings that approved the step-down as planned without any delays, indicating that the product behaves very consistently and there is no new safety signal identified in the ongoing SAFEGUARD trial. So we're very, very pleased with how the product behaves. And it's again a very, very consistent safety profile across all age groups.

The next question is from Yatin Suneja from Guggenheim Securities.

This is Iris Gao on for Yatin. Congratulations on the progress with both studies. So my first question would be like, is there an update on how many patients have been redosed so far, and is the drug still clean on ADAs? And my second question would be about like, how does the PRISE study affect the burn rate going forward?

We haven't disclosed to date how many patients have been redosed, but it's going according to plan. And then the second part was -- I'm sorry, could you repeat it? I didn't hear it.

Oh, yes. It's how do you expect the PRISE study to affect the burn rate going forward?

We had included that study in our budgeting process. So the burn as guided has accounted for the PRISE expenses and doesn't change.

The next question is from Thomas Smith from Leerink Partners.

This is Brian on for Tom. Congrats on all the progress. So first, given adult and adolescent cohorts here are fully enrolled in SAFEGUARD, can you comment on if there's anything notable on the baseline characteristics of the patients in these cohorts relative to your expectations? And then we have a quick follow-up.

I'll let Alexandra answer that.

Our baseline characteristics for both cohorts are comparable to the baseline characteristics of the respective age cohorts in previous trials, TN-19 and MELD-ATG. So the data is very consistent, again, even at the baseline.

Got it. And our second question, just on the PRISE trial understanding that in SAFEGUARD we needed to have that step-down from adults to pediatric patients, can we expect a similar dynamic in PRISE given at least some of the overlap in patient population? Or can you begin enrolling those pediatric patients once the study begins recruitment given the safety data you've generated to date?

Yes, excellent question. And yes, we are starting enrollment in the PRISE-hATG study with the early age cohorts considering that we already have a very significant amount of the safety data accumulated through SAFEGUARD, and the DMC, independent DMC committee across the program. So it's the same DMC who already has seen all the data from the SAB-142 in previous trials who will be guiding and monitoring the safety in PRISE.

The next question is from Samantha Semenkow from Citi.

This is Ben on for Sam. Can you describe the level of physician interest in the PRISE study? What kind of feedback are you receiving based on the site interactions? And then I have a separate question, if I may.

Yes, physician interest is very high. I think that we mentioned that Dr. Haller at University of Florida, Dr. Mathieu in Belgium and Dr. Tim Tree at King's College proposed this study design because of the tremendous interest. If you can imagine that both all the clinical research done with immunomodulation as well as now the first approved therapy, Tzield, limits a patient's ability to get dosed to the first up to 8 weeks, SAFEGUARD has been the most inclusive, up to 100 days so far. There's a huge pent-up demand and frustration both at the physician level and the patient level of people who are being excluded from the ability to get therapy or participate in clinical research. So interest is high, demand is high, and it really is inbound interest from the T1D community and the academic community to SAB that we're gladly collaborating with and accommodating.

And then turning back to SAFEGUARD, what is the pace of the pediatric screening and enrollment? Is it tracking with your expectations?

Yes, it's good. We're pleased by how it's going. And we're reiterating that we expect to complete enrollment this quarter.

The next question is from Keay Nakae from Chardan.

With respect to PRISE Cohort C patients, how do you -- it's not clear to me from the inclusion/exclusion, how do you best handicap which patients at that duration of onset might be best suited to show a positive result?

I think it's all about C-peptide at baseline. It's the same study design as SAFEGUARD. The only difference is that time from diagnosis. So the amount of C-peptide which meeting the inclusion criteria for baseline C-peptide is that. And Alexandra, do you have anything to add?

And then the additional parameter is the age groups. Similar to SAFEGUARD, we have predefined parameters for the sample size across the adult, adolescent and pediatric population in approximately similar 1/3 of each population fashion, since the disease progression may be dependent on the age as well. So baseline C-peptide and age are 2 parameters that participate in the stratification randomization at the baseline of the PRISE-hATG participants.

The next question is from Seema Sheoran from Rodman Financial.

Congrats on the progress. So in April you presented impressive 4-patient data where 3 patients were described as super-responders, showing C-peptide levels above baseline at 120 days, or 4 months. My understanding is that this cohort is not receiving additional doses whereas SAFEGUARD includes redosing. I'm just curious to know how C-peptide levels have evolved with longer follow-up in these 4 patients and what that suggests about the durability of response without redosing.

So the data we presented from the Phase 1 study was the complete dataset. The study was 120 days long. That was the last study visit. And so we have not collected data beyond that.

This concludes the question-and-answer session as well as today's teleconference. You may disconnect your lines at this time. Thank you for your participation.