SABS SAB Biotherapeutics, Inc.
$3.70
SAB Biotherapeutics, Inc. Q2 F2026 Earnings Call Transcript
Thursday, August 6, 2026
AI Conference Call Analysis
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Are you seeing maybe more inbound interest from investigators in your study? I know the enrollment was accelerated due to a pure number of sites, but just wondering increased interest in what you're doing. 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 T-field is only approved in the U.S. for stage 3. The majority of our sites are in Europe. T-field'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 U.S. who have, we've heard about, that have elected to enroll in Safeguard because of SAB 142's competitive dosing profile, even after T-field has become available.
Unknown
All right, great. Thanks. Thanks.
Operator
Conference Operator
Thank you. We'll move on now to Seema Chiron with Rodman and Rinshaw. Your line is open.
Seema Chiron
Analyst, Rodman & Renshaw
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? And I have a follow up.
Unknown
Sure.
Unknown
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.
Unknown
Okay.
Seema Chiron
Analyst, Rodman & Renshaw
Yeah, yeah. So considering that the Part B 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 top line data in second half, which I'm assuming is going to be fourth quarter?
Unknown
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.
Seema Chiron
Analyst, Rodman & Renshaw
Okay, that's helpful. One more question. How is the price HADG study powered? That's my last question. Thank you.
Unknown
I'll let Alexandra answer that.
Alexandra
Prize AQG study is the registrational trial and 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 two-hour MMCT. It's also powered for the key secondary point on the glycemic control in the similar manner as the SAVE-GRA trial.
Seema Chiron
Analyst, Rodman & Renshaw
I see. So it's like 80% powered for Thank you.
Operator
Conference Operator
We'll move on next to Emily Bodner with HC Wainwright. Your line is open.
Emily Bodner
Analyst, HC Wainwright
Hi, thanks for taking the questions. Have you commented on how many sites you're expecting to be included in the prize study? I'm just kind of curious on if timing for enrollment cadence could be similar to Safeguard. And then secondly, with the T-Zield approval now in stage three, are there any aspects of the T-Zield launch that you're tracking to kind of help frame the SAB 142 opportunity? Thank you.
Unknown
I agree with the first question, the first part, and I'll take it.
Alexandra
So the prize APG study has seven sites. Four of them are in the U.S. and other sites are in Europe. The study starts staggered versus safeguard, and the toll plan results for the price are expected in Q1 of 2029.
Unknown
And 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 in EU approval in Stage 2, rather than Stage 3, which was just approved mid-June. More importantly, TZL'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.
Unknown
Thank you.
Operator
Conference Operator
We'll move next to Kumar Raka with Brookline Capital Markets. Your line is open.
Kumar Raka
Analyst, Brookline Capital Markets
Thanks for taking my questions. I just had one follow-up on the number of sites. Given that for the price study of Planning 7 sites, how do you think you'll be able to enroll so quickly if 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? Thank you.
Alexandra
Excellent question on the involvement. 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. 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. highly interested in this clinical trial, and that enables a very efficient enrollment over a smaller number of sites.
Unknown
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.
Kumar Raka
Analyst, Brookline Capital Markets
Okay. And in terms of drug supply, where do you stand with regard to that? Thank you.
Unknown
We have sufficient supply to supply both trials.
Unknown
Okay, great. Thanks so much.
Operator
Conference Operator
Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.