SABS

• T-field is only approved in the U.S. for stage 3 disease, with an approved label limited to patients 8 to 17 within 8 weeks of diagnosis
• The company's Safeguard trial evaluates patients ages 5 to 40 within 100 days of diagnosis, and some U.S. patients elect to enroll in Safeguard even after T-field becomes available due to SAB 142's competitive dosing profile
• T-Zield (TZL) U.S. approval for stage 3 disease is considered positive for patients, the broader clinical field, and the company's SAB program: it drives disease and treatment awareness/education, and confirms C-peptide as a valid endpoint for accelerated approval
• The company has sufficient drug supply to support both of its ongoing clinical trials

• Step-down enrollment for pediatric patients age 5 and above in the Safeguard trial is anticipated this quarter
• Full enrollment of the Safeguard trial remains on track to be completed in Q4 of the current year
• Top line data from the fully enrolled Safeguard trial is expected in the second half of 2027, with guidance unchanged from prior updates
• Top line results for the PRIZE (Prize AQG) registrational study are expected in Q1 of 2029

No financial performance or product segment revenue data was provided in the transcript.

No explicit discussion of operational risks, business risks, or operational failures was included in the provided transcript.

Q: What is the current status and timing for expanding the Safeguard trial to pediatric patients age five and above, and when can top line data be expected after full enrollment? / A: Expansion to eligible pediatric patients is expected to happen this quarter, with full Safeguard enrollment on track to complete in Q4 of this year. Top line data is still projected to be delivered in the second half of 2027, with no changes to prior guidance.

Q: How many sites are planned for the PRIZE study, could its enrollment pace match Safeguard's, and what launch metrics for approved T-Zield does the company track to size the SAB 142 opportunity? / A: The PRIZE study will include 7 total sites: 4 in the U.S. and 3 in Europe. It was launched on a staggered timeline relative to Safeguard, with results expected in Q1 2029. It is too early to draw conclusions from the early T-Zield launch; recent T-Zield disclosures reflect prior pediatric/EU expansions rather than the new mid-June stage 3 approval.

Q: How is the PRIZE AQG study powered for its clinical endpoints? / A: PRIZE AQG is a registrational trial, so it is adequately powered to detect differences between the active treatment and placebo arms for its 12-month C-peptide primary endpoint (measured via two-hour MMCT). It is also powered for its key secondary glycemic control endpoint following the same structure used in the prior SAVE-GRA trial.

Q: How can PRIZE enroll efficiently with only 7 planned sites even for a larger target patient population, and what is the screening failure rate for the Safeguard trial? / A: PRIZE is the only ongoing trial that allows enrollment of patients up to 730 days after disease onset, a population with no other available trial options, so strong patient demand drives efficient enrollment even with a small site count. The company does not disclose detailed operational metrics like Safeguard screening failure rates, and confirms enrollment remains on track for Q4 completion.