Mr. Jonathan Rigby reports

SERNOVA BIOTHERAPEUTICS PROVIDES POSITIVE INTERIM DATA FROM ONGOING PHASE 1/2 CLINICAL TRIAL OF CELL POUCH BIO-HYBRID ORGAN IN PATIENTS LIVING WITH TYPE 1 DIABETES

Sernova Biotherapeutics Inc. has released positive interim data from its continuing phase 1/2 clinical trial in patients with Type 1 diabetes (T1D).

Interim data from 12 patients with transplanted human donor islet cells in Cohort A and continuing Cohort B show patients achieving insulin independence, islet cell engraftment in Cell Pouch, islet function, islet survival, improved glycemic control, improved patient-reported quality of life (QOL), improved awareness of hypoglycemia and increased sensitivity to severe hypoglycemic symptoms. Improvement in patient outcomes was correlated with a cumulative increase in the quantity of transplanted islets. Based on these findings, the study is on track to meet its primary and secondary end points, and the confirmatory Cohort C is expected to initiate in the second half of 2025.

Clinical trials with iPSC islet-like clusters from Sernova's partner, Evotec, are anticipated to begin in 2026 after completion of Cohort C of the continuing trial. These interim findings, with eight of 12 patients achieving insulin independence so far, support the thesis that Sernova's high-volume, 10-channel Cell Pouch, used in Cohort B, plus an optimized immune suppression regimen, has the potential to achieve insulin independence, without portal vein transplant, in the company's planned clinical trial with Evotec's high-quality iPSC islet-like clusters.

C-peptide is a biomarker that measures the amount of insulin produced by the transplanted islets. For successful islet transplantation, a C-peptide level of 0.3 nanogram per millilitre (0.1 nanomole per litre) is generally considered a threshold for graft function. Seven of 12 patients showed C-peptide levels of 0.3 nanogram per millilitre or greater, indicating successful islet cell engraftment and insulin production by islets transplanted to the Cell Pouch alone. The interim data, as analyzed using industry-standard composite beta and beta-2 scores, as well as histology of explanted Cell Pouches provide further evidence of engraftment and function of islet cells after transplantation into the Cell Pouch alone.

Measured HbA1c (a blood test that shows the average blood sugar levels over the past two to three months) in patients with Cell Pouch alone, showed that nine of 12 patients had a reduced value within the American Diabetes Association (ADA) recommended range of less than 7.0 per cent. Of the remaining three patients, one experienced a 24-per-cent reduction in HbA1c from 10.3 per cent to 7.8 per cent and the other two maintained a normal HbA1c value of less than 7 per cent as measured at baseline. Published clinical studies found that each 1-per-cent reduction in A1c was associated with a 14-per-cent reduced risk of myocardial infarction. A single portal vein transplant resulted in all patients having a recommended HbA1c of less than 7.0 per cent, which was maintained for the duration of the study.

"I have been living with Type 1 diabetes almost my entire life. This interim data showing successful functionality of our Cell Pouch biohybrid organ and improvement in patient-reported quality of life inspires me and my Sernova colleagues to forge ahead to prevent the long-term co-morbidities associated with T1D," said Jonathan Rigby, chief executive officer of Sernova. "The experience of hypoglycemia haunts people with T1D 24 hours a day -- it is terrifying; it is debilitating. We won't stop until we complete the development of a functional cure."

Patients self-reported data on one industry-standard survey that assesses hypoglycemia awareness and two industry-standard quality-of-life surveys.

The Clarke Hypoglycemia Awareness Scale was used to assess study participants' awareness of hypoglycemia, or low blood sugar, and data show that 11 of 12 patients reported improved awareness of hypoglycemia and increased sensitivity to severe hypoglycemic symptoms. The improved ability to recognize the warning signs of a low-blood-sugar episode is crucial for managing diabetes and preventing severe hypoglycemic episodes.

The Hypoglycemia Fear Survey-II (HFS-II) is a validated measure of fear of hypoglycemia in people living with diabetes. Lower scores reflect a decrease in worry and avoidance behaviours related to hypoglycemia, which have positive implications for diabetes management, including better adherence to treatment plans, improved glucose control and a reduction in avoidance behaviours that can negatively impact blood sugar levels. Ten of 12 patients reported a reduction in HFS-II scale, indicating a reduction in fear of hypoglycemia.

The Diabetes Distress Score (DDS), a validated questionnaire designed to assess the emotional burden and distress associated with managing diabetes, was used to identify specific areas of concern. This includes emotional burden and regimen-related challenges to understand the psychological impact of living with T1D and any changes from baseline. Reduced diabetes distress can be associated with improved glycemic control, better self-care practices and enhanced overall quality of life. Ten of 12 patients had a lowering of their DDS, indicating a reduction in distress associated with managing their T1D.

Dr. Robert Gabbay, former chief medical officer of the American Diabetes Association and an adviser to Sernova, said: "These data are positive and indicate that a threshold cumulative quantity of implanted islets can be reached to show clinical effect. I look forward to Sernova entering the clinic with Evotec's abundant supply of iPSC islet-like clusters, which are consistently high quality compared to human donor islets. I have spent my career caring for persons living with T1D and believe that the Cell Pouch biohybrid organ has the potential to be a functional cure for T1D."

About Sernova Biotherapeutics Inc.

Sernova Biotherapeutics is a clinical-stage company developing regenerative medicine therapeutics combining its Cell Pouch with human donor cells or stem-cell-derived islet-like clusters in collaboration with Evotec to create biohybrid organs to treat T1D. A biohybrid organ comprises non-biomaterials, such as the Cell Pouch, integrated with living tissues to restore or enhance the function of a compromised organ. This innovative approach aims to deliver a potentially revolutionary treatment for patients with chronic diseases, initially focusing on T1D and thyroid disorders.

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