Sernova Corp. announced updated positive interim data from its ongoing Phase 1/2 clinical trial of the Cell Pouch System in patients with type 1 diabetes (T1D) and severe hypoglycemia unawareness. The new data from the study, which is being conducted by Piotr Witkowski, M.D., Ph.D., at The University of Chicago, were presented during an oral podium presentation at the American Diabetes Association (ADA) 83rd Scientific Sessions, on June 24th, 2023 in San Diego, California.

The presentation discussed the first eleven patients enrolled across two cohorts in the clinical trial evaluating Cell Pouch in combination with pancreatic islets and reconfirmed the safety of Cell Pouch up to more than 4 years following implant. During the trial, the function of the transplanted islets are measured by blood glucose levels, patient insulin usage, and serum C-peptide - a measure of islet insulin secretion. To date, 5 patients in the first cohort of 6 subjects who have completed Cell Pouch implantation, islet transplant to Cell Pouch, and supplemental portal vein islet infusion, continue to experience insulin independence for periods ranging from 6 months to greater than 3 years.

The sixth patient in the first cohort has only recently completed the protocol-defined islet transplants and awaits assessment of their islet graft function. In addition, updates were provided for the second cohort with the recently implemented 10-channel Cell Pouch with more than 50% greater transplant capacity than the previous 8-channel system. Five of 7 patients meeting the trial eligibility criteria have been enrolled in the second cohort and implanted with the higher capacity Cell Pouch.

Three of the 5 patients enrolled in the second cohort have each received a first islet transplant to their implanted Cell Pouches. The first evaluable patient in the second cohort has demonstrated persistent fasting and stimulated serum C-peptide levels following a single islet transplant into the pre-vascularized 10-channel Cell Pouch. Long-term surgical implantation of the Cell Pouch continues to be well tolerated with a favorable safety profile in patients receiving either 8 or 10-channel Cell Pouches.

· Five of 6 patients in the first cohort achieved insulin independence following supplemental islet transplants via the portal vein that were below the typical intraportal islet dose, indicating that islet graft function in the 8-channel Cell Pouch is supporting ongoing glucose control. · Histological assessment of sentinel Cell Pouches excised at =90 days post-transplant revealed surviving functional islets in 5 of 6 patients in the first cohort. · The 5 patients in the first cohort that have achieved insulin independence have each remained free of endogenous insulin therapy ranging from 6 months to greater than 3 years.

The sixth patient in the first cohort has recently completed the protocol-defined islet transplants and is awaiting their next islet graft assessment. · In the second cohort, 5 of 7 planned patients are now enrolled and implanted with the higher capacity Cell Pouches. Three of the 5 patients have received their first dose of pancreatic islets transplanted to Cell Pouch.

· One patient in the second cohort has demonstrated persistent serum C-peptide levels after only a single islet transplant into 10-channel Cell Pouch. The first patient in the second cohort developed persistent neutropenia requiring cessation of immunotherapy. The third patient awaits their first islet graft assessment.

Further data from the second cohort of the clinical trial is expected in the second half of 2023.