Dr. Philip Toleikis reports

SERNOVA ANNOUNCES POSITIVE UPDATED INTERIM PHASE 1/2 CLINICAL DATA FOR THE CELL POUCH SYSTEM(TM) AT AMERICAN DIABETES ASSOCIATION 83RD SCIENTIFIC SESSIONS

Sernova Corp. has released updated positive interim data from its continuing 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, MD, PhD, at the University of Chicago, were presented during an oral podium presentation at the American Diabetes Association (ADA) 83rd Scientific Sessions, on June 24, 2023, in San Diego, Calif.

The presentation discussed the first 11 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 four years following implant. During the trial, the function of the transplanted islets is measured by blood glucose levels, patient insulin usage and serum C-peptide -- a measure of islet insulin secretion.

To date, five patients in the first cohort of six 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 six months to greater than three 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-per-cent-greater transplant capacity than the previous eight-channel system. Five of seven patients meeting the trial eligibility criteria have been enrolled in the second cohort and implanted with the higher-capacity Cell Pouch. Three of the five 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 prevascularized 10-channel Cell Pouch.

Key points from the interim clinical update:

• Long-term surgical implantation of the Cell Pouch continues to be well tolerated with a favourable safety profile in patients receiving either eight-channel or 10-channel Cell Pouches.
• Five of six patients in the first cohort achieved insulin independence following supplemental islet transplants through the portal vein that were below the typical intraportal islet dose, indicating that islet graft function in the eight-channel Cell Pouch is supporting continuing glucose control.
• Histological assessment of sentinel Cell Pouches excised at greater than or equal to 90 days posttransplant revealed surviving functional islets in five of six patients in the first cohort.
• The five patients in the first cohort that have achieved insulin independence have each remained free of endogenous insulin therapy ranging from six months to greater than three 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, five of seven planned patients are now enrolled and implanted with the higher-capacity Cell Pouches. Three of the five 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 are expected in the second half of 2023.

"We are very pleased to see these positive data for our T1D trial with Cell Pouch, and especially our 10-channel Cell Pouch configuration, as we pursue a functional cure for patients with T1D," said Dr. Philip Toleikis, president and chief executive officer of Sernova. "These additional data continue to confirm our understanding and provide verification of our estimates of islet dose thresholds and density required for optimal efficacy in this patient population. We continue to follow through on our commitment to rapidly enroll the study's second cohort, while setting the stage for Cell Pouch in combination with Evotec's iPSC-derived islet-like clusters in our upcoming clinical trial."

Dr. Witkowski, director of the pancreatic and islet transplant program at the University of Chicago, and principal investigator of the clinical trial, added: "I continue to be encouraged by the results achieved in this trial, and especially by the ease of use and favourable response from a single islet transplant to the larger Cell Pouch. I look forward to reporting further data later this year."

To add to the continuing phase 1/2 clinical trial of the Cell Pouch system in T1D, Sernova also continues to advance its global strategic partnership with Evotec SE. Together the companies remain on track to advance Sernova's Cell Pouch in combination with Evotec's iPSC-derived (induced pluripotent stem cell) islet-like clusters into the clinic. Furthermore, Sernova is advancing its conformal coating cellular immune protection technologies in collaboration with the University of Miami with the goal to reduce or eliminate the need for immunosuppression agents.

About Sernova Corp.

Sernova is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease and blood disorders that include hemophilia A. Sernova is currently focused on developing a functional cure for insulin-dependent diabetes with its lead asset, the Cell Pouch system, a novel implantable and scalable medical device with immune-protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova's Cell Pouch system has demonstrated its potential to be a functional cure for people with T1D in a continuing phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May, 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC-based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (Type 1 and Type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch system: a novel therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral factor VIII gene therapy for hemophilia A.

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