Mr. Jonathan Rigby reports

SERNOVA ANNOUNCES NEW POSITIVE DATA FROM PHASE I/II TRIAL REGARDING ISLET SURVIVAL AND FUNCTION

Sernova Corp. has presented new positive interim data from the continuing phase I/II clinical trial evaluating the safety, tolerability and efficacy of the Sernova Cell Pouch transplant system containing donor islets in people living with Type 1 diabetes (T1D).

The data were presented by Dr. Piotr Witkowski, MD, PhD, professor of surgery and director of the pancreatic and islet transplant program at University of Chicago Medicine, who is the lead investigator for the study, during an oral session at the 2024 European Association for the Study of Diabetes (EASD) annual meeting in Madrid, Spain.

All six of the patients enrolled in cohort A of Sernova's phase I/II clinical trial with Cell Pouch and donor islets achieved sustained insulin independence after combined islet transplantation into Cell Pouch and intraportally. The first patient to be treated in the trial experienced sustained insulin independence for more than four years accompanied by blood sugar levels in the non-diabetic range (HbA1c less than or equal to 6.5 per cent). More than five years after the first islet transplant, the patient's Cell Pouches containing the transplanted islets were removed because immune suppression had to be stopped when that patient developed other, non-diabetic health issues not related to Cell Pouch or transplanted islets.

The new histological data from those explanted Cell Pouches confirmed abundant, well-vascularized, functioning islets consisting of cells producing insulin, glucagon and somatostatin, throughout all chambers, more than five years after being transplanted to Cell Pouch. Additionally, after being in the body for more than five years, a pathology examination confirmed there was no evidence of detrimental fibrotic tissue, material degradation or changes in the architecture of the Sernova Cell Pouch.

"I am excited to see this evidence of well-vascularized and healthy islets five years after transplant to Sernova's Cell Pouch; these interim findings are very promising," commented Dr. Witkowski. "This is a major step forward in the development of a contained and retrievable cell therapy for the treatment of T1D. This is the first evidence that I am aware of that demonstrates this level of healthy islet survival and function in an implantable and retrievable system for such a long duration."

"We believe this first-in-world data is significant for Sernova and, more specifically, provides tangible hope for T1D patients that we are a significant step further in our mission of providing a functional cure for this terrible disease; as a Type 1 diabetic myself, I could not be more determined to drive our program forward and ultimately onto the market," said Jonathan Rigby, president and chief executive officer of Sernova. "We look forward to completing cohort B in the near term and, based on positive data generated thus far, initiating cohort C of our ongoing trial later this year with an optimized immune suppression regimen. Lastly, we continue to work with our partner Evotec on the development of induced pluripotent stem cell (iPSC) derived islet-like clusters, which will provide a scalable cell source so that, one day, we can give patients with T1D their lives back."

About the phase I/II trial

The phase I/II trial (NCT03513939) is a U.S. prospective, single-arm, multicohort study evaluating the safety, tolerability and efficacy of Sernova's Cell Pouch in combination with transplanted human-donor islets in people living with Type 1 diabetes (T1D). The trial includes participants 18 years old to 65 years old with T1D who experience hypoglycemic unawareness and severe hypoglycemic episodes, and who are eligible for donor islet transplantation. The trial is currently divided into two cohorts. Cohort A involved six patients who received the first-generation eight-channel Cell Pouch. Cohort B is evaluating seven patients transplanted with an optimized 10-channel Cell Pouch, which has a 50-per-cent-greater islet capacity than the Cell Pouch used in cohort A. As part of the process, patients are implanted with the Cell Pouch subcutaneously. Approximately six weeks later -- allowing time to establish a stable immunosuppression therapy for the patient -- islets are transplanted into the prevascularized tissue chambers formed by the Cell Pouch. Safety and efficacy are assessed throughout the 12 months following the last islet transplant. Patients still dependent on insulin six months after the second islet transplant may qualify for a third transplant through the portal vein. Those who retain implants will be followed for at least three years. The secondary objectives of the trial include the following efficacy end points: continuous glucose monitoring, production of C-peptide, insulin use, HbA1c levels and the frequency of severe hypoglycemic episodes.

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 technology, the Cell Pouch transplant 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, allowing long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in patients with certain chronic diseases. Sernova's Cell Pouch transplant system has demonstrated its potential to be a functional cure for people with T1D in a continuing phase I/II clinical study at the University of Chicago.

Sernova partnered with Evotec 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's development pipeline that uses its Cell Pouch transplant system also includes: a cell 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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