Mr. Jonathan Rigby reports

SERNOVA BIOTHERAPEUTICS RECEIVES FDA ORPHAN DRUG DESIGNATION FOR AUTOLOGOUS ISLET TRANSPLANTATION FOR PREVENTION OF DIABETES DUE TO TOTAL PANCREATECTOMY

The U.S. Food and Drug Administration (FDA) has granted Sernova Biotherapeutics Inc. orphan drug designation for autologous islet transplantation (AIT) for the prevention of diabetes due to total pancreatectomy.

Sernova's proprietary Cell Pouch biohybrid organ is designed to support the engraftment and long-term function of transplanted therapeutic cells. Chronic pancreatitis causes debilitating pain and can lead to a total pancreatectomy, resulting in the patient developing Type 3c diabetes (T3cD), which is treated in the same way as Type 1 diabetes with the same long-term co-morbidities. Sernova is preparing to initiate a clinical trial with autologous islet transplantation that involves isolating the patient's own insulin-producing islet cells from the removed pancreas, placing them in Sernova's Cell Pouch and transplanting them back into the patient, negating the need for immune suppression. The goal is preservation of insulin production and prevention of postsurgical diabetes and its associated complex management and co-morbidities.

"Patients who require total pancreatectomy face a life-changing outcome: the immediate loss of pancreatic endocrine function and the risk of complex, insulin-dependent diabetes," said Dr. Melena Bellin, MD, co-director of the total pancreatectomy and islet autotransplant program at the University of Minnesota and a member of Sernova's clinical advisory board. "Autologous islet transplantation in Sernova's Cell Pouch has the potential to preserve a patient's own insulin-producing cells following pancreatic surgery, without the use of immune-suppressing therapies."

Subject to successful review of detailed applications, orphan drug designation is granted by the FDA to support the development of drugs and biologics, intended to treat, diagnose or prevent rare diseases or conditions affecting fewer than 200,000 people in the United States. The designation provides Sernova the potential for seven years of market exclusivity in the United States upon regulatory approval, plus other development incentives, including tax credits for qualified clinical testing and waiver of certain FDA user fees, if applicable criteria are met.

"Receiving orphan drug designation from the FDA is an important milestone for Sernova," said Jonathan Rigby, chief executive officer of Sernova. "Our primary focus remains advancing a functional cure for Type 1 diabetes. At the same time, this designation provides Sernova a potential exclusive lead position in preventing Type 3c diabetes. T3cD is a natural extension of our primary focus on T1D and we are planning to advance both of these programs in the coming months."

About T3c diabetes

Type 3c diabetes, also known as pancreatogenic diabetes, occurs when damage to the pancreas impairs its ability to produce insulin and regulate blood glucose. This form of diabetes can result from conditions such as chronic pancreatitis, cystic fibrosis, pancreatic cancer or other diseases affecting pancreatic function. Surgical removal of all or part of the pancreas, including total pancreatectomy performed to treat serious pancreatic conditions, can also result in Type 3c diabetes due to the loss of insulin-producing pancreatic tissue.

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 and blood vessels to provide oxygen and nutrients to contained cells to restore or enhance the function of a compromised or explanted organ.

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