Mr. Jonathan Rigby reports

SERNOVA BIOTHERAPEUTICS SUBMITS IND APPLICATION FOR ITS CELL POUCH BIO-HYBRID ORGAN WITH AUTOGRAFT THYROID CELLS IN PATIENTS WITH HYPOTHYROIDISM

Sernova Corp. has submitted an investigational new drug application with the U.S. Food and Drug Administration to evaluate the company's cell pouch auto-transplanted with thyroid cells in patients undergoing total thyroidectomy for nodular thyroid disease.

Hypothyroidism, a condition characterized by insufficient production of thyroid hormones, affects millions of people worldwide, often requiring lifelong daily hormone replacement therapy. Sernova's cell pouch biohybrid organ, in combination with autologous thyroid cell therapy, aims to restore natural thyroid function by providing a long-term, stable and physiological solution for patients suffering from postoperative hypothyroidism, without the need for immune suppression therapy.

"This IND submission represents a step forward in our commitment to transforming endocrine disorder treatment," said Jonathan Rigby, chief executive officer of Sernova. "Our cell pouch has shown the ability to establish a vascularized, organ-like environment for transplanted cells, and we believe this innovative approach could restore thyroid function and enhance the quality of life for patients facing lifelong hypothyroidism."

Data from preclinical trials demonstrated that reimplantation of thyroid tissue into the prevascularized cell pouch, without immune suppression, resulted in the restoration of the two main thyroid hormones, thyroxine (T4) and triiodothyronine (T3), to prethyroidectomy levels, without any hormone supplementation. In addition, radio-isotope uptake imaging and histology assessments confirmed the presence of healthy and functional thyroid tissues within the cell pouch five months following reimplantation. Pending FDA clearance, Sernova will explore the initiation of a first-in-human clinical trial to evaluate the safety, tolerability and efficacy of the cell pouch biohybrid organ with autologous thyroid cells in patients undergoing thyroidectomy for benign nodular disease.

About Sernova Corp.

Sernova is a clinical-stage company developing regenerative medicine therapeutics combining its cell pouch with human donor cells or stem-cell-derived cell therapies to create biohybrid organs to treat chronic diseases. A biohybrid organ is composed of 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 Type 1 diabetes and thyroid disorders.

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