SVA Sernova Biotherapeutics Inc

Sernova Biotherapeutics, (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a leading regenerative medicine company focused on developing its Cell Pouch bio-hybrid organ as a functional cure for type 1 diabetes, today announced the submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) 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 bio-hybrid 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 post-operative 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, CEO 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 re-implantation of thyroid tissue into the pre-vascularized Cell Pouch, without immune suppression, resulted in the restoration of the two main thyroid hormones, thyroxine (T4) and triiodothyronine (T3), to pre-thyroidectomy 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 re-implantation. 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 bio-hybrid organ with autologous thyroid cells in patients undergoing thyroidectomy for benign nodular disease.

ABOUT SERNOVA BIOTHERAPEUTICS

Sernova Biotherapeutics 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 bio-hybrid organs to treat chronic diseases. A bio-hybrid organ is comprised 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.

FOR FURTHER INFORMATION, PLEASE CONTACT:

David Burke VP, Investor Relations (917) 751-5713 Email: David.Burke@sernova.com Website: https://sernova.com/

The TSX has not reviewed this news release and does not accept responsibility for the accuracy or adequacy of this news release.

FORWARD-LOOKING INFORMATION

This press release contains forward-looking statements within the meaning of applicable Canadian securities laws. Forward-looking statements in this press release include our plan to consider the initiation of a clinical trial in patients undergoing thyroidectomy for benign nodular thyroid disease. With respect to the forward-looking statements contained in this press release, Sernova has made numerous assumptions regarding, among other things: the company’s ability to secure additional financing on reasonable terms, or at all; and the ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch, including the timing and results of those trials. A more complete discussion of the risks and uncertainties facing Sernova appears in Sernova’s Annual Information Form for the year ended October 31, 2024 filed with Canadian securities authorities and available at www.sedarplus.ca, as updated by Sernova’s continuous disclosure filings, which are available at www.sedarplus.ca. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Sernova disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.