Mr. Jonathan Rigby reports

SERNOVA BIOTHERAPEUTICS PROVIDES UPDATE ON PHASE 1/2 CLINICAL TRIAL OF CELL POUCH™ BIO-HYBRID ORGAN FOR TREATMENT OF TYPE 1 DIABETES

Sernova Biotherapeutics Inc. today provided an update on its continuing clinical trial in patients with T1D.

Yesterday, on March 31, the Data and Safety Management Board (DSMB) for Sernova's phase 1/2 clinical trial conducted a scheduled annual data review. The DSMB has sanctioned the enrolment of the final patient in Cohort B. In addition, following consultation with the DSMB, Sernova is preparing to advance to Cohort C of the trial in H2 2025.

The primary end point of the company's continuing phase 1/2 clinical trial is the demonstration of safety and tolerability of islet transplantation into Cell Pouch for the treatment of T1D in patients with hypoglycemia unawareness and a history of severe hypoglycemic episodes. Based on the clinical data that Sernova has acquired to date, and the endorsement of safety from the DSMB, the company believes it is on track to achieve this end point.

Upon conclusion of Cohort C, Sernova plans to launch a T1D clinical trial of the Cell Pouch biohybrid organ with induced pluripotent stem cell (iPSC) islet-like clusters in collaboration with Evotec.

The company believes that Sernova's Cell Pouch biohybrid organ, that is prevascularized prior to islet transplantation, is the only implantable and retrievable cell containment system for islet engraftment and function currently in United States clinical trials. Data from the continuing trial has demonstrated islet cell survival in T1D patients from one year to more than five years as well as the ability to support insulin independence following protocol specified treatment. In addition, there has been no evidence of detrimental fibrosis of the Cell Pouch on histological analysis.

"We have collected a significant amount of data in our ongoing clinical trial and results to date suggest that we are tracking towards meeting our key clinical end points," said Jonathan Rigby, president and chief executive officer of Sernova Biotherapeutics. "We have made a great deal of strategic, operational and financing progress over recent months, and, as a Type 1 diabetic myself, I am truly excited about the potential of our T1D Cell Pouch biohybrid organ and look forward to advancing our clinical trial to a positive conclusion."

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 a biohybrid organ to treat T1D. A biohybrid organ comprises non-biomaterials, such as the Cell Pouch, integrated with living tissues to replace the function of a compromised organ. This innovative approach aims to deliver a potentially revolutionary treatment for patients with chronic diseases, initially focusing on T1D and thyroid disorders.

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