Mr. Jonathan Rigby reports

SERNOVA BIOTHERAPEUTICS ANNOUNCES COLLABORATION WITH ELEDON PHARMACEUTICALS TO ADVANCE A POTENTIAL FUNCTIONAL CURE FOR TYPE 1 DIABETES

Sernova Biotherapeutics Inc. has signed a collaborative research agreement with Eledon Pharmaceuticals Inc. (Nasdaq: ELDN) to evaluate Eledon's immunosuppressive agent tegoprubart (AT-1501) in Sernova's continuing phase 1/2 clinical trial of its cell pouch biohybrid organ in patients with Type 1 diabetes (T1D).

Under the terms of the agreement, Eledon will supply tegoprubart, an investigational anti-CD40L antibody being evaluated for its potential to prevent transplant rejection in islet cell, kidney and xeno transplantation, will be used in place of tacrolimus in the upcoming Cohort C of Sernova's phase 1/2 clinical trial. Tacrolimus is currently a standard immunosuppressive drug used in organ transplantation to prevent rejection. However, its potential toxicity, particularly toward insulin-producing beta cells and its side effect profile limit its suitability as an optimal immunosuppressive agent for islet cell therapy in T1D.

In an investigator-initiated study led by Dr. Piotr Witkowski, a leading expert in islet transplantation at the University of Chicago, T1D patients received islet transplants along with tegoprubart to prevent rejection. Three participants achieved normal, stable blood sugar levels and became insulin independent. Islet engraftment, measured by graft function standardized to the number of islets infused, was three to five times higher than in comparable subjects outside this study who received tacrolimus-based immunosuppression, suggesting treatment with tegoprubart better protects transplanted islets resulting in improved graft survival and function. Treatment was generally well tolerated in all subjects with no unexpected adverse events or severe hypoglycemic episodes.

"As a person living with Type 1 diabetes, I am very excited by the promising results demonstrated in recent clinical trials of tegoprubart. These data suggest that combining our cell pouch biohybrid organ technology with Eledon's innovative immunosuppression could enable patients to achieve insulin independence more rapidly and with significantly less toxicity to islet cells," stated Jonathan Rigby, Sernova's chief executive officer. "It's great to see that other companies are generating positive T1D data using non-retrievable stem cell islets implanted in the liver. By transitioning to Evotec's stem cell-derived islet-like clusters in our fully retrievable biohybrid organ and using tegoprubart as a key part of immunosuppression, we believe we will offer the leading product in the field and enhance our potential to deliver a functional cure for T1D."

"We are pleased to partner with Sernova as they advance their cell pouch biohybrid organ in clinical trials," said David-Alexandre C. Gros, MD, chief executive officer of Eledon. "Our anti-CD40L antibody, tegoprubart, has demonstrated strong potential to protect transplanted cells without the toxicities of standard immunosuppression, and we believe combining it with Sernova's technology and cells could transform the treatment landscape for patients living with Type 1 diabetes."

This collaboration highlights the shared commitment of both companies to address the unmet needs of individuals living with T1D. By combining their expertise and leveraging complementary technologies, Sernova and Eledon aim to deliver a therapeutic solution that offers a durable and effective alternative to daily insulin injections and current immunosuppressive protocols.

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 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 T1D and thyroid disorders.

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