Sernova Biotherapeutics Inc Stock Price, News & Analysis

Sernova Biotherapeutics (SEOVF), a regenerative medicine company developing Cell Pouch Bio-hybrid Organ for type 1 diabetes treatment, announced the resignation of its Board Chair, Ross Haghighat. The resignation was tendered on May 24th, 2025, and accepted by Sernova's Board of Directors. The company expressed gratitude for Haghighat's leadership and extended well wishes for his future endeavors.

Sernova Biotherapeutics (SEOVF) has secured a CAD$4 million secured term loan from Navigate Private Yield Fund LP III, maturing on April 16, 2026. The company, which focuses on developing Cell Pouch Bio-hybrid Organ as a functional cure for type 1 diabetes (T1D), will use the proceeds for working capital and general corporate purposes.

The loan, supported by a secured guarantee from Sernova's U.S. subsidiary and board member Dr. Steven Sangha, comes after raising over CAD$10 million in recent months. The company is preparing to initiate its final human donor islet Cohort C clinical trial of their Cell Pouch Bio-hybrid Organ in T1D patients, positioning itself as the most advanced company in U.S. clinical trials with an implantable and retrievable product targeting type 1 diabetes cure.

Sernova Biotherapeutics (TSX: SVA) (OTCQB: SEOVF) announced that its Cell Pouch Bio-hybrid Organ, in development as a functional cure for type 1 diabetes (T1D), will be featured at the 2025 Cell & Gene Meeting on the Med conference in Rome.

The presentation will be part of a panel discussion titled 'Diabetes – Cell and Tissue Therapy Approaches to Provide Durable Therapeutic Solutions' on April 16, 2025. Dr. Bernd Muehlenweg, Senior Vice President at Evotec and Non-Executive Director at Sernova, will present data from the Sernova-Evotec collaboration during the session.

Sernova Biotherapeutics (SEOVF) has received DSMB approval to advance its Phase 1/2 clinical trial for type 1 diabetes treatment using the Cell Pouch™ Bio-hybrid Organ system. The trial's Data and Safety Management Board has authorized enrollment of the final patient in Cohort B, with plans to progress to Cohort C in H2 2025.

The primary endpoint focuses on demonstrating safety and tolerability of islet transplantation into Cell Pouch for T1D patients with hypoglycemia unawareness. The company reports being on track to achieve this endpoint based on current clinical data.

The Cell Pouch™ system, described as the only implantable and retrievable cell containment system for islet engraftment in U.S. clinical trials, has shown islet cell survival in patients ranging from one to five years, with demonstrated ability to support insulin independence. Following trial completion, Sernova plans to initiate a new clinical trial using iPSC islet-like clusters in collaboration with Evotec.

Sernova Biotherapeutics (OTCQB: SEOVF) has appointed Dr. Pericles (Perry) Calias as Chief Development Officer and Head of R&D. Dr. Calias brings over 20 years of global operational experience in drug product development, having previously held leadership positions at Revolo Biotherapeutics, Cerecor Inc., Sucampo Pharmaceuticals, and Shire HGT.

Dr. Calias will contribute to advancing Sernova's Cell Pouch Bio-hybrid Organ, which is being developed as a functional cure for type 1 diabetes (T1D). His expertise includes securing regulatory approvals, leading R&D efforts, patent applications, clinical operations, and advancing therapies in rare diseases, autoimmune disorders, CNS disorders, and drug-device combinations.

He holds a Ph.D. in Bio-Organic Chemistry from Tufts University and is an inventor on over 40 domestic and foreign patents. His experience includes successful regulatory filings of INDs, CTAs, PMAs, BLAs, and NDAs.

Sernova Biotherapeutics (SEOVF) has secured a CAD$1 million unsecured convertible debenture financing from board member Dr. Steven Sangha. The debenture, maturing on March 4, 2027, carries a 15% interest rate and is convertible into common shares at CAD$0.20 per share.

The company also issued 5 million non-transferable share purchase warrants, exercisable at CAD$0.20 per share until March 4, 2028. The financing proceeds will be used for working capital. The transaction, classified as a 'related party transaction,' is exempt from formal valuation and minority shareholder approval requirements as it represents less than 25% of the company's market capitalization.

Sernova Biotherapeutics (SEOVF) has received FDA clearance for its Investigational New Drug (IND) application to evaluate the Cell Pouch bio-hybrid organ with auto-transplanted thyroid cells in patients undergoing thyroid surgery. The therapy aims to treat hypothyroidism in patients post-thyroid surgery.

The Cell Pouch system, combined with autologous thyroid cell therapy, is designed to restore natural thyroid function without requiring thyroid hormone replacement medications or immune suppression therapy. Preclinical studies have shown successful restoration of primary thyroid hormones (T4 and T3) to pre-thyroidectomy levels when thyroid tissue was re-implanted into the pre-vascularized Cell Pouch. Healthy, functional thyroid tissue was confirmed through radio-isotope imaging and histological analysis up to five months post-implantation.

Sernova Biotherapeutics (SEOVF) has submitted an Investigational New Drug (IND) application to the FDA for its Cell Pouch bio-hybrid organ with autologous thyroid cells to treat hypothyroidism in patients undergoing total thyroidectomy. The technology aims to restore natural thyroid function without requiring immune suppression therapy.

Preclinical trials have shown promising results, demonstrating that reimplanting thyroid tissue into the pre-vascularized Cell Pouch restored thyroxine (T4) and triiodothyronine (T3) hormones to pre-thyroidectomy levels without hormone supplementation. Imaging and histology confirmed functional thyroid tissues within the Cell Pouch five months post-reimplantation.

Upon FDA clearance, Sernova plans to initiate a first-in-human clinical trial to evaluate safety, tolerability, and efficacy in patients undergoing thyroidectomy for benign nodular disease.