Biotech Firm Unveils Diabetes Breakthrough in Canada

1. Sernova Biotherapeutics Inc. has a consulting relationship with Street Smart an affiliate of Streetwise Reports. Street Smart Clients pay a monthly consulting fee between US$8,000 and US$20,000.
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Sernova Biotherapeutics Inc. (SVA:TSX.V; SEOVF:OTCQB; PSH:XETRA) has announced the formation of a Clinical Advisory Board composed of leading experts in diabetes care, islet cell transplantation, and regenerative medicine. The announcement was made on May 22, 2025, as the company continues development of its Cell Pouch Bio-hybrid Organ for treating type 1 diabetes (T1D).

Dr. Robert Gabbay, Associate Professor at Harvard Medical School and former Chief Medical Officer of the Joslin Diabetes Center and the American Diabetes Association, will chair the new five-member board. Dr. Gabbay’s research has been supported by major institutions such as the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Agency for Healthcare Research and Quality (AHRQ).

Other members include Dr. Mark Atkinson, Director of the University of Florida Diabetes Institute, known for over 750 scientific publications on T1D; Dr. Melena Bellin, a leader in clinical islet transplantation at the University of Minnesota; Dr. Andrew Posselt of UCSF Medical Center, who directs the Pancreatic Islet Transplant Program; and Dr. Holger Russ, an expert in stem cell biology and autoimmune diabetes at the University of Florida.

Sernova CEO and President Jonathan Rigby stated in the news release, “We are truly honored to welcome such a renowned group of clinical and scientific leaders that believe in our mission... Their collective expertise in T1D care, islet transplantation, islet cell biology, immunology, and clinical trial execution is of great value to Sernova and the patients we serve.”

Sernova’s Cell Pouch is an implantable, biocompatible device designed to house therapeutic cells and restore hormonal balance in T1D patients. Unlike standard insulin therapy, which requires daily injections or pumps and constant glucose monitoring, the Cell Pouch aims to re-establish natural insulin production using transplanted islet cells.

The company’s ongoing Phase 1/2 clinical study has shown encouraging results. In Cohort A, all six patients receiving islet cell transplants into the Cell Pouch achieved insulin independence for durations ranging from 18 months to over four years. Follow-up data showed sustained cell survival and functionality over five years post-implantation.

Sernova is also developing a next-generation version of the therapy in partnership with Evotec, combining the Cell Pouch with induced pluripotent stem cell (iPSC)-derived islet-like clusters. These clusters are designed to replicate the function of native pancreatic islets, including the secretion of insulin, glucagon, and somatostatin. These are all critical hormones in blood sugar regulation.

Biotech Sector Faces Economic Strains and Talent Disruptions

The U.S. biotechnology sector has recently faced increasing operational and strategic pressures, driven by economic policy shifts, workforce instability, and changing global dynamics. These challenges are shaping the environment in which clinical-stage companies operate, with implications for research, development, and long-term competitiveness. Fortune Business Insights, on May 5, reported that the global diabetes drugs market size was valued at USD 88.32 billion in 2024. The market is projected to grow from USD 101.48 billion in 2025 to USD 233.84 billion by 2032, exhibiting a CAGR of 12.7% during the forecast period. Some of the key players in the market include Novo Nordisk A/S, Eli Lilly & Company, and Sanofi. These companies hold a major portion of the global diabetes drugs market. North America dominated the diabetes drugs market with a market share of 49.95% in 2024.

Beyond traditional pharmaceutical strategies, companies like Sernova Biotherapeutics are advancing device-based approaches to diabetes treatment, adding new dimensions to the sector. The Cell Pouch, an implantable device designed to house therapeutic cells, has demonstrated insulin-free outcomes in clinical trials. This innovation reflects a shift in the market toward regenerative medicine solutions, which could supplement or compete with pharmaceutical treatments.

A May 12 column in Clinical Leader further examined the implications of U.S. tariffs on the biotechnology industry. The piece cited a survey by the Biotechnology Innovation Organization (BIO), which revealed that nearly 90% of U.S. biotech companies depend on imported components for at least half of their FDA-approved products. The introduction of tariffs on imports from regions such as the European Union, China, and Canada has raised concerns about escalating manufacturing costs and disrupted supply chains. According to the survey, 94% of biotech firms expected cost increases from the April 2 tariffs on EU goods, while 80% said they would require at least a year to identify alternative suppliers. These supply pressures were also seen as contributing to investor hesitation, as higher manufacturing expenses and regulatory uncertainty weigh on R&D budgets.

DataHorizon Research on May 19, reported that the global oral anti-diabetes drugs market alone was valued at approximately USD 51.3 billion in 2023 and is expected to reach USD 90.2 billion by 2033, growing at a CAGR of 5.8%. The report identified the rising prevalence of diabetes and the demand for convenient, non-invasive treatment options as key growth drivers. Advances in sustained-release technologies, combination therapies, and precision medicine are helping reshape the therapeutic landscape.

These trends indicate the diabetes drugs market is not only expanding in size but diversifying in approach. As patient preferences evolve and healthcare systems prioritize integrated, long-term diabetes management, the convergence of biologics, devices, and digital health tools is expected to shape the next generation of treatment options.

Third-Party Expert Analysis Highlights Strong Potential for Sernova’s Cell Pouch

In an April 22 research note, Dr. Joseph Pantginis of H.C. Wainwright & Co. provided a highly favorable assessment of Sernova Biotherapeutics and its lead program, the Cell Pouch system, for type 1 diabetes (T1D). Pantginis emphasized that “Sernova is the only company in the space that has demonstrated positive patient outcomes in a trial combining donor islets and an implantable device” for patients with insulin-dependent T1D. He noted that patients in the company’s ongoing Phase 1/2 study achieved insulin independence and maintained hemoglobin A1c (HbA1c) levels in the non-diabetic range, calling these “clear efficacy signals.”

Pantginis highlighted that “deep responses in diabetes patients position the technology for potential commercial success,” adding that the Cell Pouch has demonstrated a consistent safety profile throughout the trial. The company received Data Safety Monitoring Board approval to continue its study, with a Phase 3 pivotal trial expected to follow. H.C. Wainwright maintained a Buy rating and a target price of CA$6 per share, citing the stock’s CA$0.21 trading price at the time as representing a potential 2,757% return.

In addition to its T1D program, Sernova has initiated a second clinical pathway using the Cell Pouch to treat hypothyroidism. The company submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration to evaluate the device in patients undergoing thyroid removal. Pantginis stated that preclinical studies showed sufficient recovery of thyroid hormone production, writing, “We think these results were a clear indication of the capacity of transplanted Cell Pouches to act similarly to the organ.” He also noted that hypothyroidism represents a US$2.2 billion market opportunity in the United States.

Looking ahead, Pantginis forecasted that the Cell Pouch could reach the U.S. market by 2027 with an estimated 25% chance of success and peak sales of US$2.3 billion. This projection assumed a modest 2.1% market penetration among the hypoglycemic unawares population but left room for significant upside given broader T1D prevalence and challenges in insulin supply and affordability. According to H.C. Wainwright, “visibility for the company should increase” as it advances the Cell Pouch across multiple indications.

Next Moves in Motion: Competitive Positioning and Clinical Expansion

Sernova’s H1 2025 investor presentation outlines several forthcoming catalysts that could shape its near-term trajectory. The company is nearing completion of Cohort B in its Phase 1/2 trial and plans to launch Cohort C in 2025. Each subsequent cohort builds on prior findings, with adjustments in immune suppression protocols and device configuration to optimize outcomes.

A key highlight from the study so far includes documented insulin independence in all Cohort A patients, a significant development for the roughly nine million people worldwide living with T1D. Sernova reported that these individuals maintained hemoglobin A1c (HbA1c) levels—the standard measure of long-term glucose control—within the non-diabetic range (≤ 6.5 percent) without requiring external insulin.

Looking ahead, Sernova intends to initiate a clinical program in 2026 for its iPSC-based Cell Pouch product, developed in collaboration with Evotec. Preclinical studies in diabetic mice showed robust glycemic normalization and excellent intra-graft vascularization, both indicators of strong therapeutic potential.

Sernova has also signed a letter of intent with GoldTrack Ventures and the Kingdom of Saudi Arabia to support funding of the T1D program, adding further momentum to its commercialization pathway.

As the company expands its clinical footprint, the combination of expert advisory oversight, promising early clinical results, and international collaboration positions Sernova as a notable player in the regenerative medicine space focused on endocrine disorders.

Ownership and Share Structure

According to Refinitiv, about 4.1% of the company is held by insiders and management and approximately 0.05% by institutions. The rest is retail.

Top shareholders include Director Steven Sangha with 3.97%, Chief Financial Officer James Parsons with 0.12%, CATAM Asset Management AG with 0.05%, and Chief Business Officer Modestus Obochi with 0.02%.

Sernova has 328.48M outstanding shares and 315.01M free float traded shares. Its market cap is CA$49.5M. Its 52-week range is CA$0.15−CA$0.40 per share.