Dr. Steven Theriault reports

CYTOPHAGE TECHNOLOGIES LTD. SECURES GOVERNMENT OF CANADA NEW SUBSTANCE NOTIFICATION APPROVAL TO FACILITATE ENTEROCOCCUS PHAGE THERAPY TRIALS

Cytophage Technologies Ltd. has received government of Canada approval under the new substance notification framework for its novel phage candidate targeting enterococci for prosthetic joint infections. This initial regulatory milestone is a foundational step in Cytophage's broader clinical development strategy to create a combination phage treatment capable of addressing the multiple bacterial species commonly involved in PJIs.

Enterococci, particularly E. faecalis and E. faecium, are among the most challenging pathogens in orthopedic infections due to biofilm formation and antibiotic resistance (Journal of Medical Microbiology). Phage therapy offers a targeted, adaptive and biofilm-disruptive approach to treating such infections, particularly in patients for whom conventional antibiotics and surgeries have failed.

"Antibiotics continue to fail at an accelerated rate for chronic bacterial infections such as those in prosthetic joint infections, and the medical field is looking for safe and effective alternatives," commented Dr. Steven Theriault, chief executive officer of Cytophage. "This milestone accelerates our path to clinical validation and falls within our long-term commercialization strategy for human therapy. It allows us to move swiftly into patient-specific, compassionate use settings and ultimately scale into phase 1 trials. We believe this represents a paradigm shift in treating chronic and polymicrobial implant-associated infections."

Clinical road map and market opportunity

Following this NSN clearance, Cytophage is actively working with its clinical partners to identify candidate patients with unresolved enterococcus-based PJI of the hip or knee. These patients would be part of a series of single-patient, phage-based clinical trials. Building on past successes (see press releases dated March 1, 2024, April 2, 2024, and Dec. 17, 2024) while maintaining phage product safety and efficacy, the company's road map includes expanding into multiphage cocktails to address the broader spectrum of bacteria commonly found in PJIs and, eventually, for use in large-scale trials.

Following patient selection, treatment will include localized and systemic administration over 14 days, with clinical monitoring continuing for 12 months after therapy. Data collected will feed directly into a planned investigational new drug application to support phase 1 trials.

According to the Canadian Institute for Health Information, over 130,000 hip and knee replacements are performed annually in Canada. A review in the New England Journal of Medicine reported the lifetime cost of such an infection in the hip can cost over $540,000 in treatment and hospitalization. Cytophage aims to develop high-precision phage products to address these high costs and, most importantly, alleviate patient suffering.

About Cytophage Technologies Ltd.

Cytophage is a pioneering biotechnology company dedicated to bacteriophage research, product development and commercialization.

Bacteriophages are viruses that only infect and kill bacteria. These natural killers of bacteria can overcome cellular or organism-level defences. They are nature's version of antibiotics.

Cytophage is improving bacteria's natural predators with environmental, as well as genetic, modifications to bring safe and toxin-free killer solutions to large addressable markets with an initial focus on animal health, which offers a fast track to near-term revenue. As a leading bacteriophage manufacturer in Canada and powered by a large library of strains, Cytophage is committed to addressing the global challenge of antibiotic resistance. The World Health Organization predicts that AMR will be the leading cause of human mortality by 2050. Many countries have already banned or limited preventative antibiotic use in animal production, including 27 European Union countries, United States, Canada, Brazil, Bangladesh, India and Mexico. In addition, consumers all over the world are demanding organic and antibiotic-free products.

Cytophage is using a derisked and patented technology to advance innovative and cost-competitive products that harness the power of bacteriophages to combat bacterial infections affecting human health, animal health and food security.

We seek Safe Harbor.