Government of Canada Approval of Human Therapeutic Phage Enables a Critical First Step Towards Clinical Deployment and Creates Pathway to Multi-Phage Commercial Product

Winnipeg, May 8, 2025 — TheNewswire - Cytophage Technologies Ltd. (“Cytophage” or the “Company”) (TSXV: CYTO, FSE: 70G), a biotechnology company advancing precision bacteriophage therapeutics, announced today that it has received Government of Canada approval under the New Substance Notification (NSN) framework for its novel phage candidate targeting Enterococci for prosthetic joint infections (PJIs). 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, CEO 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 Roadmap 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 (“OLIP”/N of 1). Building on  past successes (see press releases March 1, 2024, April 2, 2024 and December 17, 2024) while maintaining phage product safety and efficacy, the Company’s roadmap includes expanding into multi-phage 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 (IND) application to support Phase 1 trials.

According to the Canadian Institute for Health Information (CIHI), 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 CAD $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 
Cytophage Technologies (TSXV:CYTO / FSE: 70G) 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 (AMR). The WHO 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 EU countries, US, Canada, Brazil, Bangladesh, India and Mexico. In addition to that, consumers all over the world are demanding organic and antibiotic-free products. 

Cytophage is using a de-risked 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.  

For more information on Cytophage Technologies and its innovative work in bacteriophage therapy, please visit www.cytophage.com.

For further information please contact:  

Heather Medwick, Chief Operating Officer 
heather@cytophage.com | 431 388 8873 

Cytophage Investor Alerts: https://cytophage.com/subscribe/

 

Cautionary Statement on Forward-Looking Information 

This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Cytophage to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Cytophage’s Filing Statement dated January 30, 2024, which is available for view on SEDAR+ at www.sedarplus.ca. These risks include but are not limited to, the risks associated with the bacteriophage industry, such as operational risks in development or capital expenditures, the uncertainty of extensive regulatory approval requirements, government regulations, protection of intellectual property, product liability and rapid technological advancements. Forward-looking statements contained herein are made as of the date of this press release, and Cytophage disclaims, other than as required by law, any obligation to update any forward-looking statements whether as a result of new information, results, future events, circumstances, or if management’s estimates or opinions should change, or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements.  

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