Cytophage Announces Fiscal Year End 2023 Results

(TheNewswire)

Winnipeg, April 30, 2024. Cytophage Technologies Ltd. (TSXV:CYTO) (“Cytophage” or the “Company”), the only publicly traded phage company that is focused on bacteriophage solutions for both animal health and human health, today released its fiscal year end results for the year ending December 31st, 2023. Cytophage’s audited financial statements and the Management Discussion and Analysis Report are available under the Company’s profile at sedarplus.com.

“2023 was an extremely busy year for Cytophage in terms of commercializing our key animal health products while also initiating all the necessary steps to take the Company public. Our growing operations have set us up for success in 2024.” said Dr. Steven Theriault, CEO of Cytophage.

The Company’s start to 2024 has already seen major accomplishments:

• Cytophage is the first phage company to go public in Canada.

• Cytophage is the first phage company to provide phage therapy in Canada for a prosthetic joint infection.

• Construction started on its new 20,000 sq ft facility that will include a state-of-the-art laboratory, GMP-certified manufacturing suite, administrative offices and warehouse space. It is expected to open in June 2024.

The Company’s main focus is on commercializing market-ready phage products for animal health, particularly to address Salmonella and E. coli in the poultry market. Cytophage continues to work with Renata Ltd. in Bangladesh to provide a bacteriophage solution that was developed specially to be effective and sustainable for poultry producers in the region, where environmental conditions (heat/humidity) can make disease control difficult. Cytophage’s innovative manufacturing breakthrough of lyophilizing phages provides a competitive advantage over other phage producers who offer only liquid products. The Company has been able to increase its product’s heat tolerance and shelf-life and make it even easier for producers to use while keeping manufacturing costs comparable to liquid production. Cytophage expects this breakthrough to allow for further innovation in developing new bacteriophage products.

Cytophage will expand its commercialization efforts in South Asia in 2024 where demographic and business conditions are quite favourable. Market research in this region has shown that vertically and horizontally integrated poultry operations are primed to evaluate and incorporate phage products into their feed, hatching, and broiler production processes. Cytophage’s customized, regional approach to phage development resonates with its goal to reduce the use of broad-spectrum antibiotics and replace them with more targeted phages. Business development for the first quarter focussed on marketing regionalized phage solutions directly to some of the largest, vertically and horizontally integrated poultry operations in the world that are in jurisdictions where phages are more readily accepted from both a business and a regulatory standpoint. Pursuing these companies will be key to 2024 business development efforts.

While commercializing animal phage products is the Company’s priority, Cytophage also developed its first human phage therapy for a compassionate use case. “We are proud of the recent landmark trial at The Ottawa Hospital and the use of our phages to treat an antibiotic-resistant bacterial infection affecting a prosthetic joint replacement patient,’ commented Dr. Theriault. Building on the success of this first treatment, Cytophage is currently exploring a limited number of other opportunities to provide life-changing therapies for people suffering from severe prosthetic joint infections.

Greater attention is being paid to the phage sector, with an increased number of compassionate use cases being highlighted in the media. In Canada, CBC and CTV did national news segments on Cytophage’s prosthetic joint infection phage therapy case. In the USA, CNN aired a show hosted by Dr. Sanjay Gupta that highlighted the promise of phages. Recent activities (financings and M&A deals) involving human health phage companies such as Armata Pharmaceuticals, BiomX, and Adaptive Phage Therapy, brought international attention to the sector. These important transactions demonstrate the growing attractiveness and acceptance of the use of phages to address health challenges. As Dr. Theriault stated: “I strongly believe that Cytophage is uniquely positioned to play a leading role in commercializing the scientific advancements of our phage products and combating the global problem of antibiotic resistance.”

2023 Milestones

1. Animal Health Division

• Cytophage entered into a Distribution Agreement with Renata Limited-Animal Health Division in Dhaka, Bangladesh (“Renata”) for the distribution of Cytophage’s animal health products by Renata in Bangladesh, Myanmar, Nepal and Sri Lanka.

• Cytophage submitted its first ever GRAS notice to the Office of Food Additive Safety of the FDA, which such notice concluded, through scientific procedures, that the phage cocktail targeted for use on chicken meat is generally regarded as safe and is not subject to pre-market approval requirements for use in food.

• The Company then proceeded to submit its first ever LONO to the Health Products and Food Branch of Health Canada to review the use of its phage product targeted for use on chicken meat as an antimicrobial food processing aid to reduce Salmonella on the surface of raw, skinless and boneless poultry meat.

• Cytophage completed a number of studies related to its poultry phage product for addressing Salmonella and E. coli infections in chickens. The studies showed that the product not only reduced the lethality and decreased the transmission of the bacteria in broiler chicken and layer hens, it resulted in healthier and heavier birds that were ready for market sooner than untreated birds. These studies include:

  • ooEvaluating the poultry phage product’s ability to reduce Salmonella transmission. The study showed that, in broiler chickens, the phage product removes the lethal effect of Salmonella and E. coli and decreases transmission of bacterial infections within the flock. The result was healthier chickens and increased weight gain.

  • ooEvaluating the ability of the phage product to protect layer hens from Salmonella and E. coli. The study results showed that the phage product removed the lethal effect of Salmonella and E. coli. As well, it decreased colonization in birds if an infection was present and decreased transmission of bacterial infection within the flock.

  • ooEvaluating the ability of the phage product to protect broiler chickens from Salmonella and E. coli in Bangladesh. The study found that the treated birds were healthier and heavier than untreated birds. Further, mortality was decreased by more than 20%.

• Evaluating the Clostridium perfringens phage product in poultry. Cytophage developed an animal model for lethality which then allowed for testing of its phage product against necrotic enteritis disease in broilers. The study showed that necrotic enteritis disease severity is reduced in broiler chickens infected with Clostridium perfringens when using the phage product.

• Evaluating the ability of the phage product to reduce Salmonella on experimentally contaminated chicken meat. The study results showed that the phage product significantly reduced the viable Salmonella population when applied to contaminated skinless, boneless chicken meat.

1. Human Health Division

In late 2023, Cytophage was contacted by physician, infectious diseases clinician-scientist Dr. Marisa Azad (Principal Investigator), who had a patient suffering from an antibiotic resistant infection associated with a prosthetic joint replacement. A treatment plan was developed and approved by The Ottawa Hospital Research Institute and Health Canada through the Open Label Individual Patient Trial (N of 1) in 2024.

1. Corporate Developments

• During Q2 of 2023, the Company began laying the groundwork for a planned initial public offering in early 2024. In May, Cytophage entered into a Letter of Intent with Cuspis Capital III Ltd. to complete a business combination and concurrent financing.

• In May, Cytophage secured a 20,000 sq. ft. facility that will be renovated to be its worldwide headquarters and is expected to open in June 2024.

• In November, Cytophage, Cuspis Capital III Ltd. and 10179321 Manitoba Ltd., a wholly-owned subsidiary of the Cuspis Capital III Ltd., entered into a business combination agreement.

• In December, the Company finalized the financing for gross proceeds of $2,500,000 which was in addition to the $522,000 financing closed in the summer of 2023.

For further information please contact:

Heather Medwick

Chief Operating Officer

heather@cytophage.com

431 388 8873

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

About Cytophage Technologies

Cytophage Technologies (TSXV:CYTO) is a pioneering biotechnology company dedicated to bacteriophage research, product development and commercialization. Committed to addressing the global challenge of antibiotic resistance, Cytophage advances innovative products that harness the power of bacteriophages to combat bacterial infections affecting human health, animal health, and food security.

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.

Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this news release.

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