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Since its creation², PHAXIAM has been at the forefront of the fight against antibiotic resistance, thanks to its phage therapy approach and the development of a portfolio of phages targeting some of the most virulent bacteria (Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa).

In parallel with the clinical development of its phages, the Company has treated, with success and a demonstrated clinical benefit, more than 130 patients under compassionate status since 2018, mainly in France, but also in other European countries. This clinical momentum testifies to the strong demand from physicians for PHAXIAM phages, which are produced in pharmaceutical quality (GMP = Good Manufacturing Practice).

In this context of strong demand for phage therapy, PHAXIAM presented, in November 2024, a development strategy combining in parallel (1) the classical clinical development pathway (Phages Therapy Medical Product or PTMP) and (2) the commercialization of Individualized Phages Therapies (IPT) with GMP Phages. This dual development approach is widely used in other therapeutic fields, such as allergies, and is particularly well-suited to phage therapy.

PHAXIAM benefits from several key assets for the deployment of the IPT model, including established expertise in the selection of the most effective GMP phages for bacterial strains, thanks to its phagogram, a robust tool for guiding physicians in the choice of phage-based treatments.

The simultaneous development of PTMP and IPT models creates a virtuous circle for phage therapy:

• the commercial development in the IPT model will help finance PTMP programs and facilitate rapid uptake of future approved medicinal products;

• the clinical success in the PTMP model, from which the GLORIA clinical study in Prosthetic Joint Infections (PJI) has emerged, will strengthen the clinical and market acceptance of IPT therapies for clinical indications not yet covered by the PTMP approach.

Strategic collaboration with Technophage to accelerate the deployment of individualized GMP-phage therapy (IPT)

With the aim of fostering the emergence of phage therapy, PHAXIAM approached several players specialized in phage therapy, in Europe and North America. These discussions led to the finalization of a strategic collaboration with Technophage, a Portuguese company specialized in the development and manufacture of GMP phages, enabling the implementation of individualized phage therapy (IPT) through the pooling of their GMP phage portfolios.

By combining, (1) PHAXIAM's GMP phage portfolio and its advanced phagogram-based diagnostic capabilities, (2) with Technophage's GMP phage portfolio and GMP manufacturing expertise, this partnership aims to achieve a portfolio of 25 GMP phages by the end of 2025 and 35-45 GMP phages by the end of 2026. This expanded portfolio will target a minimum of 7 of the most critical pathogens, S. aureus, P. aeruginosa, E. coli, K. pneumoniae, A. baumannii, E. faecium and E. spp, which account for around 70%³ of resistant bacterial infections.

The IPT model, based on the extension of individualized treatments in European countries, should generate and secure revenue in the short and medium term, with potential revenue of around €20 million in 2027 and potentially around €100 million in 2030, by treating patients in the most important European countries. The aim is to generate these targeted revenues with a very marginal increase in the company's fixed costs, thanks to the redeployment of internal resources and expertise to the IPT model.

Continued development of the PTMP model through clinical studies and filing of new AAC applications

In parallel with the IPT model, PHAXIAM is pursuing PTMP clinical development. In particular, the Company continues to prepare the Phase II GLORIA study, the world's 1^st multicenter, randomized, placebo-controlled phage therapy study in Prosthetic Joint Infections.

PHAXIAM has already received IND approval from the US FDA in Q4 2024 and has also submitted the clinical protocol to the main European health authorities, including the EMA and the UK MHRA. Subject to these approvals, expected during the first half of 2025, the GLORIA study will be conducted in 7 European countries (France, Germany, the UK, Spain, Italy, the Netherlands, Sweden) and in the United-States, positioning it as one of the most robust and broadest phage therapy studies in the world.

Once these regulatory approvals have been obtained, the launch of the GLORIA study will depend on the company's future non-dilutive financial resources, currently being studied by the Company, and will be scheduled accordingly, possibly up to Q1 2026.

The Company is also continuing recruitment for its Phase I Pharmacokinetic study in endocarditis, targeting patients with resistant S. aureus infections in the heart chambers and valves. First clinical results are expected in mid-2025.

Finally, PHAXIAM also intends to extend the Compassionate Access Authorization (AAC) status available for its anti-S. aureus phages to other phages in its portfolio in 2025. Submission of the AAC for anti-P. aeruginosa phages, for Prosthetic Joint Infections, is expected by the end of January 2025.

Cash and cash equivalents of €3.6 million as of December 31, 2024

Cash and cash equivalents amounted to €3.6 million as of December 31, 2024. The said information is based on preliminary data not yet audited and will be the subject of communication on March 13, 2025, at the time of publication of the audited full-year results for the 2024 financial year. The Company believes that this cash position can finance its existing programs and planned operating expenses up to March 2025.

The Company is actively working on various dilutive and non-dilutive options to extend its cash runway beyond this timeframe, aiming for a minimum of 12 months of operations.

Outlook

The Company decided to allocate its existing and future financial resources primarily to accelerate its deployment in the IPT field, mainly by structuring the strategic partnership with Technophage, in order to generate commercial revenue in the short term, with the aim of achieving operating profitability in 2027.

About PHAXIAM Therapeutics

PHAXIAM is a biopharmaceutical company developing innovative treatments for resistant bacterial infections, which are responsible for many serious infections. The company is building on an innovative approach based on the use of phages, natural bacterial-killing viruses. PHAXIAM is developing a portfolio of phages targeting 3 of the most resistant and dangerous bacteria, which together account for more than two-thirds of resistant hospital-acquired infections: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa.

PHAXIAM is listed on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: PHXM). PHAXIAM is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.

For more information, please visit www.phaxiam.com

Forward-looking information

This press release contains forward-looking statements, forecasts and estimates with respect to the clinical programs, development plans, business and regulatory strategy and anticipated future performance of PHAXIAM and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. All statements contained in this press release other than statements of historical facts are forward-looking statements. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond PHAXIAM's control. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Investor should carefully read the risk factors section of the Company which can be found in the Company’s regulatory filings with the French Autorité des Marchés Financiers (AMF), including in the Company’s 2023 Universal Registration Document (Document d’Enregistrement Universel) filed with the AMF on April 5, 2024 and future filings and reports by the Company. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. PHAXIAM disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in PHAXIAM’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law.

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¹ Global burden of bacterial antimicrobial resistance 1990–2021: a systematic analysis with forecasts to 2050 (Lancet, Sept 2024)
² PHAXIAM is the result of the merger, in June 2023, between Erytech and Pherecydes Pharma, a biotech company founded in 2006, specializing in the development of innovative treatments for resistant bacterial infections.
³ ESKAPEE pathogens responsible for 70% of deaths attributable to AMR - Lancet 2024 (ESKAPEE pathogens: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter spp., Escherichia coli)

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Contacts

PHAXIAM
Thibaut du Fayet
CEO
+33 4 78 74 44 38
investors@phaxiam.com

NewCap
Mathilde Bohin / Dušan Orešanský
Investor Relations
Arthur Rouillé
Media Relations
+33 1 44 71 94 94
phaxiam@newcap.eu