- Strategy built around two complementary development axes:
GMP Individualized Phage Therapies (IPT) and Phage Therapies
Medicinal Products (PTMP), to maximize access to phage therapy
care
- Acceleration of the deployment of the IPT model, achieved as
a first step by the strategic collaboration with Technophage,
enabling a significant expansion of the phage portfolio (25 GMP
phages by the end of 2025) to meet the clinical needs of
individualized therapies
- Continued development of the PTMP model through clinical
studies and the filing of new early access programs (AAC)
- Focusing current resource on the IPT model to generate
short-term revenue as early as in 2026 and target revenue of
approximately €20 million in 2027
- Expected regulatory approvals for the GLORIA study,
strategic asset for PHAXIAM's long-term development, from the EMA
(EU) and the MHRA (UK), followed by the launch of the clinical
study subject to future financial resources currently being
studied
- Cash position of €3.6 million as of December 31, 2024, and
active search for dilutive and non-dilutive financing to extend the
Company's cash runway beyond March 2025
Regulatory News:
PHAXIAM Therapeutics (Euronext: PHXM - FR0011471135), a
biopharmaceutical company (“PHAXIAM” or “the
Company”) developing innovative treatments for severe and
resistant bacterial infections, announced today an update on the
deployment of its ambitious strategy in the phage therapy market,
enabling it to maximize its development potential.
Thibaut du Fayet, Chief Executive Officer of PHAXIAM,
stated: “We start 2025 with a clear ambition to position PHAXIAM as
a Specialty Pharma in Critical care, in the booming phage therapy
market. By deploying our strategy around two complementary
development axes, Individualized GMP-Phage Therapies (IPT) and
Phage Therapies Medicinal Products (PTMP), we aim to maximize
patient access to these innovative treatments. The strategic
collaboration with Technophage is a major step forward on this
pathway, which should enable us to introduce individualized phage
therapy in key European hospitals and generate first revenue as
early as 2026, enabling us to target operating profitability at
end-2027. We are convinced that with this accelerated and dual
strategy, we will be able to radically change the way thousands of
patients suffering from severe, resistant bacterial infections are
treated in Europe.”
Accelerated development strategy in the
dynamic phage therapy market
Antibiotic resistance (AMR) is a critical global public health
issue, responsible for at least 1,270,000 deaths a year and,
according to the World Health Organization, could cause 10 million
deaths a year by 20501.
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 1st 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.
________________________ 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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version on businesswire.com: https://www.businesswire.com/news/home/20250130268564/en/
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
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