PHAXIAM Announces 2023 Full-Year Results and Provides Business
Update
Conference call and webcast (English) on
Thursday, March 21, 2024
at 9:30am ET / 2:30pm CET
- Ongoing
clinical efforts boding well to create a global phage-therapy
leader in high-value indications
- First clinical
results of the Phase 1 study in Endocarditis Infections expected in
the second half of 2024
- Plan to launch the
1st global Phase 2 Proof-Of-Concept study in Prosthetic
Joint Infections (PJI) in early 2025, leveraging on PhagoDAIR
study
-
Compassionate access program continues to gain momentum
with the treatment of around 100 patients suffering from
Staphylococcus aureus
and Pseudomonas
aeruginosa
infections
- Cash and
cash equivalents of €10.5 million ($11.6 million) as of December
31, 2023
Lyon (France) and Cambridge (MA, US),
March 20, 2024, at 6 pm CET – PHAXIAM Therapeutics
(Euronext: PHXM; FR0011471135), a biopharmaceutical company
developing innovative treatments for severe and resistant bacterial
infections, today provides a business and financial update for the
fiscal year 2023.
“2023 was a pivotal year for our
development, shaped by the creation of PHAXIAM as a pure player in
a very promising field of phage therapy.” stated
Thibaut du Fayet, Chief Executive Officer of PHAXIAM
Therapeutics. “In this rapidly evolving therapeutic
space, driven by the growing challenges of antimicrobial
resistance, our strategic focus is on the most resistant bacterial
infections, and primarily those related to Staphylococcus
aureus. We are therefore pleased to be in close discussions
with potential pharma partners and global health authorities, which
both confirm the relevance of our strategy. More specifically, the
recent feedback received from the FDA and the EMA provide us with
clear guidelines for the design of our next global Phase 2 study in
Prosthetic Joint Infections. Furthermore, we are about to start the
evaluation of our anti-Staphylococcus aureus phages in the
endocarditis infections in France. Together, with the growing body
of clinical data from the Compassionate and Early-Access
treatments, we hope that we can successfully execute our clinical
plan with anti-Staphylococcus aureus phages. The field is
clearly moving fast forward, as shown by recent global deals, and
we are well positioned to become a leading phage-therapy player
able to address the most critical indications for which there is
currently no relevant solution, particularly for Prosthetic Joint
Infections, for which we are frontrunners.”
MARKET HIGHLIGHTS
Phage therapy sector in a spotlight with
recent M&A and refinancing deals
On March 6, 2024, BiomX, a clinical-stage
phage-therapy company, announced the acquisition of Adaptive Phage
Therapeutics (APT), concurrently with a private placement financing
of $50 million, involving several top-tier institutional investors
(Deerfield, Orbimed). In the meantime, Armata Pharmaceuticals
announced a $35 million refinancing deal.
These important transactions demonstrate the
growing attractiveness of phage therapy, where PHAXIAM has a
prominent role with its unique and leading positioning in
Prosthetic Joint Infections (PJI), as the most advanced Phage
therapy player in Europe.
BUSINESS HIGHLIGHTS
a) Confirmed strategic focus
on Phage Therapy in high-value indications with a strong
competitive position
PHAXIAM has been refocusing its clinical development programs in
indications of high medical needs, mainly for patients with severe
and resistant Staphylococcus aureus (S. Aureus)
infections, often associated with high mortality and budget
impact.
This is particularly the case for PJI, where
PHAXIAM has a reinforced strategic and leading position. With the
signs of clinical activity, we are observing in our compassionate
and early-access (AAC, Autorisation d’Accès Compassionnel – the
French early access program) patients, and a best-suited approach
of local administration of phages allowed in this indication, we
strongly believe that PJI is the best option to bring phages as
soon as possible as a first indication toward proof-of-concept and
registration.
Beyond PJI, as lead indication, PHAXIAM has
launched another strategic clinical study (Phase I PK) in
Endocarditis infections, reinforcing its ambition to be a leader in
innovative therapies to those patients who failed traditional
antimicrobial treatments.
b) Significant progress in
Clinical and Regulatory strategy for the S.
aureus program
- Prosthetic Joint Infections
(PJI): set for the first global Phase 2 study potentially enabling
an Early Access Pathway in Europe
- Leveraging on promising activity
signals from real-life compassionate treatments and valuable
insights from the current PhagoDAIR pilot study, PHAXIAM is
preparing the initiation of the 1st global (EU/US) Phase
2 study for PJI patients (Hip or Knee prosthesis) having an
open-surgery debridement (DAIR) in combination with
antibiotics.
- PHAXIAM has received positive and
consistent feedback from both the FDA (Pre-IND meeting) and the EMA
(Scientific Advice) with a view to launching this large-scale
study, including the following key points and recommendations:
- Confirmation of the value of a
clinical development in this indication;
- Confirmation that PHAXIAM’s
non-clinical data and CMC capabilities support a formal clinical
development plan in Europe and in the United States;
- Confirmation of the target
population and the Standard of Care to be considered; the
exclusion/inclusion criteria allow to target a population
approximately 6 times larger compared to the current PhagoDAIR
study;
- Clear and consistent guidelines and
expectations in terms of CMC and clinical endpoints.
- PHAXIAM considers (1) accelerating
the transitioning of PJI clinical development effort into the new
and more ambitious global Phase 2 proof-of-concept study, (2)
providing PhagoDAIR pilot study clinical data at the end of
2024.
- The Phase 2 proof-of-concept study
is intended to be a multicentric, randomized, double-blind trial
and is expected to include 100 patients in Europe and the US.
PHAXIAM intends to file a Clinical Trial Application (CTA) with the
EMA and the FDA in mid-2024 in view of starting patient enrollment
in early 2025.
- Upon a successful completion of
this clinical study (2H 2026), PHAXIAM may potentially open an
Early Access Pathway for the registration of a first phage therapy
treatment for PJI in Europe.
- Endocarditis Infections
(EI): initiate a 2nd
clinical study in an indication targeting vital cardiac
valves infections
- PHAXIAM has obtained approvals from
the French ANSM and South-East II-Lyon Ethics Committee to launch a
phase 1 study (PK data) in Endocarditis Infections caused by S.
aureus, to evaluate the safety of intravenous administration
(IV) of its anti-S. aureus phages.
- The study, conducted in 5 French
hospitals, is about to start and should enroll 12 patients
requiring replacement of an infected heart valve.
- First clinical results are expected
in H2 2024. If positive, these results could allow PHAXIAM to (1)
accelerate a clinical development in this indication and to (2) use
the IV administration for other indications requiring this
administration route, such as bacteriemia.
c) Robust real-life activity
data obtained from compassionate treatments
In June 2022, the ANSM granted PHAXIAM an AAC (Autorisation
d’Accès Compassionnel) and, to date, approximately 100
patients have already been treated under this regulatory status for
different indications, with a majority in PJI indication.
Data from the first 77 patients evaluated so far
show promising results with infection control at 3 months (clinical
endpoint), reaching approximately 80%, considered as a significant
improvement over standard of care (SoC) in this hard-to-treat
patient population with severe resistant infections, often
undergoing 2nd or 3rd line SoC antibiotic
treatment.
PHAXIAM has applied for a second AAC regulatory
validation, for PJI patients associated with P. aeruginosa
resistance. This AAC is currently being evaluated by the ANSM for a
potential final validation in 2024.
d) Partnering
options
As part of its strategic development strategy, PHAXIAM is
entertaining partnership discussions with pharmaceutical companies,
to investigate relevant collaboration options.
e) Complementary
Investigator-sponsored trials
In addition to PHAXIAM’s clinical activities, two French university
hospitals are preparing for Investigator-Sponsored Trials (IST)
with PHAXIAM’s phages. These studies are the opportunity for
PHAXIAM to potentially bring additional clinical POC data in other
high-value indications:
- Phase 2 IST in Diabetic Foot Ulcer
(DFU): this clinical study by Nîmes Hospitals, is targeting DFU
infections due to mono-bacterial S. aureus infection.
- Phase 2 IST in complex Respiratory
Tract Infections (VAP): this clinical study by La Pitié Salpêtrière
Hospital in Paris, is targeting nosocomial pulmonary infections due
to Pseudomonas aeruginosa, including patients
with ventilation-associated pneumopathies (VAP), a growing concern
in hospital environments.
Investigator-initiated studies are funded by hospital’s clinical
research programs and their execution and schedule are entirely
under the responsibility of the sponsoring centers.
FY 2023 FINANCIAL RESULTS
Key financial figures for the twelve months of
2023 compared with the same period of the previous year are
summarized below. In the context of the Erytech-Pherecydes merger,
PHAXIAM’s consolidated financial statements in IFRS standards
include ex-Pherecydes financial results as from the date of the
merger, i.e. June 23, 2023.
Consequently, PHAXIAM’s P&L information for
the full-year 2023 include 12 months of ex-Erytech activities and 6
months of ex-Pherecydes activities.
In thousands of euros |
|
FY2023
12 months
|
FY2022
12 months
|
Revenues |
|
— |
— |
Net income
from asset sale |
|
|
24,351 |
Other
income |
|
1,326 |
6,647 |
Operating income |
|
1,326 |
30,998 |
Research and
development |
|
(10,910) |
(19,907) |
General and
administrative |
|
(14,076) |
(13,887) |
Operating expenses |
|
(24,986) |
(33,793) |
Operating income (loss) |
|
(23,660) |
(2,796) |
Financial
income |
|
474 |
4,453 |
Financial
expenses |
|
(511) |
(1,364) |
Financial income (loss) |
|
37 |
3,089 |
Income tax |
|
208 |
(521) |
Net loss |
|
(23,488) |
(227) |
Operating expenses of €25.0 million in the
full-year 2023 were €8.8 million lower (-26%) than in the previous
year.
The decrease was driven by the reduction of
ex-Erytech R&D expenses, mostly related to the closing of
Princeton operations and the termination of clinical development
activities, while new ex-Pherecydes development activities were
integrated in the P&L as of 2H 2023. Overall, R&D expenses
were reduced by €9.0 million (-45%) year-over-year. PHAXIAM’s
G&A expenses in the full-year 2023 were stable year-over-year
(+€0.2 million, i.e. +1%), including one-off expenses related to
the merger and integration activities.
Net loss for the full-year 2023 was €23.5
million, compared with a net loss of €0.2 million for the same
period of 2022, which benefited from the €24.4 million net gain on
the sale of the Princeton facility in April 2022.
As of December 31, 2023, PHAXIAM had cash and
cash equivalents totaling €10.5 million (approximately $11.6
million), compared with €38.8 million as of December 31, 2022. The
€28.3 million decrease in cash position during the twelve months of
2023 was the result of a €24.3 million net cash utilization in
operating activities and investing activities and €3.7 million used
in financing activities, mostly related to the reimbursement of the
‘PGE’ Covid-loan, while the variation of the U.S. dollar against
the euro led to a €0.3 million negative currency exchange
impact.
The current cash position can fund PHAXIAM’s
programs and planned operating expenses into September 2024.
EFFECTIVENESS OF VOLUNTARY DELISTING OF AMERICAN DEPOSITARY
SHARES FROM NASDAQ STOCK MARKET
On March 11, 2024, PHAXIAM announced that the
Company’s voluntary delisting of American Depositary Shares
(“ADSs”) representing its ordinary shares from The Nasdaq Capital
Market had become effective. This delisting significantly reduces
PHAXIAM’s cash utilization and enables the Company to focus its
financial resources on key development and value milestones.
The Company remains listed on Euronext Paris as
its primary trading market and intends to continue its disclosures
in compliance with applicable French financial market
regulations.
KEY NEWSFLOW AND MILESTONES EXPECTED
OVER THE NEXT 12 MONTHS
- First Patient-In for Phase 1 study
in EI (2Q 2024)
- CTA filing for the global Phase 2
study in PJI (3Q 2024)
- Global Phase 2 study in PJI
Approval (4Q 2024)
- PhagoDAIR pilot study in PJI
clinical data (end 2024)
- Preliminary PK data from the Phase
1 study in EI (2H 2024)
- Launch of the global Phase 2 study
in PJI (early 1Q 2025)
FY 2023 CONFERENCE CALL
DETAILS
PHAXIAM management will hold a conference call
and webcast on Thursday, March 21, 2024, at 9:30am ET /
2:30pm CET on the 2023 Full-Year results and Business
Update. Thibaut du Fayet, CEO, Eric Soyer, COO/CFO and Pascal
Birman, CMO, will deliver a brief presentation in English, followed
by a Q&A session.
The audio call is accessible via the below registering link:
https://register.vevent.com/register/BIc5665a54501d4da0860376430792d4f5
Once registered, participants will receive a
unique access code and the call number details to join the
teleconference.
The webcast can be followed live online via the
link: https://edge.media-server.com/mmc/p/3wxbu7c7
In addition, the replay of the webcast will be
available for a period of one year on this same link.
FINANCIAL CALENDAR
- Update on business and key
financial data for Q1 2024: May 15, 2024 (after market close)
- Annual General Meeting on June 28,
2024
***
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
Contacts
PHAXIAM
Eric Soyer
COO & CFO
+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 |
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. Important factors that could
cause actual results and outcomes to differ materially from those
indicated in the forward-looking statements include, among others,
the following: (1) the inability to maintain the listing of
PHAXIAM’s shares on the Nasdaq Capital Market and the Euronext
regulated market; (2) changes in applicable laws or regulations;
(3) the possibility that PHAXIAM may be adversely affected by other
economic, business and/or competitive factors; and (4) other risks
and uncertainties indicated from time to time in PHAXIAM’s
regulatory filings. Further description of these risks,
uncertainties and other risks can be found in the Company’s
regulatory filings with the French Autorité des Marchés Financiers
(AMF), the Company’s Securities and Exchange Commission (SEC)
filings and reports, including in the Company’s 2022 Universal
Registration Document (Document d’Enregistrement Universel) filed
with the AMF on March 28, 2023 and in the Company’s Annual Report
on Form 20-F filed with the SEC on March 28, 2023 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. Readers are cautioned not to
place undue reliance on any of these forward-looking statements.
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.
- PR_PHAXIAM_FYR-2023_EN_VF
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