- 2022 revenues: €5.3 million
- Reduction of the annual operating loss
- Cash position of €4 million as of December 31, 2022
- Continued clinical development following the succession of
positive clinical results
Regulatory News:
ABIONYX Pharma, (FR0012616852 - ABNX - PEA PME eligible)
(Paris:ABNX), a new generation biotech company dedicated to the
discovery and development of innovative therapies for patients,
today announced its 2022 financial annual results as approved by
the full Board of Directors and an update on the activity to date.
The audit procedures on the consolidated accounts have been
completed. The certification report will be issued after completion
of the procedures required for the filing of the universal
registration document.
Selected financial information
(as of December 31, 2022/Consolidated financial statements under
IFRS)
M€
2022
2021
Revenues
5.3
0.7
Cost of goods and services sold
(4.6)
(0.4)
R&D expenditure
(1.1)
(3.8)
Administrative and commercial expenses
(3.7)
(2.3)
Other income and expenses
0
(0.1)
Operating Income
(4.1)
(5.9)
Financial income
0.2
0.3
Financial expenses
(0.3)
(0.2)
Financial result
(0.1)
0.1
Net income
(4.2)
(5.8)
Net cash flow from operating
activities
(3.4)
(6.7)
Net cash used in investing activities
(0.2)
1.3
Net cash flow from financing
activities
(0.2)
4.0
Change in cash and cash
equivalents
(3.9)
(1.4)
Cash and cash equivalents at end of
year
4.0
7.9
Details of the main changes in the consolidated financial
statements
Since the merger on December 1, 2021, with IRIS Pharma, the
Group has generated revenues from Services mainly related to two
types of services:
- Pre-clinical activities, representing revenues of €3,977K in
2022 compared to €143K for December 2021,
- Clinical activities representing revenues of €1,275K in 2022
compared to €505K for the month of December 2021.
Costs of goods and services sold amounted to €4,616K in
2022 corresponding to costs associated with pre-clinical and
clinical studies performed by IRIS Pharma.
Research and development expenses amounted to €1,107K for
the period, compared to €3,838K for the year 2021. The year 2022
saw the continuation of the activities initiated in 2021 marked by
clinical studies in renal indications and ophthalmology, and an
increase in personnel costs, notably due to the recruitment of
employees for the activities related to ophthalmology.
Administrative and selling expenses amounted to €3,661
thousand in 2022 compared to €2,336 thousand the previous year.
This increase is explained by the full year effect of the
integration of Iris Pharma in the scope of consolidation in 2022,
compared to only one month for the year 2021.
After taking into account all these elements, the operating
result went from a loss of €5,952K on December 31, 2021 to a
loss of €4,109K on December 31, 2022.
The financial result shows a deficit of 97 K€ at December
31, 2022, compared to a surplus of 130 K€ at December 31, 2021. The
2022 result is essentially composed of gains and losses realized
under the liquidity contract.
The net result is a deficit of 4,206 K€ at December 31,
2022, compared to a deficit of 5,822 K€ at December 31, 2021.
Cash and cash equivalents amounted to 4,046 K€ at
December 31, 2022, compared to 7,935 K€ at December 31, 2021.
2022 highlights
For a limited cash burn, the year 2022 was marked by tangible
results both for clinical trials, which all concluded with positive
results, and for regulatory advances.
End of the randomized Phase 2a study named RACERS which led
to positive clinical results
The randomized Phase 2a study named RACERS, a RAndomized study
comparing short-term infusions of CER-001 at different doses to
prevent induced acute kidney injury in high-risk sepsis patients,
was finalized in 2022. This clinical trial conducted in partnership
with the University of Bari and fully funded by the Consorzio per
Valutazioni Biologiche e Farmacologiche (CBVF) consortium concluded
with positive results for this Phase 2a clinical trial in the
treatment of patients with sepsis. These results validated a rapid
and sustained reduction in endotoxin levels, and a consequent
reduction in the inflammatory cascade compared to the standard of
care treatment alone. Endothelial biomarkers demonstrated a
significant protective effect of CER-001, as well as several trends
of reduced ICU days, reduced need for organ replacement, and
improved 30-day survival. No treatment-related side effects were
noted during the study.
Continued Clinical Trials in Ultra-Rare LCAT
Building on the positive clinical results of CER-001 in
ultra-rare LCAT disease that were published exclusively in the
Annals of Internal Medicine in March 2021, ABIONYX Pharma has
continued to supply its bioproduct for new Compassionate Access
Authorization (CAA) applications in 2022.
Orphan drug designation (ODD) obtained by the FDA
At the end of March 2022, following the Orphan Drug Designation
(ODD) obtained for its natural recombinant APOA-I from the European
Medicines Agency (EMA), ABIONYX Pharma announced that the Food and
Drug Administration (FDA) had granted Orphan Drug Designation (ODD)
for the treatment of LCAT deficiency in renal dysfunction and/or
ophthalmologic disease. The granting of ODD followed positive
results in two compassionate use cases that demonstrated for the
first time that APOA-I treatment can reduce lipid deposition in the
kidney, slow the decline in kidney function while eliminating the
need for dialysis, beneficially remodel lipoproteins, and mitigate
visual impairment due to corneal lipid deposition.
Strategic integration of IRIS Pharma for the development of
biomedicines in ophthalmology
Thanks to the positive clinical results in the treatment of
corneal lipid deposits and the integration of IRIS Pharma, ABIONYX
has become a specialist in ophthalmic biomedicines, in addition to
renal diseases, with a solid portfolio of drug candidates that can
enter the clinical phase and potential development in many
ophthalmic indications. IRIS Pharma, now a subsidiary of ABIONYX,
remains fully independent in its service activities for the largest
pharmaceutical and biotech groups in ophthalmology.
A strategic start to 2023
All the preclinical and clinical results for 2022 and the
beginning of this year foreshadow a new acceleration of the
development of natural APOA-I in severe renal diseases, which have
not seen any breakthrough innovation for a long time, and in
ophthalmology, for which the company will present its strategy by
the end of March.
About ABIONYX Pharma
ABIONYX Pharma is a new generation biotech company that aims to
contribute to health through innovative therapies in indications
where there is no effective or existing treatment, even the rarest
ones. Thanks to its partners in research, medicine,
biopharmaceuticals and shareholding, the company innovates on a
daily basis to propose drugs for the treatment of renal and
ophthalmological diseases, or new HDL vectors used for targeted
drug delivery.
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version on businesswire.com: https://www.businesswire.com/news/home/20230329005806/en/
NewCap Investor relations Louis-Victor Delouvrier Nicolas
Fossiez abionyx@newcap.eu +33 (0)1 44 71 98 53
NewCap Media relations Arthur Rouillé abionyx@newcap.eu
+33 (0)1 44 71 94 98
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