- Cash position of €9.1 million at February 29, 2020
- ABIONYX Pharma announces a named patient Temporary
Authorization for Use (ATUn) for CER-001 in Italy
Regulatory News:
ABIONYX Pharma (FR0012616852 - ABNX - PEA PME eligible),
a new generation biotech company dedicated to the discovery and
development of innovative therapies for patients, today announced
its full-year 2019 financial results and an update about
activities.
Selected Financial Information (At December 31, 2019 / IFRS
Consolidated accounts)
Millions €
2019
2018
Revenue
0
0.2
R&D expenditures
-0.7
-4.3
Administrative, sales and marketing
expenses
-1.8
-2.9
Operating income
-2.5
-7.1
Financial income
4.8
1.0
Financial expense
-0.4
-0.3
Net financial items
4.4
0.7
Net income
1.8
-6.3
Net cash flows related to operating
activities
-3.9
-6.0
Net cash flows related to financing
activities
0.8
1.2
Cash position variation
-3.1
-4.8
Cash and cash equivalents at the end of
the period
8.3
11.5
Details of the main changes in the consolidated financial
statements
As ABIONYX Pharma's activities are dedicated to the discovery
and development of innovative therapies to improve patients' lives,
the company did not generate any sales in fiscal year 2019.
Research and development expenses amounted to € 744 K
over the period, compared to € 4,295 K in fiscal year 2018. This
level of expenditure reflects the temporary termination of R&D
studies following the failure of the CARAT and TANGO clinical
trials and the reduction in R&D personnel costs as part of the
restructuring plan finalised in the first half of 2019. The company
has focused on exploratory studies for the valuation of its
existing assets.
General and administrative expenses amounted to € 1,781 K
in 2019 compared to € 2,931 K in the previous year, expenses which,
at the time, were impacted by the depreciation and amortization
charges and provisions relating to the job protection plan.
After taking into account all these elements, the operating
income shows a loss of € 2,525 K at December 31, 2019, compared
to a loss of € 7,052 K one year earlier.
Following Bpifrance's waiver of a debt related to the total
technical failure of the ISI "Apotheosis" project for which a
repayable advance had been granted, financial income of €
4,603 K was generated over the first half of 2019. As a result,
financial income amounted to € 4,412 K compared to € 747 K in
2018.
After taking into account the financial result, the net
income amounted to € 1,849 K at December 31, 2019 against a
loss of € 6,305 K at December 31, 2018.
Cash and cash equivalents amounted to € 8,331 K at
December 31, 2019. After receipt of the 2018 CIR at the beginning
of the year, cash and cash equivalents amounted to € 9,125 K on
February 29, 2020.
Update about activities
As of January 8, 2020, the company announced that it received a
named patient Temporary Authorization for Use (“ATU nominative”)
for CER-001 in an untreated, ultra-rare renal disease in
France.
In February 2020, the company received a named patient Temporary
Authorization for Use (“ATU nominative”) for CER-001 in an
untreated, ultra-rare renal disease in Italy.
As part of its strategy to focus on existing assets and given
the current availability of CER-001 vials, ABIONYX Pharma has
committed to supply the product free of charge over a period of
three months for these two ATUn.
In Italy, the use of proprietary drugs that do not yet benefit
from a market authorization (AMM) and that are not the subject of a
clinical trial, are subject to obtainment of a named patient
Temporary Authorization for Use from an ethics committee related to
Italian Drug Safety authorities. The current data do not allow
presumption of a favourable benefit-risk ratio for the use of
CER-001 in the context of this named patient Temporary
Authorization for Use.
In particular, a named patient Temporary Authorization for Use
is granted under the following conditions:
- The product is meant to treat, prevent or diagnose a severe or
rare disease,
- There is no appropriate treatment available on the market,
with no possibility to include a patient in an ongoing clinical
trial,
- The ATUn is delivered at the request and under the sole
responsibility of the prescribing physician, when the drug is
likely to benefit to the patient.
In light of the ongoing ATUn, the Company is awaiting clinical
data that may influence the determination of the new strategic
plan. In the current context of healthcare systems impacted by the
Coronavirus, the Company cannot commit to a specific timeline but
will return to the financial community as soon as possible.
About ABIONYX Pharma:
ABIONYX Pharma is a new generation biotech company dedicated to
the discovery and development of innovative therapies for patients.
The biotech assets inherited from CERENIS Therapeutics constitute a
rich portfolio of valuable programs for the treatment of
cardiovascular diseases and associated metabolic diseases as well
as a HDL targeted drug delivery platform in oncology, more
specifically in immuno-oncology and chemotherapy.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200310005860/en/
NewCap Investor relations Louis-Victor Delouvrier
abionyx@newcap.eu +33 (0)1 44 71 98 53
NewCap Media relations Nicolas Merigeau abionyx@newcap.eu
+33 (0)1 44 71 94 98
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