- Cash position of €10 M on December the 31st 2023
- OPM-101 in inflammatory bowel disease: pursuit of Phase I in
healthy volunteers with multiple-dose escalation administration and
a very comfortable therapeutic margin in preparation for Phase IIa
in 2024
- OPM-201, licensed to Servier to treat Parkinson's disease:
pursuit of Phase I healthy volunteers with no issue in the
direction of MAD (multiple-dose escalation administration)
- A loss of €8.1 M, in line with our forecasts and with the
progress of our products and the development of our
technologies
- Strengthened cash position post-closing: €2 M fund-raising
in February 2024 and payment of €0.52 M as part of the DeepTech
financing granted for our ANIMUS program, resulting in a cash
visibility of more than 12 months
Regulatory News:
Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63;
Mnemonic: ALOPM), a biopharmaceutical company specializing in
precision medicine for the treatment of resistant and metastatic
cancer, has published its financial results for 2023, as approved
by the Board of Directors on 26 March 2024.
Philippe Genne, Chairman and CEO of Oncodesign Precision
Medicine, said: “One year after its launch, OPM and its teams
have achieved a number of significant achievements. Two compounds
based on OPM's Nanocyclix® technology have entered Phase I clinical
trials in healthy volunteers: OPM-201, licensed from Servier, for
Parkinson's disease, and OPM-101 for inflammatory bowel disease.
OPM-101 has a wide therapeutic margin and could enter Phase IIa at
the end of 2024, to be administered to patients suffering from
immune-induced colitis. OPM-201 is expected to enter Phase IIa in
patients with Parkinson’s disease in 2025. The StarT Pancreas
partnership with Servier to identify therapeutic targets for
pancreatic cancer has highlighted OPM’s skills in identifying and
validating biological targets using artificial intelligence (AI),
and the first therapeutic targets are beginning to emerge. Finally,
OPM has developed two industrial segments: Promethe for Molecular
Radio Therapy, and FederAidd for the application of AI to reduce
the development time of therapeutic molecules. We started 2024 by
raising funds, which you supported, and for which we thank you, and
it will help us to continue our development without losing too much
time. Since September 2022, OPM has raised more than €26 million
from industrial investors, bank loans and public funds. This
diversification of financing, during this period of persistent
stock market gloom, is a guarantee of success and proof of the
company’s ability to adapt to its environment. The completion of
the preclinical proof of concept for OPM-102 and the start of our
research into new drug candidates for systemic radiotherapy reflect
the refocusing of our business on oncology, an area in which we
excel.”
Karine Lignel, COO of Oncodesign Precision Medicine,
added: “With a cash position of €10 million at the end of 2023,
increased since then by the €2 million proceeds from the
fund-raising and the reception of €0.5 million from the grant and
recoverable advance as part of the ANIMUS (Deep Tech) program, OPM
has solid financial visibility until the beginning of 2025 for the
development of its programs. We have also received approval for a
FEDER financing program and are awaiting formalization of an
agreement as part of i-DEMO, for a total amount of public funding
that could reach nearly 8 million euros over the duration of the
projects.”
Oncodesign Precision Medicine – Income
Statement
in M€ Audited data
2023
2022
Evolution
in %
in value
Revenues
1.1
8.0
- 87%
- 6.9
Other revenues and operating income
0.7
0.3
+ 101%
+ 0.3
Total revenues and operating income
1.7
8.3
- 79%
- 6.6
Purchases consumed
(8.0)
(7.6)
+ 6%
- 0.4
Personnel costs
(3.3)
(2.1)
+ 59%
- 1.2
Other operating expenses
(0.1)
(0.1)
- 29%
+ 0.0
Taxes and duties
(0.1)
(0.0)
+ 74%
- 0.0
Net change in depreciation and
amortization
(0.3)
(0.2)
+ 55%
- 0.1
Total operating expenses
(11.7)
(9.9)
+ 18%
- 1.8
Operating result
(9.9)
(1.6)
na
- 8.3
Financial income and
expenses
0.1
(0.1)
na
+ 0.2
Extraordinary income and
expenses
0.0
(0.0)
na
+ 0.0
Income tax
1.8
1.5
+ 18%
+ 0.3
Net result
(8.1)
(0.2)
na
- 7.9
Overview of our development programs and technologies in
2023
In February 2023, we began clinical development of OPM-101 with
a phase I trial in healthy volunteers, started preclinical
development of OPM-102 in oncology, consolidated the Promethe
systemic radiotherapy platform (RIV), particularly with the
creation of the industrial chain in collaboration with the
Burgundy-Franche-Comté region, and continued to develop our 3rd
technology platform, OncoSNIPER (IA), based on two major programs:
OncoSNIPE® (PSPC), and StarT pancreas, in collaboration with
Servier.
2022 was a special year with the birth of OPM, and the figures
are therefore more difficult to compare with 2023.
Operating expenses are up by 18% compared with 2022, the year in
which OPM was created. Purchases consumed consist mainly of
subcontracting costs, which are up by 6%. Significant expenditure
has been allocated to the phase 1 trial of healthy volunteers for
our OPM-101 molecule, which is our number 1 priority. Other
expenses relate to early partnership programs (S-Engine and StarT
Pancreas), which represent revenue for 2023.
Oncodesign Precision Medicine – R&D
expenses
in M€ Analytical data
2023
2022
Evolution
in %
in value
Partnerships
2.1
2.9
- 3%
- 0.1
Licensing
6.7
4.1
- 7%
- 0.3
Total R&D expenses
8.8
7.0
- 5%
- 0.4
Investment in R&D programs increased by €1.9 M (+27%) to
reach €8.8 M in 2023, 40% of which is devoted to the clinical
development of OPM-101 (phase 1 Healthy Volunteers), 30% to the
preclinical development of OPM-102, and the remaining to the
further development of our OncoSNIPER® technology platform and the
implementation of the Promethe platform.
The increase in personnel costs is primarily due to the change
in organization: until September 2022 (the date of the OPM/ODS
separation), personnel costs were classified as “purchases
consumed” in respect of re-invoicing of services and reallocation
of costs, and not as “personnel costs”. A “full year” effect must
also be taken into account following the strengthening of the
scientific teams at the end of 2022: 2 program directors involved
in the clinical phase of OPM-101 and the development of
OPM-102.
In 2023, OPM generated sales of €1.1 M through development
partnerships with S-Engine (USA) and Servier Laboratories. In 2023,
unlike in 2022, OPM did not expect any up-front or milestone from
its collaboration programs, which account for the majority of OPM’s
sales. These revenues therefore fluctuate considerably from one
year to the next and are not the most relevant indicator for
assessing the company’s value.
Other income consists mainly of rent charged back to Oncodesign
Services for the head office, and the Transition Service Agreement
(TSA) signed with Oncodesign Services as part of the scission,
which expired in summer 2023.
OPM's financial income for 2023 was €0.1 M, compared with €(0.1)
M last year.
All available cash was invested in interest-bearing term
accounts, generating almost €0.3 M in interest. At the same time,
OPM spent €0.1 M servicing its debt.
It is important to note that OPM recorded €1.8 M in the French
Research Tax Credit in 2023 with R&D, up +19% compared to 2022,
directly linked to the increase in investments made on our
programs.
OPM's net loss for 2023 is €8.1 M, reflecting the financial
structure of a biopharmaceutical company in full development one
year after its creation.
Cash position of €10 M at 31 December 2023
As a reminder, the year 2023 started with €13.5 M of cash, after
which OPM obtained a €6 M bank loan in October 2023. This level of
cash demonstrated solid financial visibility for the months ahead
and enabled OPM to develop its programs during this period.
At 31 December 2023, the cash position was €10 M. At the
beginning of 2024, the net proceeds of the fund-raising of €2 M,
i.e. €1.734 M net, and the receipt of €0.52 M as part of the grant
and recoverable advance under the ANIMUS (Deep Tech) program, were
added to this cash position. This gives OPM financial visibility
until early 2025.
More than 57% of the company's capital is held by its management
and employees (46.65% by PCG, 7.46% by Jan Hoflack, 1.24% by Karine
Lignel and 1.64% by the remaining employees). This commitment is
rare in a company of this nature and demonstrates the strong link
between the interests of the company and those of its shareholders,
as well as the high level of confidence in the company's potential
demonstrated by its stakeholders.
2024 perspectives
The year 2024 started very positively and OPM is continuing to
develop, with the expectation of significant new revenues and
public funding, the rapid progress of phase I of OPM-101 and the
choice of a European industrial partner for our systemic
radiotherapy platform.
This year should also see further development of our two drug
candidates, including the possible entry of OPM-101 into phase IIa,
and the entry of OPM-102 into preclinical trials.
Availability of the 2023 annual financial report
The 2023 Financial Report will be available on the company's
website on 25 April 2024. The work of the Statutory Auditor is
currently being finalized.
Next financial event: Ordinary General Meeting on 26 June
2024
About Oncodesign Precision Medicine (OPM)
Oncodesign Precision Medicine (OPM), the result of the transfer
of Oncodesign's Biotech and AI activities, is a biopharmaceutical
company specializing in precision medicine to treat resistant and
metastatic cancers.
OPM's innovative technologies are (i) OncoSNIPER for the
selection of therapeutic targets using artificial intelligence;
(ii) Nanocyclix® for the design and selection of macrocyclic small
molecule kinase inhibitors and (iii) Promethe for the design and
selection of radiolabeled biological molecules for systemic
radiotherapy.
From these technologies, OPM has built a portfolio of
therapeutic products. A first drug candidate based on the
Nanocyclix® technology entered the clinical phase in 2022, in
partnership with SERVIER (which exercised its option for an
exclusive worldwide license on the program) to treat Parkinson's
disease. OPM-101 is OPM's second candidate to enter the clinic, in
the treatment of chronic immuno-inflammatory diseases. Finally, OPM
is also collaborating with Servier to discover new therapeutic
targets for the treatment of pancreatic adenocarcinoma based on its
OncoSNIPER technology. In addition, OPM is seeking a partner for
Florepizol, a radiotracer specific for the mutated EGFR target,
which has successfully completed Phase I. Finally, OPM has a
significant portfolio of early-stage projects with Nanocyclix® and
Promethe in oncology. With this portfolio of molecules and
diversified therapeutic targets, OPM's mission is to discover
effective therapies to treat resistant and advanced cancers. Based
in Dijon, at the heart of the university and hospital cluster, OPM
has 25 employees.
More info at: oncodesign.com
Forward-looking statements
This document contains forward-looking statements and estimates
with respect to the financial condition, results of operations,
strategy, plans and future performance of the Company and the
market in which it operates. Some of these statements, forecasts
and estimates can be identified by the use of words such as,
without limitation, "believes", "anticipates", "expects",
"projects", "plans", "seeks", "estimates", "may", "will" and
"continue" and similar expressions. They include all matters that
are not historical facts. Such statements, forecasts and estimates
are based on various assumptions and assessments of known and
unknown risks, uncertainties and other factors, which were believed
to be reasonable when they were made but which may prove to be
incorrect. Actual events are difficult to predict and may depend on
factors beyond the Company's control.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240326592753/en/
OPM Karine Lignel Deputy General Manager Tel: +33 (0)3 80
78 41 93 investisseurs@oncodesign.com
NewCap Investor Relations Mathilde Bohin / Alban Dufumier
Tel: +33 (0)1 44 71 94 95 oncodesign@newcap.eu
NewCap Media Relations Arthur Rouillé Tel: +33 (0)1 44 71
00 15 oncodesign@newcap.eu
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