ADOCIA Announces Full Year 2023 Financial Results and Provides a Corporate and Financial Update
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Cash of €13.0m (million) as of
December 31, 2023 (€17.4m as ofDecember 31, 2022 ), including:- The signing of an exclusivity agreement with Sanofi on M1Pram and payment of €10m
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The
July 2023 €10m financing operation -
The contract termination with
IPF Partners , resulting in the repayment of all IPF debt (€10.2m) and the receipt of €2.5m from the exercise of its warrants
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Cash position subsequently bolstered by
March 2024 financing operation, consisting of a €2m private placement and a financing line with Vester Finance. The full utilization of the latter could extend the cash runway to Q3 2025 -
Advances with our flagship products and interest from potential partners:
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Continuation of partnership discussions with Sanofi on M1Pram and preparation for phase 2b study in
the United States - Preparation of the first clinical study and partnership discussions on AdoShell® technology
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Progress of the BioChaperone® Lispro phase 3 program and discussions between the Chinese regulatory authorities and partner Tonghua Dongbao on the next clinical steps for BioChaperone® Combo in
China
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Continuation of partnership discussions with Sanofi on M1Pram and preparation for phase 2b study in
Valérie Danaguezian,
"We are in an excellent position to create value for our shareholders, with a mature partnership in
Financial highlights
The following table summarizes the financial statements under IFRS for the year ended
In (€) thousands, Consolidated financial statements |
FY 2023
|
FY 2022
|
Revenue |
2 150 |
11 447 |
Grants, Research tax credit, others |
3 899 |
5 914 |
Operating revenue |
6 048 |
17 361 |
Research and development expenses |
(14 813) |
(25 898) |
General and administrative expenses |
(5 479) |
(4 359) |
Operating expenses |
(20 293) |
(30 257) |
OPERATING INCOME (LOSS) |
(14 244) |
(12 896) |
Other operating revenue and expenses |
0 |
11 199 |
OPERATING INCOME |
(14 244) |
(1 698) |
FINANCIAL INCOME (LOSS) |
(6 916) |
(4 727) |
Tax |
(2) |
(476) |
NET INCOME (LOSS) |
(21 162) |
(6 901) |
The Company's results for 2023 are characterized by:
A net loss of €21.2m (million) in 2023, compared with a loss of €6.9m in 2022, mainly due to:
- Revenue of €2.2m in 2023 (compared with €11.4m in 2022), including €1.5m from activities with Tonghua Dongbao (THDB) on BioChaperone® (BC) Combo and €0.6m from a feasibility study on the AdOral® project.
By way of comparison, 2022 sales of €11.4m included (i) services performed for THDB on BC Combo, and (ii) a €4.8m milestone payment received in
- Other operating income of €3.9m, comprising (i) the Research Tax Credit (CIR) of €3.4m generated on expenses for the 2023 financial year, down from the 2022 CIR (€5.9m) reflecting the drop in eligible operating expenses, and (ii) the €0.5m
- Operating expenses of €20.3m, a reduction of €10m compared with 2022. This reflects lower R&D expenses, partly offset by higher overheads.
- The €11m decrease in research and development expenses is mainly due to lower clinical expenditures. In 2022, this item was impacted by expenses related to the three clinical trials, which ended in 2023, carried out as part of the partnership with THDB on BC Combo. The year 2023 was also marked by a close monitoring of headcounts and expenses in a tight financial context.
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The €1.1m increase in overheads compared with 2022 is mainly due to legal and consulting expenses incurred in connection with (i) the restructuring of
IPF Partners debt, and to a lesser extent, (ii) the financing transactions carried out.
- Negative financial income of €6.9m is mainly due to (i) interest paid on the state guaranteed loan (PGE) and on the loan taken out with
- The net loss for 2023 of €21.2m declined versus 2022 (loss of €6.9m). This decrease is mainly due to the positive effect in 2022 of the sale-leaseback transaction on the head office, which generated income of €11.2m.
- For the record, a non-current operating income of €11.2m was recognized in 2022 following the sale-leaseback of the head office in
A cash position of €13.0m as of
The cash position at year-end 2023 reflects the following main receipts and disbursements, mainly in the second half of 2023:
- Payment in
- €10m financing package consisting of a €5m private placement and a €5m convertible bond issue. All the convertible bonds issued by the Company were converted at the end of
- Repayment of €10.2m debt to
- Receipt of €2.5m from the exercise of all
Cash used in operating activities for 2023 was €14.9m, lower than last year (€19.5m), on a comparable basis (excluding financing operations).
Debt (excluding IFRS16 impacts and derivatives) of €5.7m as of
This significant reduction is mainly due to (i) the repayment of the
Cash runway and outlook
As of
On
With a €3m cash injection received on the signing of this transaction, the company's cash runway has been extended to
In addition,
Lastly, the Company still considers accessing the financial markets to finance its research.
Highlights of the year 2023
Product pipeline
The year 2023 was marked by progress with our flagship products, notably M1Pram and AdoShell® Islets, which attracted the interest of potential partners with a view to establishing licensing agreements. At the same time,
Major clinical advances and the deployment of technological platforms
- M1Pram: towards a global partnership to meet a major unmet medical need
This fixed combination of insulin analogues and amylin is intended to provide a solution to the problem of obesity in people with type 1 diabetes or insulin-dependent type 2 diabetes. In
On
On the clinical development front, the
- AdoShell® Islets: a strategic priority
In 2023, new data on AdoShell® Islets, an immunoprotective biomaterial containing islets for the treatment of diabetes by cell therapy, were communicated at the prestigious CTRMS international congresses of
Discussions are underway to establish a partnership for the technology.
- BioChaperone® Combo: three positive clinical studies
Positive results from three clinical studies conducted on BioChaperone® Combo (CT046 - 47 and 48) were announced in 2023. Conducted by
The various clinical studies conducted confirm the potential of BioChaperone® Combo to reduce postprandial hyperglycemia and the risk of hypoglycemia compared with the reference premix insulin Humalog® Mix, while ensuring basal control over 24 hours. The data generated support the objective of effective dosing in one or two doses per day. The overall evaluation showed that BioChaperone® Combo has a good benefit/risk ratio, supporting its clinical development in the next phase.
Tonghua Dongbao is currently discussing the next development steps with the Chinese regulatory authorities. Treatment of the first BC Combo phase 3 patient, expected in 2024, will trigger a
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BioChaperone® Lispro: phase 3 progresses in
China
The extensive phase 3 program for BioChaperone® Lispro initiated in 2022 is currently underway. Led by partner Tonghua Dongbao, the program involves 1,300 people with type 1 or type 2 diabetes in over 100 clinical research centers in
Preparatory work for phase 3 trials in
New proprietary technology platforms to improve peptide delivery
- AdOral®: oral delivery of peptides to replace injections
The AdOral® technology is currently being studied on peptides from two pharmaceutical partners, and discussions are underway to determine the next steps in these collaborations.
- AdoGel®: long-acting peptide delivery to reduce the number of injections
AdoGel®has been designed to enable long-term delivery of GLP-1, to reduce the number of annual administrations from 52 to 12, and to reduce the production of auto-injectors. Designed for monthly release, AdoGel®Sema avoids an initial concentration peak and ensures semaglutide release with a pseudo-zero order profile in animals.
Changes in governance
In
Post-period events
In
2024 Milestones
- BioChaperone® Lispro: end of phase 3 in
- BioChaperone® Combo: Start of the next clinical trials currently under discussion between Tonghua Dongbao and the Chinese regulatory authorities.
- M1Pram: start of phase 2b in the
- AdoShell® Islets: preparation of regulatory interactions for first-in-human study.
- Continued deployment of the AdoGel® and AdOral® technology platforms.
About
The company has a broad portfolio of drug candidates based on four proprietary technology platforms: 1) The BioChaperone® technology for the development of new generation insulins and products combining insulins with other classes of hormones; 2) AdOral®, an oral peptide delivery technology; 3) AdoShell®, an immunoprotective biomaterial for cell transplantation, with an initial application in pancreatic cells transplantation; and 4) AdoGel®, a long-acting drug delivery platform.
Disclaimer
This press release contains certain forward-looking statements concerning
The forward-looking statements contained in this press release are also subject to risks not yet known to
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1
Conway B, Miller RG, Costacou T, Fried L, Kelsey S, Evans RW, Orchard TJ. Temporal patterns in overweight and obesity in Type 1 diabetes. Diabet Med. 2010. Apr;27(4):398-404. doi: 10.1111/j.1464-5491.2010.02956.x. PMID: 20536510; PMCID: PMC3129711.
2Epidemiology of Obesity and Diabetes and Their Cardiovascular Complications
3 Press Release,
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CEO
contactinvestisseurs@adocia.com
+33 (0)4 72 610 610
www.adocia.com
Ulysse Communication
adocia@ulysse-communication.com
+ 33 (0)6 87 88 47 26
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