ADOCIA Reports Fourth Quarter 2023 Financial Results and Provides a Business Update
-
Cash of €13.0 million as of
December 31, 2023 , with cash burn of €3.8 million in Q4 2023 - Indebtedness reduced to a €5.6 million state-guaranteed loan
-
Continued discussions with Sanofi on M1Pram and progress in development with the manufacturing of clinical batches for Phase 2b in
the United States - Consolidated preclinical efficacy data on AdoShell® Islets in preparation for first-in-human study, and interest expressed by major pharmaceutical companies in in-licensing the technology
- Positive results on three BioChaperone® Combo clinical trials enabled Adocia’s partner Tonghua Dongbao to prepare next development steps with Chinese regulatory authorities
Adocia’s management will hold a web conference at
“We are emerging from an eventful 2023 as a strengthened company and we enter 2024 with active discussions underway with Sanofi on M1Pram, and also with key players on AdoShell Islets”, said
Fourth quarter 2023 financial results
"During the fourth quarter 2023, we maintained focus on advancing M1Pram and AdoShell Islets, as well as developing BC Lispro and BC Combo in support of our Chinese partner.
Full year audited financial results for 2023 will be published in
The main financial figures for the quarter are as follows:
Detail of the revenue
In thousands of euros, IFRS standards (unaudited) |
|
|
|
|
Licensing revenues |
75 |
88 |
313 |
5 088 |
Research and collaboration agreements |
128 |
1 608 |
1 837 |
6 359 |
Revenue |
203 |
1 696 |
2 150 |
11 447 |
The Company’s revenues are mainly derived from the licensing and collaboration agreements signed with Tonghua Dongbao (THDB) for the development, manufacturing and marketing of BioChaperone® (BC) Lispro and BioChaperone® Combo in
Revenue for the fourth quarter of 2023 of €0.2 million consists of services provided by Adocia’s teams on BC Combo and the completion of three clinical trials in
Annual revenues for 2023 of €2.2 million consists of €1.5 million from THDB related to BC Combo activities and €0.6 million from an ongoing feasibility study on the AdOral® project.
For comparison, revenue in 2022 of €11.5 million represented (i) services performed for THDB on BC Combo, and (ii) a €4.8 million milestone payment received in
Finally, and marginally now, 2023 licensing revenue included the impact of the application of IFRS 15 on the treatment of the upfront payment received from THDB in 2018, upon signature of the licensing agreements. This represents an amount of €238,000 in 2023, compared with €262,000 in 2022. Amortization was complete as of the end of
Net Cash Position
The company’s cash position stood at €13.0 million as of
-
Sanofi’s payment of €10 million in
July 2023 under the M1Pram exclusivity agreement; -
The completion of a €10 million financing consisting of a €5 million private placement and the issuance of €5 million in convertible bonds. All convertible bonds issued by the company have been converted as of the end of
September 2023 , and Vester Finance declared that it had exceeded the threshold of 10% of the Company’s capital, positioning itself as a significant shareholder in the Company; -
Repayment of
IPF Partners debt in the amount of €10.2 million; -
The receipt of €2.5 million following the full exercise of
IPF Partners warrants.
Cash outflows from operating activities for 2023 were €14.5 million, down from last year’s outflow of €23 million (with both periods excluding financing operations).
Net financial debt (excluding IFRS 16 impacts and derivative instruments) was €5.7 million as of
4th Quarter Highlights
M1PRAM: toward a global partnership to address a serious unmet medical need
As a reminder, on
In
- Clinical development
Manufacturing of clinical batches is underway, to ensure the launch of the Phase 2b study during the third quarter of 2024.
- Medical need
In
ADOSHELL® ISLETS: a strategic priority
New data on AdoShell® Islets, an immunoprotective biomaterial containing islets for the treatment of diabetes by cell therapy, were revealed at the prestigious international congresses of the
The data support AdoShell® Islets as a biocompatible immunoprotective material for islet transplantation, without immunosuppression. In vivo, in rodent diabetic models, the survival of encapsulated islets was maintained after a 7-month study without immunosuppression, and efficacy was established with the ability to control hyperglycemia. Designed for minimally invasive surgery, AdoShell® Islet has demonstrated exceptional biocompatibility.
The preclinical data generated to date are attracting the interest of major industry players, and discussions have been initiated.
The AdoShell® matrix, as a technological platform, is also being considered for applications with stem cells and in other therapeutic fields (e.g., Parkinson's disease, hemophilia, oncology, etc.). Deployment of the platform will depend on the interest of future partners.
BC COMBO & BC LISPRO: capitalizing on our strong partnership with THDB
- BioChaperone® Combo
Positive results from three clinical studies conducted with BC Combo (CT046 - 47 and 48) were announced in
The studies enrolled people with type 1 and type 2 diabetes, and healthy Chinese volunteers, and demonstrated BC Combo efficacy, with a good safety and tolerance profile.
The different clinical studies conducted confirm the potential of BC Combo to reduce postprandial hyperglycemia and lower the risk of hypoglycemia, while providing 24-hour basal control. The data generated support the goal of effective once- or twice-daily dosing.
The overall findings showed that BC Combo had a good benefit/risk ratio, supporting its clinical development in the next phase. Tonghua Dongbao is currently preparing the next stages of development with the Chinese regulatory authorities. Treatment of the first patient in the first Phase 3 of BC Combo, expected in 2024, would trigger a
- BioChaperone® Lispro
The pivotal Phase 3 program with BioChaperone Lispro, conducted in
ADORAL®: the promise of oral delivery of peptides
Aiming to overcome the challenge of oral peptide administration, AdOral is attracting the interest of several biopharmaceutical companies. The AdOral technology is currently being tested on peptides from two pharmaceutical partners.
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
1
Press Release,
2
3
View source version on businesswire.com: https://www.businesswire.com/news/home/20240227159759/en/
CEO
contactinvestisseurs@adocia.com
+33 (0)4 72 610 610
www.adocia.com
Ulysse Communication
adocia@ulysse-communication.com
+ 33 (0)6 64 79 97 51
Source: