- Cash position of €9.3 million as of September 30, 2024
- Completion of the Phase 3 study on BioChaperone® Lispro
expected in December 2024, associated with a $10 million payment by
Tonghua Dongbao
- Development of a stable combination of cagrilintide and
semaglutide (CagriSema) using the BioChaperone® platform
- Ongoing partnership discussions on M1Pram with Sanofi
Regulatory News:
Adocia (Euronext Paris: FR0011184241 – ADOC, the “Company”), a
clinical-stage biopharmaceutical company focused on the research
and development of innovative therapeutic solutions for the
treatment of diabetes and obesity, reports financial results for
the third quarter of 2024 and provides a business update.
"Beyond M1Pram and the other projects we are developing, we are
very excited to have found a unique solution for the formulation of
CagriSema, which could be a major element in the treatment of
obesity in the future", says Olivier Soula, CEO of Adocia.
"We are maintaining our cash runway until the third quarter of
2025 thanks to rigorous management, focused on our strategic
projects. The PACEO, established in March 2024, is a controlled
financing solution pending revenues from BioChaperone Lispro and
the conclusion of other partnerships that could generate
significant income", adds Mathieu-William Gilbert, COO-CFO of
Adocia.
Third quarter 2024 financial results
Financial highlights for the quarter include the following:
Detail of the revenue
In thousands of euros, IFRS
standards (unaudited)
09/30/2024
09/30/2023
09/30/2024
09/30/2023
(3 months)
(3 months)
(9 months)
(9 months)
Licensing revenues
0
77
0
238
Research and collaboration
agreements
0
243
0
1 709
Revenue
0
320
0
1 947
Adocia has not recognized any revenue since the beginning of the
year.
Last year, over the same period, the revenue of €1.9 million
reflected revenues related to the ongoing feasibility studies on
AdOral®, as well as services provided by Adocia under the
collaboration with Tonghua Dongbao for conducting three clinical
studies in Europe on the BioChaperone® Combo project.
Net Cash Position
The Company's cash position stood at €9.3 million as of
September 30, 2024, compared to €13.0 million as of December 31,
2023. This position includes €2 million received from the private
placement in March 2024 and €7.0 million from the use of the equity
financing line signed in March 2024 with Vester Finance in the form
of a PACEO1 (via the issuance of 945,000 shares out of a maximum of
1.7 million shares set in the contract).
The cash burn related to activities for the first nine
months of 2024 amounted to €12.6 million, compared to €10.8 million
during the same period last year on a comparable basis (excluding
financing). Adjusted for the impact of the Research Tax Credit
(CIR), cash burn amounted to €16 million, down slightly by €0.7
million compared to the same period last year.
Net financial debt (excluding IFRS 16 impacts),
consisting exclusively of state-guaranteed loans (PGE), amounted to
€5.2 million as of September 30, 2024, down €0.5 million compared
to June 30, 2024, following the resumption of repayments of the PGE
in August 2024, with the loans’ maturity remaining unchanged at the
end of August 2026.
The cash position as of September 30, 2024, of €9.3
million allows the Company to fund its activities until the third
quarter of 2025, without considering potential revenues generated
by existing or future partnerships but taking into account the full
utilization of PACEO signed in March 2024 with Vester Finance2.
Adocia is still in exclusive negotiations with Sanofi for a
global partnership on M1Pram, as well as other products. In
addition, the Company expects a milestone payment of $10 million
related to the progress of the BioChaperone® Lispro project in
partnership with Tonghua Dongbao.
Third quarter 2024 Highlights
BioChaperone® GLP-1 – Amylin
In a context where the obesity and diabetes markets are booming,
pharmaceutical companies are striving to differentiate themselves
with more effective, better-tolerated, simpler-to-use, or
easier-to-produce products to meet the unmet demand. One approach
is to combine different metabolic hormones, which are sometimes
incompatible. Adocia, thanks to its historical BioChaperone®
platform, has achieved this technical feat. Stable formulations of
amylin and GLP-1 analogs, including cagrilintide and semaglutide
("CagriSema"), have been developed, and new patents have been
filed. These combinations allow administration via standard
injection devices, including multi-use ones, which would increase
the number of patients treated at a constant industrial capacity
for pharmaceutical companies. These patents, offering protection
until 2045, should position Adocia as a potential partner for
pharmaceutical players working on hormone combinations.
M1Pram
M1Pram is a fixed combination of insulin and amylin analogs
aimed at addressing the unmet medical need of obesity in
insulin-dependent individuals.
A phase 2b clinical program in the United States, involving 140
patients with type 1 diabetes and a BMI>30kg/m², is in
preparation. Adocia has completed the production of clinical
batches. The launch of this program will be conditional on the
signing of an agreement regarding the product.
Following the exclusivity agreement signed between Sanofi and
Adocia3, which remains in effect to date, discussions regarding a
potential global partnership remain ongoing.
AdoShell® Islets
The AdoShell® platform, an immunoprotective biomaterial for cell
therapy, is attracting interest from potential pharmaceutical
partners with whom discussions are ongoing. In the third quarter of
2024, Adocia's teams presented exclusive data at the European
Association for the Study of Diabetes (EASD) in Madrid. These
presentations highlighted the translational work towards a clinical
object and implantation trials in large animals, conducted in
collaboration with Professor Pattou from the Lille University
Hospital, as well as in vivo demonstrations of AdoShell®
compatibility with islets derived from stem cells.
Adocia has had an initial interaction with French regulatory
authorities to prepare for the human study, scheduled for 2025.
BioChaperone® Lispro - partnership with Tonghua
Dongbao
The phase 3 program, conducted in China with 1,500 people with
type 1 or type 2 diabetes, is proceeding according to plan. The
last patient last visit (LPLV) is expected in December 2024. The
license agreement between the Company and Tonghua Dongbao provides
that this milestone will trigger a $10 million payment process.
This agreement also includes the payment of an additional $20
million upon the first marketing authorization for BioChaperone®
Lispro, as well as double-digit royalties on sales.
BioChaperone® Combo
On July 10, 2024, Tonghua Dongbao announced its decision to
discontinue the BioChaperone® Combo program after reassessing its
R&D projects and considering recent changes in the regulatory
and competitive environment4. As a result, Adocia regained full
ownership of the rights to BioChaperone® Combo at no cost. The
program had demonstrated positive results in three clinical trials
(CT046, CT047, CT048)5. The $40 million received at the signing of
the license agreement on April 26, 2018, is non-refundable.
AdOral®
Adocia has developed an oral delivery technology for peptides,
enabling the transition from injectable to oral forms, and has
achieved promising preclinical results on semaglutide (GLP-1). The
only GLP-1 commercially available in oral form to date, Rybelsus®,
achieved $2.7 billion in global sales in 20236. Oral delivery is a
key factor in increasing patient adherence for those with diabetes
and/or obesity. The AdOral® technology has been tested on peptides
from two pharmaceutical partners and has shown encouraging results.
Discussions are currently ongoing.
AdoGel®
Designed to enable long-term peptide delivery, AdoGel® is
currently being studied on semaglutide (GLP-1). GLP-1, a market
that generated over $37 billion in global revenue in 2023, is
almost exclusively formulated for weekly injections7. AdoGel®'s
unique technology could enable monthly or even quarterly
injections. Promising preclinical results were presented this
quarter at the Controlled Release Society (CRS) conference in July
in Bologna and at the European Association for the Study of
Diabetes (EASD) in September in Madrid, where the importance of
long-acting formulations was highlighted.
Governance
On September 23, 2024, Mathieu-William Gilbert was appointed
Chief Financial Officer (CFO). These new responsibilities are in
addition to his role as Chief Operating Officer (COO), which he has
held since May 2024. He joined Adocia following a distinguished
career of over fifteen years at Novo Nordisk, where he held Vice
President and General Manager positions for several subsidiaries.
He strengthens Adocia's leadership team as part of the Company's
strategic transformation project. He oversees Adocia's operations,
administrative and financial functions, investor relations, legal
affairs, and human resources. He is also a member of the Executive
Committee and serves as the General Secretary of the Board of
Directors.
Valérie Danaguezian, who had held the position of CFO since
Adocia's founding in 2005, left the company to focus on a family
project.
The Board of Directors, which met on September 18, 2024,
acknowledged the end of Claudia Mitchell's term and Katherine
Bowdish's resignation as independent directors. To replace
Katherine Bowdish, the Board co-opted Valérie Moumdjian as an
independent director and appointed her to the Audit Committee and
the Compensation Committee. Her co-option as a director will be
submitted for ratification by shareholders at the next Adocia
Annual General Meeting. The Board of Directors now consists of six
members, four men and two women, with four independent directors
among them.
About Adocia
Adocia is a biotechnology company specializing in the discovery
and development of therapeutic solutions in the field of metabolic
diseases, primarily diabetes and obesity.
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 different 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.
Adocia holds more than 25 patent families. Based in Lyon, the
company has about 80 employees. Adocia is listed on the regulated
market of Euronext™ Paris (Euronext: ADOC; ISIN: FR0011184241).
Disclaimer
This press release contains certain forward-looking statements
concerning Adocia and its business. Such forward-looking statements
are based on assumptions that Adocia considers as being reasonable.
However, there can be no guarantee that the estimates contained in
such forward-looking statements will be achieved, as such estimates
are subject to numerous risks including those set forth in the
“Risk Factors” section of the universal registration document that
was filed with the French Autorité des marchés financiers on April
29, 2024, as updated in the Company’s 2024 Half-year financial
statements, published on September 19, 2024, both available at
www.adocia.com. Those risks include uncertainties inherent in
Adocia's short- or medium-term working capital requirements, in
research and development, future clinical data, analyses and the
evolution of economic conditions, the financial markets and the
markets in which Adocia operates, which could impact the Company's
short-term financing requirements and its ability to raise
additional funds.
The forward-looking statements contained in this press release
are also subject to risks not yet known to Adocia or not considered
as material by Adocia at this time. The occurrence of all or part
of such risks could cause the actual results, financial conditions,
performances, or achievements of Adocia be materially different
from those mentioned in the forward-looking statements.
_________________________________ 1 For further details on this
financing line, please refer to the Company's press release dated
March 21, 2024. 2 Calculated on the basis of a theoretical share
price of €7 applied to all remaining shares under the equity
financing line (see Adocia’s press release dated July 24, 2024). 3
Press Release, July 5, 2023, ADOCIA Grants Sanofi an Exclusive
Right to Negotiate a Partnership on M1Pram for 10 Million Euros and
Obtains Commitment from Investors to Provide 10 Million Euros in
Financing 4 PR, July 10, 2024, ADOCIA Announces that Tonghua
Dongbao is Discontinuing one of the two Partnership Programs:
BioChaperone® Combo 5 PR, October 23, 2023, ADOCIA’s Partner
Tonghua Dongbao Announces Positive Results of Three Clinical Trials
on BioChaperone® Combo 6 Source: Global Data, based on consolidated
sales 7 Source: Global Data, based on consolidated sales
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241030571966/en/
Adocia Olivier Soula CEO
contactinvestisseurs@adocia.com +33 (0)4 72 610 610
www.adocia.com
Ulysse Communication Adocia Press & Investor
Relations Bruno Arabian Nicolas Entz
adocia@ulysse-communication.com + 33 (0)6 87 88 47 26
Adocia (EU:ADOC)
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