- Cash position of €10.3 million as of June 30, 2024
- Continuation of partnership discussions on M1Pram with
Sanofi
- BioChaperone® Lispro Phase 3 study is on track for completion
in December, milestone associated with a payment of $10
million
- Post-period events:
- Cash position increased to nearly €13 million as of today, with
the receipt of €3.4 million from the reimbursement of the 2023
Research tax credit
- Termination of the BioChaperone® Combo program by Tonghua
Dongbao for strategic reasons
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 second quarter of 2024 and provides a business update.
"I am confident about signing future partnerships because our
product portfolio fully aligns with the rapidly growing markets of
obesity and diabetes cell therapy," declares Olivier Soula, CEO of
Adocia. "After M1Pram, our technologies AdoGel, AdOral, and
BioChaperone, perfectly address the formulation challenges of new
obesity molecules: reducing the number of injections or even
eliminating them, and combining hormones to improve the
effectiveness and quality of weight loss."
"In a challenging financial environment for Biotechs, Adocia
managed to maintain its cash position at close to €13 million as of
July 24, 2024, allowing us to carry out all the activities defined
in our ambitious operational plan," added Valérie Danaguezian,
Chief Financial Officer of Adocia. "Indeed, the PACEO entrusted to
Vester Finance, Adocia's second-largest shareholder, has worked as
anticipated with €6 million raised to date, at an average share
price of €8 and controlled dilution of 5%. The conditions set by
the PACEO offer great flexibility in its management, but we are
prioritizing the signing of partnerships.”
Second quarter 2024 financial results
Financial highlights for the quarter include the following:
DETAIL OF THE REVENUE
In thousands of euros, IFRS
standards (unaudited)
06/30/2024 (3 months)
06/30/2023 (3 months)
06/30/2024 (6 months)
06/30/2023 (6 months)
Licensing revenues
0
52
0
161
Research and collaboration
agreements
0
763
0
1 466
Revenue
0
815
0
1 627
Adocia did not recognize any sales in the first half of
2024.
Last year, over the same period, sales of €1.6 million reflected
revenues linked to the ongoing feasibility study on AdOral® as well
as services provided by Adocia as part of the collaboration signed
with Tonghua Dongbao for the conduct of three clinical studies in
Europe on the BioChaperone® Combo project.
Net Cash Position
The Company's cash position stood at €10.3 million as of June
30, 2024, compared with €13.0 million as of December 31, 2023. This
position includes €2 million received from the private placement in
March 2024, and €5.9 million from the use of the PACEO (via the
issuance of 745,000 shares out of the maximum 1.7 million shares
set in the contract).
Cash used to fund operations during the first half of 2024
amounted to €10.6 million, similar to last year's figure for the
same period and at comparable basis (restated for the receipt of
the Research Tax Credit).
Net debt (excluding IFRS 16 impacts) was €5.7 million as of June
30, 2024, unchanged from December 31, 2023. Debt consists of
State-Guaranteed Loan (PGE), the next repayments of which will take
place from the third quarter of 2024, with a maturity date of
August 2026.
The Company cash position of €10.3 million as of June 30, 2024,
is sufficient to finance the currently planned operations through
the third quarter of 2025, excluding any potential income from
existing or future partnerships, but assuming the full utilization
of the equity financing line (“PACEO”) signed in March 2024 with
Vester Finance1.
Adocia remains in exclusive negotiations with Sanofi for a
global partnership on M1Pram, and is expecting a milestone payment
of €10 million linked to progress of its BioChaperone® Lispro
project in partnership with Tonghua Dongbao.
Post-period highlight
On July 10, 2024, Adocia received the full amount of its
Research Tax Credit (CIR) due for 2023, amounting to €3.4 million.
This brings Adocia's cash position as of July 24, 2024 to nearly
€13 million.
Second quarter 2024 Highlights
Strengthening management
Mathieu-William Gilbert has been appointed Chief Operating
Officer. He previously held Vice President and General Management
positions at Novo Nordisk. He will strengthen Adocia's management
team as part of the company's strategic transformation project. He
will oversee Adocia's operations and help to accelerate its
development and growth.
M1Pram
Following the July 2023 agreement between Sanofi and Adocia,
negotiations are continuing to structure a global partnership. The
exclusivity agreement is still in force. M1Pram is a fixed-dose
combination of insulin and amylin analogues designed to address the
unmet medical need of obesity in people with insulin-dependent
diabetes. Preparations for the phase 2b clinical program in the
United States, which will enroll 140 patients with type 1 diabetes
and a BMI >30kg/m², are continuing.
BioChaperone® Lispro - in partnership with Tonghua
Dongbao
The pipeline review carried out by Tonghua Dongbao confirmed the
important place occupied by BioChaperone® Lispro. The phase 3
program, led in China on 1,500 people with type 1 or type 2
diabetes, is on track, with the last patient last visit (LPLV)
currently expected for the second half of 2024. The successful
achievement of this important milestone will trigger a payment of
$10 million to the Company. The license agreement also provides for
an additional $20 million payment triggered by the regulatory
approval of BioChaperone® Lispro, as well as double-digit royalties
on net product sales.
AdoShell® Islets
The AdoShell platform, an immunoprotective biomaterial for cell
therapy, is attracting interest from potential pharmaceutical
partners, with whom discussions are ongoing. Over the second
quarter of 2024, the teams attended several international
congresses to share preclinical data: the American Diabetes
Association (ADA) in Orlando, and the European Islet Study Group
2024 (EISG) in Helsinki. The AdoShell® program has also been
selected for an oral presentation at the European Association for
the Study of Diabetes (EASD) to be held on September 9-13 in
Madrid. Adocia is working with the regulatory authorities to
validate the first clinical trial, which could take place as early
as 2025.
AdOral®
Adocia has developed an oral peptide delivery technology, making
it possible to switch from injectable to oral forms. This program
was also highlighted at the American Diabetes Association (ADA)
meeting for its application to semaglutide (GLP-1). The only GLP-1
currently marketed in oral form, Rybelsus®, achieved sales of 2.7
billion in 20232. Oral delivery is a key factor in increasing
patient adherence to these treatments, for both diabetes and
obesity. The AdOral® technology is currently being tested on
peptides from two pharmaceutical partners. The encouraging results
obtained are enabling discussions to move forward to determine the
next steps in these collaborations.
AdoGel®
Designed for the long-acting delivery of peptides, AdoGel® is
currently being studied on semaglutide (GLP-1). GLP-1s, which
generated sales of over $37 billion in 20233, are almost
exclusively formulated as weekly injections. AdoGel®'s unique
technology makes it possible to envisage monthly or even quarterly
injections. Promising pre-clinical results were presented at the
American Diabetes Association (ADA) congress in June and the
Controlled Release Society (CRS) congress in July in Bologna.
Post-period event
BioChaperone® Combo
On July 10, 20244, Tonghua Dongbao announced its decision to
terminate the BioChaperone® Combo program after re-evaluating its
R&D projects and considering recent changes in the regulatory
and competitive environment. Adocia thus regains full ownership, at
no cost, of the rights to BioChaperone® Combo, which had
demonstrated positive results in three clinical trials (CT046,
CT047, CT048)5.
The $40 million received upon signature of the license agreement
on April 26, 2018 is vested and non-refundable. Tonghua Dongbao and
Adocia teams are currently working on the operational and legal
closing of the file.
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, 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 Calculated on the basis of a theoretical share price of
7€, corresponding to the average Adocia share price over the last
30 days, applied to all the shares remaining in the PACEO. 2
Source: Global Data, based on Novo Nordisk’s consolidated sales
3 Source: Global Data, based on consolidated sales 4
Press Release, July 10, 2024, ADOCIA Announces that Tonghua Dongbao
is Discontinuing one of the two Partnership Programs: BioChaperone
Combo 5 Press Release, October 23, 2023, ADOCIA’s Partner
Tonghua Dongbao Announces Positive Results of Three Clinical Trials
on BioChaperoneCombo
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240724573234/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
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