- Cash position of €10.2 million as of March 31, 2024, includes
proceeds from the March 2024 financing1, featuring:
- €2 million invested by three members of management and Vester
Finance, the Company’s second-largest shareholder after the Soula
family
- An equity financing line (“PACEO2”) with Vester Finance for a
maximum of 1.7 million shares, the full utilization of which would
extend the Company’s cash runway into Q3 2025
- Continued partnership discussions with Sanofi on M1Pram and
preparations for the phase 2b trial in the United States
Regulatory News:
Adocia (Euronext Paris: FR0011184241 – ADOC), 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 first quarter of
2024 and provides a business update.
“We continue to pursue our priority of concluding a partnership
with Sanofi on M1Pram as soon as possible”, declared Olivier Soula,
CEO of Adocia. “At the same time, we are pleased to have extended
our cash runway, enabling us to execute our plans for our other
programs in cell therapy and obesity”.
First quarter 2024 financial results Financial highlights
for the quarter include the following:
Detail of the revenue
In thousands of euros, IFRS
standards (unaudited)
03/31/2024 (3 months)
03/31/2023 (3 months)
Licensing revenues
-
109
Research and collaboration
agreements
-
703
Revenue
-
812
First quarter 2023 revenues were primarily due to Adocia's work
under its collaboration with Tonghua Dongbao on the BioChaperone®
Combo (BC Combo) project to conduct three clinical studies in
Europe. These studies, the results of which were positive, were
completed in 2023 and therefore did not generate any revenue in Q1
2024.
Net Cash Position
The Company’s cash position was €10.2 million as of March 31,
2024, compared with €13.0 million as of December 31, 2023. This
includes €3 million received in March 2024 as part of the €2
million private placement fundraising and €1 million advance on the
equity financing line with Vester Finance. Cash used to fund
operations during the first quarter of 2024 was €5.8 million,
compared with €7.8 million in the prior-year quarter.
Net debt (excluding IFRS 16 impacts) was €5.7 million as of
March 31, 2024, unchanged from December 31, 2023. Debt consists of
State-Guaranteed Loan (PGE). Under the August 2023 renegotiated
repayment schedule, the next payment will be in the third quarter
of 2024.
The Company cash position of €10.2 million as of March 31, 2024,
is sufficient to finance currently planned operations through the
third quarter of 2025, excluding any income from existing or future
partnerships, but assuming the full utilization of the equity
financing line (“PACEO”) signed in March 2024 with Vester Finance
.
Adocia remains in exclusive negotiations with Sanofi for a
global partnership on M1Pram and is expecting two milestone
payments of $10 million each that are linked to progress with its
BioChaperone® Lispro and BioChaperone® Combo projects with Tonghua
Dongbao.
First quarter 2024 Highlights
M1Pram
Following the July 2023 agreement between Sanofi and Adocia,
negotiations are continuing with the goal of structuring a global
partnership.
M1Pram is a fixed-dose combination of insulin and amylin
analogues designed to address the unmet medical need of obesity in
people with type 1 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 with the finalization of production
of the first clinical batch. The study is expected to begin in the
third quarter of 2024.
BioChaperone® in partnership with Tonghua Dongbao
BioChaperone® Lispro
The two phase 3 studies with BioChaperone® Lispro are
progressing on schedule. Led by partner Tonghua Dongbao in China,
the program is enrolling 1,500 people with type 1 or type 2
diabetes. The last patient last visit, currently expected for the
second half of 2024, will trigger a payment of $10 million (out of
a maximum of $30 million in future milestone payments, followed by
royalties on net product sales).
BioChaperone® Combo
Tonghua Dongbao is actively preparing the next clinical studies
for BioChaperone® Combo and expects to submit the program for
approval by the CDE, the Chinese regulatory authority. The
treatment of the first patient in the first phase 3 study of
BioChaperone® Combo, which is expected in the second half of 2024,
will trigger a payment of $10 million (out of a maximum of $50
million in future milestone payments, followed by royalties on net
product sales).
AdoShell® Islets
The AdoShell platform, an immunoprotective biomaterial for cell
therapy, is attracting interest from potential pharmaceutical
partners.
The latest preclinical results were the subject of an oral
presentation at the Société Francophone du Diabète (SFD) congress
in March 2024 by Dr. Rosy Eloy, Chief Medical Officer of Adocia.
Additional data will be presented at the 84th Scientific Sessions
of the American Diabetes Association (ADA) in June 2024 in a
presentation titled: "AdoShell®, a non-fibrotic encapsulation
system for human islets transplantation shows promising results for
clinical application as a cure for people with type 1
diabetes".
Adocia is preparing to validate the proposed clinical
development plan with regulatory authorities. AdoShell® Islets
could be in clinical trials as early as 2025.
AdOral®
Adocia has developed a technology for the oral delivery of
peptides that is expected to allow for the switch from injectable
to oral form. An initial application to semaglutide (GLP-1) has
validated this technology in preclinical trials.
The AdOral® technology is currently being tested on peptides
from two pharmaceutical partners, and encouraging results obtained
to date are the basis for discussions to determine next steps in
these collaborations.
AdoGel®
Designed for the long-acting delivery of peptides, AdoGel® is
currently being tested on semaglutide (GLP-1). Preclinical results
will be presented at the ADA (American Diabetes Association)
Scientific Sessions in a presentation titled: "Development of a
once-a-month formulation of semaglutide from an innovative
injectable and biodegradable hydrogel".
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 See Company press release dated March 21, 2024.
2 PACEO: Programme d'Augmentation de Capital par Exercice
d'Options
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240514137379/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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