- A cash position of 15.2 million euros on December 31, 2021,
strengthened to 28 million euros on March 28, 2022
- Major technical advances in 2021: - The approval to enter Phase
3 in China for BioChaperone® (BC) Lispro, granted by the Chinese
regulatory authorities (CDE) to our partner Tonghua Dongbao - The
start of two clinical studies on M1Pram and BC LisPram - 3 patents
on two new platforms: an immunoprotective hydrogel matrix for cell
therapy (AdoShell®) and an oral peptide delivery technology
(AdOral®)
- Promising perspectives for 2022: - Start of BC Lispro Phase 3
in China - Completion of clinical studies to support BC Combo's
Phase 3 dossier in China - Publication of M1Pram (Phase 2) and BC
LisPram (Phase 1) clinical studies results - Phase 1 studies
preparation on our new projects
Regulatory News:
Adocia (Euronext Paris: FR0011184241 – ADOC) (Paris:ADOC), a
clinical-stage biopharmaceutical company focused on the research
and development of innovative therapeutic solutions for the
treatment of diabetes and other metabolic diseases, announced today
its full year 2021 financial results as of December 31, 2021. The
financial statements were approved by the Board of Directors set on
April 14, 2022 and will be submitted for shareholder approval at
the next General Shareholders’ Meeting on June 28, 2022.
"We are very pleased with the advancement of our two projects,
BC Lispro and BC Combo, in Asia by our partner Tonghua Dongbao with
the enhanced prospect of receiving up to $85 million in milestone
payments over the coming years", said Gérard Soula, Chairman and
CEO of Adocia. "The preclinical results obtained in cell therapy
and oral delivery of peptides provide us with new partnership
opportunities in addition to those underway for BC Lispro, BC Combo
and multi-hormonal combinations.”
Financial highlights
The following table summarizes the financial statements under
IFRS for the years ended December 31, 2021 and December 31,
2020:
In (€) thousands, Consolidated
financial statements, IAS/IFRS
FY2021 (12 months)
FY 2020 (12 months)
Revenue
1 444
841
Grants, Research tax credit,
others
4 611
5 992
Operating revenue
6 055
6833
Research and development
expenses
(20 016)
(22 547)
General and administrative
expenses
(5 404)
(5 434)
Operating expenses
(25 421)
(27 981)
OPERATING INCOME
(LOSS)
(19 366)
(21 148)
FINANCIAL INCOME
(LOSS)
(3 388)
(2 147)
Tax
-
(29)
NET INCOME (LOSS)
(22 754)
(23 324)
Company's results for the year 2021 are characterized:
- Net loss of € 22.8 million in 2021, compared to a loss of €23.3
million in 2020, mainly consisted of:
- Revenue of €1.4 million in 2021 (compared to €0.8 million in
2020) coming essentially from the two-licensing contract signed
with Tonghua Dongbao. In 2021, additional services have been
performed by Adocia for a total amount of €1 million income at the
request of our Chinese partner for the preparation of 3 clinical
trials conducted in Europe on BC Combo;
- Other operating income of €4.6 million, resulting mainly from
the research tax credit (CIR) generated on 2021 expenses;
- Total operating expenses of €25.4 million, a €2.5 million
decrease compared to last year;
- Financial loss of €3.4 million reflecting the financial
interests paid on the €15 million IPF partner loan contracted in
2019. The increase of €1.1 million 2021 is mainly explained by the
IFRS impact (non-cash) of the revaluation at fair value through
income of the convertible bond contracted in October 2021.
- A cash position of €15.2 million as of December 31, 2021
(compared to €28.1 million as of December 31, 2020).
The cash consumption over the full year 2021 was €19.9 million,
in a decrease compared to 2020 (which was €22.5 million), on a
comparable basis (excluding financing operations).
Net financial debts (excluding the impact of derivative
instruments) amounted to €33.3 million the end of December 2021,
compared to €27.3 million twelve months earlier. The increase of €6
million is mainly due to the convertible bond financing completed
in October 2021, which resulted in a net cash in-flow of €6
million. A portion of the bonds was converted at the end of
December, the balance being recorded as debt under IFRS 9 and IAS
32.
In addition, in March 2022 the company has sold its headquarter
offices for a net amount of €19 million. Taking this into account
and the consumption of cash during the first quarter of 2022, the
company's cash position amounted to €28 million on March 28, 2022,
the day of the sale signature.
"We are pleased to have been able to complete the sale of our
building, which has significantly strengthened our cash position
without dilution for our shareholders and no impact on operations.
Our cash position at the end of March provides us with sufficient
financial resources to execute the announced news flow," said
Valérie Danaguezian, Chief Financial Officer of Adocia.
Key events in 2021
2021 was marked by major advances in our insulin portfolio and
by the achievement of important proofs of concept on new
technological platforms in cell therapy and oral delivery of
peptides. In addition, the financial operation carried out in the
last quarter strengthened the financial resources available to
support the Company's growth.
Significant progress made on mature
projects in our pipeline:
- BioChaperone® Lispro: approved to enter Phase 3 in China
In October 2021, Tonghua Dongbao received approval from the CDE
(Center for Drug Evaluation) to start the Phase 3 program of BC
Lispro ultra-rapid insulin for the treatment of type 1 and type 2
diabetes in China. The operational start of Phase 3 in China should
trigger a milestone payment to Adocia, expected in the second
quarter of 2022. In parallel, the preparatory work for the Phase 3
studies in the United States and Europe has successfully been
completed. Our commercial activities are aimed at finding a partner
capable of financing the pivotal program until marketing
authorization is obtained in these regions.
- M1Pram and BioChaperone® LisPram: intensified clinical
development efforts
Adocia has intensified the clinical development of its two
product candidates, M1Pram and BC LisPram, positioned respectively
for the auto-injector pen and pump markets. These fixed
combinations of insulin and amylin analogs are expected to provide
improved medical benefits through weight loss in obese or
overweight people with diabetes, as compared to rapid insulins
administered alone. Rapid insulins are essential to the survival of
many patients. They generate more than $9 billion in revenue each
year. In the United States, 65% of type 1 diabetic patients and 85%
of type 2 diabetic patients are overweight or obese1,2.
A Phase 2 study (CT041) was initiated in March 2021 with M1Pram
in an auto-injector pen. This comes after the establishment of
proof of concept in humans in a study from 2020 that demonstrated
improved glycemic control and very significant weight loss, as
compared to the reference rapid insulin aspart, in only 3 weeks of
treatment. The CT041 study, which aims to confirm these results
over a 4-month period in people with type 1 diabetes, has been
designed to define all the parameters of a future Phase 3 program.
The results will be communicated in the second quarter of 2022.
Concurrently, a proof-of-concept study in humans has been
initiated with BC LisPram. This combination has been specifically
designed for automated pump administration using an algorithm. This
study is being conducted in collaboration with Dr. Ahmad Haidar of
McGill University (Canada) and results are expected in Q3 2022.
New proprietary technology platforms
in new growth markets
- Revolutionizing islet transplantation (AdoShell®
technology)
In January 2021, Adocia announced the filing of patents on a
hydrogel matrix designed to improve islet transplantation cell
therapy treatments. The function of this matrix is to maintain
transplanted cells’ secretory activity, while protecting them from
the immune system. Adocia's objective is to create an organoid
capable of secreting insulin in response to glycemic variations,
thus avoiding the use of immunosuppressive drugs. An academic
collaboration has been established with several teams, including
Inserm with Professor François Pattou, a world specialist in islet
transplantation. Animal trials are underway, prior to human
implantation trials.
- Combining hormones to treat obesity
In 2021, Adocia also initiated new projects in the field of
obesity. Patient management is undergoing major changes, due, on
the one hand, to gradual recognition of obesity as a pandemic
requiring drug treatment, and, on the other hand, to the discovery
of the efficacy of certain hormones - which are also involved in
diabetes - in controlling weight. These treatments make it possible
to avoid recourse to bariatric surgery. These products are intended
to be administered in pump so that the patient can set up, with the
support of a doctor, a personalized treatment adapted to lifestyle.
Patents have been filed by Adocia on these pump-administered
hormone combinations. The objective is to prepare a
proof-of-concept study in humans by 2022/2023. These hormonal
combinations could also be developed in other medical indications
such as NASH (Non-Alcoholic Steatohepatitis) and type 2
diabetes.
- Delivering peptides in oral form that were previously
administered by injection (AdOral® technology)
Adocia has developed a technology that can enable oral delivery
of peptides by limiting their natural degradation in the digestive
tract before reaching the bloodstream. Initial results obtained in
preclinical studies have shown an increase in the absorption
efficiency of peptides by the gastrointestinal tract, which would
allow for a switch from injectable to oral forms.
This new technological platform opens up numerous applications
for oral forms of therapeutic peptides used in metabolic
disorders.
"Promising results obtained on our two platforms, AdoShell® for
cell therapy and AdOral® for the delivery of oral peptides,
position us well amongst competition on these subjects which
represent major therapeutic challenges", commented Olivier Soula,
Adocia's Deputy CEO and Director of R&D.
The company's cash position was strengthened in October 2021 by
a financing operation and in March 2022 by a real estate
transaction:
- The financing operation achieved in October was for €7
million
In October 2021, the Company carried out a financing transaction
through (i) the issue of 6,568,422 bonds convertible into shares
with a par value of one euro each for a total amount of €6 million
net subscribed by Vester Finance and two other European investors
and (ii) a capital increase of €1 million, the subscription of
which was reserved for the benefit of Gérard Soula, the Company's
Chairman and CEO and a shareholder, by way of the issue of new
ordinary shares.
In June 2021, Adocia strengthened its Board of Directors with
the appointment of three new independent members: Dr. Claudia
Mitchell, Senior Vice President in charge of Portfolio Strategy at
Astellas Pharma; Dr. Katherine Bowdish, President and CEO of PIC
Therapeutics; and Stéphane Boissel, CEO of SparingVision.
Post-period events
In March 2022, the Company completed a sale and leaseback
transaction resulting in the sale of its building, acquired in
2016, and the signature of a 12-year renewable lease. This
transaction resulted in a net cash inflow of €19 million. As of
March 28, 2022, the Company's cash position thus amounted to €28
million.
In April 2022, the Company announced the start of the BC Combo
clinical program in Europe following the approval of the Chinese
and German health authorities. BC Combo has been licensed to
Tonghua Dongbao, which has given the conduct of these clinical
studies to Adocia due to its expertise and the experience in
clinical studies management. These studies, financed by Tonghua
Dongbao, aim at qualifying the formulation necessary for the Phase
3 dossier.
Outlook for 2022
- With the enrollment of the first patients in Phase 3 of BC
Lispro in China, Adocia will be eligible for a milestone payment
under the agreement with Tonghua Dongbao (agreement providing up to
$35 million in development milestone payments until the product
registration). The commercialization of BC Lispro in China and
other Asian countries (excluding Japan) will result in the payment
of royalties on sales.
- Phase 2 clinical data for M1Pram, a rapid-acting insulin for
auto-injector pen for type 1 diabetes patients, will be reported in
the second quarter of 2022.
- Phase 1 clinical results for BC LisPram, for automated pump
administration, are expected in the third quarter of 2022.
- Pre-clinical results for multi-hormone obesity therapies
(PramExe and BC GluExe), the hydrogel matrix for cell therapy and
the oral delivery technology are expected to enable first-in-man
studies in 2022-2023.
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 three 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 a first application in pancreatic cells
transplantation for patients with "brittle" diabetes.
Adocia holds more than 25 patent families and was ranked 4th and
7th in the French National Institute of Industrial Property (INPI)
ranking of SMEs on the number of patents filed, in 2019 and 2020
respectively.
Based in Lyon, the company has approximately 115 employees.
Adocia is listed on the EuronextTM Paris market (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 which are set forth
in the “Risk Factors” section of the universal registration
document that was filed with the French Autorité des marchés
financiers on April 20, 2021 (a copy of which is available at
www.adocia.com), in particular uncertainties that are linked to
research and development, future clinical data, analyses, and the
evolution of the economic context, the financial markets and the
markets in which Adocia operates.
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 as of this day. The occurrence of all or part
of such risks could cause that actual results, financial
conditions, performances, or achievements of Adocia be materially
different from those mentioned in the forward-looking
statements.
This press release and the information contained herein do not
constitute an offer to sell or the solicitation of an offer to buy
Adocia’s shares in any jurisdiction.
1 Conway et al, Diabetes Med 2010 April; 27(4):398-404.
BMI>25, Data for 2004-2007 period 2 Epidemiology of
Obesity and Diabetes and Their Cardiovascular Complications
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220419005778/en/
Adocia Gérard Soula CEO
contactinvestisseurs@adocia.com Tel : +33 4 72 610 610
www.adocia.com
Ulysse Communication Adocia Press and Investors Relations
Pierre-Louis Germain plgermain@ulysse-communication.com / +
33 (0)6 64 79 97 51
Margaux Puech Pays d’Alissac
mpuech@ulysse-communication.com / +33 (0)7 86 16 01 09
Bruno Arabian barabian@ulysse-communication.com / +33
(0)6 87 88 47 26
Adocia (EU:ADOC)
Historical Stock Chart
From Nov 2024 to Dec 2024
Adocia (EU:ADOC)
Historical Stock Chart
From Dec 2023 to Dec 2024
