- Cash position approximately €20.7 million as of June 30,
2021
- Phase 3 submissions in China for Ultra-Rapid Insulin
BioChaperone® Lispro
- Launch of two clinical trials on combinations of insulin and
amylin analogs: Phase 2 for M1Pram and proof-of-concept for
BioChaperone® LisPram
- Promising results and patent filings on cell therapy and
obesity programs
Regulatory News:
Adocia (Euronext Paris: FR0011184241 – ADOC) (Paris:ADOC), the
clinical-stage biopharmaceutical company focused on the treatment
of diabetes and other metabolic diseases with innovative
formulations of proteins and peptides, announces today its
financial results for the six months ended June 30th, 2021.
Half-year consolidated financial statements, expressed according
to IFRS guidelines, underwent limited review by the statutory
auditors and subsequently have been approved at the Board of
Director’s meeting held today.
"Our strategy is based on the late-stage development of our
ultra-rapid insulin in China and the studies launched on our
insulin and amylin combinations, whose expected performance could
significantly improve the treatment of diabetic patients.” Gérard
Soula, CEO of Adocia, commented, "In parallel, the first results
obtained in the fields of cell therapy and obesity are really
promising."
Key financial results
The table below compares the condensed consolidated financial
statements prepared for the six-month periods ended June 30, 2021,
and June 30, 2020, respectively:
In (€) thousands
06/30/2021 6 months
06/30/2020 6 months
Revenue
402
622
Grants, research tax credits and
others
2 126
2 950
Operating revenue
2 528
3 572
Operating expenses
(12 168)
(14 713)
CURRENT OPERATING INCOME
(LOSS)
(9 639)
(11 140)
OPERATING INCOME
(LOSS)
(9 639)
(11 140)
FINANCIAL INCOME
(LOSS)
(965)
(773)
Tax expenses
0
(23)
NET INCOME (LOSS)
(10 604)
(11 936)
The financial results of the Company as of June 30, 2021, are
characterized by:
- Revenue of €0.4 million, mostly deriving from the
licensing agreements with Tonghua Dongbao Pharmaceuticals Co. Ltd
(THDB). It reflects the contractual services provided for the
transfer and development of licensed products (BioChaperone® Lispro
and BioChaperone® Combo) as well as additional R&D services
requested by the partner.
- Other operating revenues of €2.2 million, mainly from
the research and development tax credit (“Crédit d’Impôt
Recherche”), generated from expenses from the 2021 fiscal year.
- Operating expenses totaling €12.2 million for the first
six months of 2021, a decrease of €2.5 million compared to the
first six months of 2020. This was due to, on the one hand, a
decrease in preclinical and clinical expenses, and on the other
hand, a decrease in internal expenses, in particular payroll
expenses due to the decrease in FTE1 over the period.
- Financial expenses of almost €1 million, related to
interest accruing from loans.
- Net loss before tax, taking into consideration all the
previous elements, that amounts to €10.6 million compared with
€11.9 million over the same period the previous year.
- Cash position of €20.7 million as of June 30, 2021,
compared to €28.1 million as of December 31, 2020. Cash consumption
for the first six months of 2021 was €7.4 million, slightly below
last year's level (€7.8 million).
- Financial debts amounted to €28.1 million at the end of
June 2021, compared to €28.2 million on December 31, 2020. This is
primarily due to a bond debt of €15 million subscribed with IPF
Fund II in 2019, State Guaranteed Loans (PGE) for a total of €7
million, and the bank loan contracted in 2016 to finance the
acquisition and renovation of the Company's research center and
corporate headquarters. Adocia recently opted for an additional
one-year deferral of its PGE, with first repayments scheduled for
August 2022 and an unchanged maturity (August 2026).
“Adocia is pursuing an intense clinical program on prandial
combinations while preparing a new wave of innovation on cell
therapy and obesity. The cash position is sufficient to fund these
programs but it pushes the company to maintain a strict budget
management and to prioritize our expenses”, comments Valérie
Danaguezian, Adocia’s Chief Financial Officer.
Half-year key events and
perspectives for 2021
The first half of 2021 was marked by significant advances in our
insulin pipeline, and by the initiation of new projects in cell
therapy and obesity treatment.
Significant progress was made at every maturity level of our
pipeline.
- BioChaperone® Lispro to enter Phase 3 in China
The Phase 3 application for the ultra-rapid insulin BC Lispro
has been filed with the Chinese regulatory authorities by our
partner Tonghua Dongbao. The response is expected in the third
quarter of 2021. The start of the Phase 3 in China would trigger a
milestone payment to Adocia. In parallel, the preparatory work for
the Phase 3 studies in the United States and Europe has been
successfully completed and our commercial activities are aimed at
finding a partner capable of financing the pivotal program through
marketing authorization for these territories.
- M1Pram and BioChaperone® LisPram: first-in-class
combinations with high added value
Adocia has intensified the clinical development of its two
candidates, M1Pram and BC LisPram, positioned respectively for the
auto-injector and pump markets. These fixed-dose combinations of
insulin and amylin analogs are intended to replace rapid-acting
insulins, which are essential to the survival of many patients, and
which generate more than $9 billion in revenues each year. These
combinations are intended to improve glycemic control, while
triggering weight loss in obese diabetic patients. In the United
States, 65% of type 1 and 85% of type 2 diabetic patients are
overweight or obese2,3.
A Phase 2 study (CT041) has been initiated with M1Pram in
auto-injector. This follows the establishment of the human proof of
concept, the results of which were communicated in September 2020
(CT038 - part B). M1Pram had demonstrated, in just 3 weeks of
treatment, an improvement in glycemic control and a very
significant weight loss, compared to the reference rapid insulin
aspart. The CT041 Phase 2 study, which aims to confirm these
results over a 4-month period in patients with type 1 diabetes, has
been designed to define all the parameters of the future Phase 3
program. Results are expected in the first half of 2022.
In parallel, a proof-of-concept study in humans has been
initiated with BC LisPram. This combination has been specifically
designed for Automated Insulin Delivery (pump). This study is being
conducted in collaboration with Dr. Ahmad Haidar of McGill
University (Canada) and results are expected in the first half of
2022.
- Transforming islet transplantation
In January 2021, Adocia announced the filing of patents on a
hydrogel matrix designed to improve Langerhans islets
transplantation techniques for cell therapy. The function of this
matrix is to maintain the secretory activity of the transplanted
cells, while protecting them from the immune system. Adocia's
objective is to create an organoid capable of secreting insulin in
response to glycemic variations, while avoiding the use of
immunosuppressive drugs. An academic collaboration has been
established with the Inserm team of Professor Pattou, a world
specialist in islets transplantation. Animal trials are underway,
prior to human implantation studies.
- Hormone combinations for obesity treatment, a multi-billion
euro market undergoing a major transformation
Recently, Adocia initiated new projects in the field of obesity.
Patient management is undergoing major transformation, due to the
gradual recognition of obesity as a pandemic requiring drug
treatment, and to the discovery of the efficacy of certain hormones
- which are also involved in diabetes - in weight control. These
treatments make it possible to avoid undergoing bariatric
surgery.
Adocia has succeeded in combining hormones with synergistic
effects and in formulating two hormonal combinations to address the
different profiles of obese patients.
These products are intended to be administered by pump so that
patients can initiate, with the support of their doctor, a
personalized treatment adapted to their lifestyle.
Patents have been filed by Adocia on these hormonal combinations
delivered by pump. A proof-of-concept study in humans will be
initiated in 2022.
These products could also be developed in other indications such
as NASH (Non-Alcoholic Steato-Hepatitis), and type 2 diabetes.
- A stronger Board of Directors
On the governance front, Adocia has strengthened its Board of
Directors with the appointment of three new independent members:
Dr. Claudia Mitchell, Senior Vice President of Portfolio Strategy
at Astellas Pharma; Dr. Katherine Bowdish, President and CEO of PIC
Therapeutics; and Stéphane Boissel, CEO of SparingVision.
About Adocia
Adocia is a clinical-stage biotechnology company that
specializes in the development of innovative formulations of
therapeutic proteins and peptides for the treatment of diabetes and
metabolic diseases. In the diabetes field, Adocia’s portfolio of
injectable treatments is among the largest and most differentiated
of the industry, featuring six clinical-stage products and several
pre-clinical products. The proprietary BioChaperone® technological
platform is designed to enhance the effectiveness and/or safety of
therapeutic proteins while making them easier for patients to use.
Adocia customizes BioChaperone® to each protein for a given
application.
Adocia’s clinical pipeline includes five novel insulin
formulations for the treatment of diabetes: two ultra-rapid
formulations of insulin analog lispro (BioChaperone® Lispro U100
and U200), a combination of basal insulin glargine and rapid acting
insulin lispro (BioChaperone® Combo) and two combinations of a
prandial insulin with amylin analog pramlintide (M1Pram and
BioChaperone® LisPram). The clinical pipeline also includes an
aqueous formulation of human glucagon (BioChaperone® Glucagon) for
the treatment of hypoglycemia.
Adocia preclinical pipeline includes bi-hormonal combinations
for diabetes treatment: a combination of rapid acting insulin
analogs and pramlintide (BioChaperone® AsPram), a combination of
insulin glargine with GLP-1 receptor agonists (BioChaperone®
Glargine Liraglutide). In addition, there are two bi-hormonal
products for the treatment of obesity: a combination of glucagon
and exenatide (BioChaperone® GluExe) and a combination of
pramlintide and exenatide (PramExe).
Adocia recently added a preclinical program to its pipeline with
a cell therapy initiative focused on the development of a hydrogel
scaffold for use in people with type 1 diabetes. The first patent
application supporting this program has been filed.
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 FTE: Full Time Equivalent 2 Conway et al,
Diabetes Med 2010 April; 27(4):398-404. BMI>25, Data for
2004-2007 period 3 Epidemiology of Obesity and Diabetes and
Their Cardiovascular Complications
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version on businesswire.com: https://www.businesswire.com/news/home/20210907005668/en/
Adocia Gérard Soula CEO contactinvestisseurs@adocia.com
Ph: +33 4 72 610 610 www.adocia.com
MC Services AG Adocia Press Relations Europe Raimund
Gabriel Managing Partner adocia@mc-services.eu Ph: +49 89 210
228 0
The Ruth Group Adocia Investor Relations USA Brett
Mermelstein Senior Account Executive
bmermelstein@theruthgroup.com Ph.: +1 267 639 0721
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