- Cash of €13.0m (million) as of December 31, 2023 (€17.4m as of
December 31, 2022), including:
- The signing of an exclusivity agreement with Sanofi on M1Pram
and payment of €10m
- The July 2023 €10m financing operation
- The contract termination with IPF Partners, resulting in the
repayment of all IPF debt (€10.2m) and the receipt of €2.5m from
the exercise of its warrants
- Cash position subsequently bolstered by March 2024 financing
operation, consisting of a €2m private placement and a financing
line with Vester Finance. The full utilization of the latter could
extend the cash runway to Q3 2025
- Advances with our flagship products and interest from potential
partners:
- Continuation of partnership discussions with Sanofi on M1Pram
and preparation for phase 2b study in the United States
- Preparation of the first clinical study and partnership
discussions on AdoShell® technology
- Progress of the BioChaperone® Lispro phase 3 program and
discussions between the Chinese regulatory authorities and partner
Tonghua Dongbao on the next clinical steps for BioChaperone® Combo
in China
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 obesity, announces today its annual
financial results as of December 31, 2023. The consolidated
financial statements contained herein were approved by Adocia’s
board of directors on April 23, 2024. These statements will be
presented to shareholders for approval at the next annual general
meeting on June 13, 2024.
Valérie Danaguezian, Adocia Chief Financial Officer, said: "In
fiscal year 2023, the company succeeded in improving its financial
situation by reducing drastically its indebtedness, and the
transaction with Vester Finance in March 2024 should enable us to
extend our cash runway to the third quarter of 2025."
"We are in an excellent position to create value for our
shareholders, with a mature partnership in China expected to
generate substantial revenues, negotiations underway with a
world-leading pharmaceutical company, and great interest expressed
in our cell therapy technology," added Olivier Soula, Chief
Executive Officer. “With our new financial position, we can
accelerate product development and conclude partnerships."
Financial highlights
The following table summarizes the financial statements under
IFRS for the year ended December 31, 2023 with a comparison to the
year ended December 31, 2022:
In (€) thousands, Consolidated
financial statements
FY 2023 (12 months)
FY 2022 (12 months)
Revenue
2 150
11 447
Grants, Research tax credit,
others
3 899
5 914
Operating revenue
6 048
17 361
Research and development
expenses
(14 813)
(25 898)
General and administrative
expenses
(5 479)
(4 359)
Operating expenses
(20 293)
(30 257)
OPERATING INCOME
(LOSS)
(14 244)
(12 896)
Other operating revenue and
expenses
0
11 199
OPERATING INCOME
(14 244)
(1 698)
FINANCIAL INCOME
(LOSS)
(6 916)
(4 727)
Tax
(2)
(476)
NET INCOME (LOSS)
(21 162)
(6 901)
The Company's results for 2023 are characterized by:
A net loss of €21.2m (million) in 2023, compared with a
loss of €6.9m in 2022, mainly due to:
- Revenue of €2.2m in 2023 (compared with €11.4m in
2022), including €1.5m from activities with Tonghua Dongbao (THDB)
on BioChaperone® (BC) Combo and €0.6m from a feasibility study on
the AdOral® project.
By way of comparison, 2022 sales of €11.4m included (i) services
performed for THDB on BC Combo, and (ii) a €4.8m milestone payment
received in May 2022 on recruitment and dosing of the first patient
in THDB's phase 3 BC Lispro program in China.
- Other operating income of €3.9m, comprising (i) the
Research Tax Credit (CIR) of €3.4m generated on expenses for the
2023 financial year, down from the 2022 CIR (€5.9m) reflecting the
drop in eligible operating expenses, and (ii) the €0.5m Bpifrance
grant accounted for as income, following the recognition of the
technical and commercial failure of an Insulin project dating back
to 2012.
- Operating expenses of €20.3m, a reduction of €10m
compared with 2022. This reflects lower R&D expenses, partly
offset by higher overheads.
- The €11m decrease in research and development expenses is
mainly due to lower clinical expenditures. In 2022, this item was
impacted by expenses related to the three clinical trials, which
ended in 2023, carried out as part of the partnership with THDB on
BC Combo. The year 2023 was also marked by a close monitoring of
headcounts and expenses in a tight financial context.
- The €1.1m increase in overheads compared with 2022 is mainly
due to legal and consulting expenses incurred in connection with
(i) the restructuring of IPF Partners debt, and to a lesser extent,
(ii) the financing transactions carried out.
- Negative financial income of €6.9m is mainly due to (i)
interest paid on the state guaranteed loan (PGE) and on the loan
taken out with IPF Partners through its repayment in July 2023 for
€0.8m, and (ii) changes in fair value of convertible bonds and IPF
warrants, which had no impact on cash.
- The net loss for 2023 of €21.2m declined versus 2022
(loss of €6.9m). This decrease is mainly due to the positive effect
in 2022 of the sale-leaseback transaction on the head office, which
generated income of €11.2m.
- For the record, a non-current operating income of
€11.2m was recognized in 2022 following the sale-leaseback of the
head office in March 2022. This transaction resulted in a net cash
inflow of €18.9m and generated a book gain of €16.6m. This has been
restated in accordance with IFRS16, and only the portion
constituting the rights transferred to the purchaser-lessor appears
under other non-current operating income.
A cash position of €13.0m as of December 31, 2023
(compared with €17.4m as of December 31, 2022).
The cash position at year-end 2023 reflects the following main
receipts and disbursements, mainly in the second half of 2023:
- Payment in July 2023 by Sanofi of €10m related to the M1Pram
exclusivity agreement;
- €10m financing package consisting of a €5m private placement
and a €5m convertible bond issue. All the convertible bonds issued
by the Company were converted at the end of September 2023, and
Vester Finance declared that it had exceeded the threshold of 10%
of the Company's capital, thus positioning itself as a significant
shareholder in the Company;
- Repayment of €10.2m debt to IPF Partners;
- Receipt of €2.5m from the exercise of all IPF Partners'
warrants.
Cash used in operating activities for 2023 was €14.9m, lower
than last year (€19.5m), on a comparable basis (excluding financing
operations).
Debt (excluding IFRS16 impacts and derivatives) of €5.7m as
of December 31, 2023, compared with €24.1m as of December 31,
2022, representing a net decrease of €18.4m.
This significant reduction is mainly due to (i) the repayment of
the IPF Partners loan in full, (ii) the conversion of all
convertible bonds into shares issued (-€6.8m compared with December
31, 2022) (iii) the payment of maturities linked to the PGE (State
Guaranteed Loan for -€0.8m) and (iv) the advance of €0.5m from
Bpifrance on the HinsBet® program initiated in 2012 and
subsequently discontinued.
Cash runway and outlook
As of December 31, 2023, the company had cash and cash
equivalents of €13.0m, enabling it to finance its current
operations until July 2024, excluding any income from existing or
future partnerships.
On March 21, 2024, the Company raised €2m in capital and set up
an equity financing line (PACEO) with Vester Finance for up to
1,700,000 shares.
With a €3m cash injection received on the signing of this
transaction, the company's cash runway has been extended to
November 2024, and to Q3 2025 assuming use of the entire PACEO
based on the share price at the time of its implementation.
In addition, Adocia is still in exclusive negotiations with
Sanofi for a global partnership on M1Pram, and is expecting two
milestone payments of $10m each in the second half of 2024, linked
to progress on the BioChaperone® Lispro and BioChaperone® Combo
projects in partnership with Tonghua Dongbao.
Lastly, the Company still considers accessing the financial
markets to finance its research.
Highlights of the year 2023
Product pipeline
The year 2023 was marked by progress with our flagship products,
notably M1Pram and AdoShell® Islets, which attracted the interest
of potential partners with a view to establishing licensing
agreements. At the same time, Adocia continued to support its
partner Tonghua Dongbao in the development of BioChaperone® Combo
and BioChaperone® Lispro. Finally, Adocia established in vivo
proofs of concept for its AdOral® and its AdoGel® technology
platforms. Adocia is seeking partnerships for these technology
platforms.
Major clinical advances and the deployment of technological
platforms
- M1Pram: towards a global partnership to meet a major unmet
medical need
This fixed combination of insulin analogues and amylin is
intended to provide a solution to the problem of obesity in people
with type 1 diabetes or insulin-dependent type 2 diabetes. In the
United States, 65%1 of type 1 diabetic patients are overweight or
obese, representing more than one million people. Also in the
United States, 85% of type 2 diabetics are overweight or obese2 of
whom 5% are insulin-dependent, also more than one million
people.
On July 5, 2023, Sanofi and Adocia signed an agreement granting
Sanofi exclusive rights to negotiate a worldwide partnership for
M1Pram (and other insulin-pramlintide combinations developed by
Adocia). Sanofi paid Adocia €10m for the acquisition of this
right.
On the clinical development front, the M1Pram Medical Advisory
Board met in December 2023 to finalize the protocol for a
forthcoming phase 2b study. This clinical program, involving 140
patients with type 1 diabetes and a BMI>30kg/m², is currently
being prepared in the United States. Manufacturing of clinical
batches is underway, to ensure the launch of the phase 2b study in
the third quarter of 2024.
- AdoShell® Islets: a strategic priority
In 2023, new data on AdoShell® Islets, an immunoprotective
biomaterial containing islets for the treatment of diabetes by cell
therapy, were communicated at the prestigious CTRMS international
congresses of ADA, EASD and IPITA-IXA. The data support AdoShell®
Islets as a biocompatible immunoprotective material for islet
transplantation, without immunosuppression. In vivo, in diabetic
mouse models, the survival of encapsulated islets is maintained
after a seven-month study without immunosuppression, and efficacy
has been established with the ability to control hyperglycemia.
Designed to be implanted via minimally invasive surgery, AdoShell®
Islets has demonstrated exceptional biocompatibility.
Adocia is actively working on the preparation of a first
clinical trial. Adocia is preparing interactions with regulatory
authorities to validate the proposed development plan. AdoShell®
Islets could then be clinically tested as early as 2025.
Discussions are underway to establish a partnership for the
technology.
- BioChaperone® Combo: three positive clinical
studies
Positive results from three clinical studies conducted on
BioChaperone® Combo (CT046 - 47 and 48) were announced in 2023.
Conducted by Adocia in Germany, these studies were fully funded by
Tonghua Dongbao, to whom BC Combo was licensed in 2018. Conducted
on people with type 1 and type 2 diabetes, and on healthy Chinese
volunteers, the studies demonstrated the efficacy of BioChaperone®
Combo combined with a good safety and tolerability profile.
The various clinical studies conducted confirm the potential of
BioChaperone® Combo to reduce postprandial hyperglycemia and the
risk of hypoglycemia compared with the reference premix insulin
Humalog® Mix, while ensuring basal control over 24 hours. The data
generated support the objective of effective dosing in one or two
doses per day. The overall evaluation showed that BioChaperone®
Combo has a good benefit/risk ratio, supporting its clinical
development in the next phase.
Tonghua Dongbao is currently discussing the next development
steps with the Chinese regulatory authorities. Treatment of the
first BC Combo phase 3 patient, expected in 2024, will trigger a
$10m milestone payment (out of a maximum $50m in milestone
payments, followed by royalties on future sales).
- BioChaperone® Lispro: phase 3 progresses in China
The extensive phase 3 program for BioChaperone® Lispro initiated
in 2022 is currently underway. Led by partner Tonghua Dongbao, the
program involves 1,300 people with type 1 or type 2 diabetes in
over 100 clinical research centers in China. The last patient last
visit (LPLV) scheduled for the second half of 2024 will trigger a
$10m payment. The contract provides for a maximum amount of $30m,
contingent on the achievement of future development milestones
through to product registration. Double-digit royalty payments on
future sales of Tonghua Dongbao are also planned.
Preparatory work for phase 3 trials in the United States and
Europe has been completed, with positive opinions received from the
FDA and EMA. The company is continuing its search for partners to
initiate the pivotal program until it obtains marketing
authorization for these territories, and to ensure its
commercialization.
New proprietary technology platforms to improve peptide
delivery
- AdOral®: oral delivery of peptides to replace
injections
Adocia has developed an oral peptide delivery technology, making
it possible to switch from injectable to oral forms. In addition to
improving patients' quality of life and compliance, oral forms of
peptides may be of interest in terms of product lifecycle
management, avoiding the difficulties associated with large-scale
production of sterile injectables. An initial application to
semaglutide, a GLP-1 receptor agonist used in the treatment of
diabetes and obesity, has validated this technology in preclinical
studies, demonstrating significantly improved bioavailability
compared with Rybelsus, the marketed oral form of semaglutide.
The AdOral® technology is currently being studied on peptides
from two pharmaceutical partners, and discussions are underway to
determine the next steps in these collaborations.
- AdoGel®: long-acting peptide delivery to reduce the number
of injections
AdoGel® has been designed to enable long-term delivery of
GLP-1, to reduce the number of annual administrations from 52 to
12, and to reduce the production of auto-injectors. Designed for
monthly release, AdoGel® Sema avoids an initial
concentration peak and ensures semaglutide release with a
pseudo-zero order profile in animals.
Changes in governance
In May 2023, Adocia announced the appointment of Olivier Soula
as Chief Executive Officer, by decision of the Board of Directors
which met on May 11, 2023 in Paris. Olivier Soula succeeds Gérard
Soula, who was reappointed Chairman of the Board of Directors.
Post-period events
In March 2024, the company announced that it had raised €2m from
its two main shareholders and a member of its management team and
had signed an equity financing line with Vester Finance
representing up to 12% of its capital. The details of this
operation are described in our press release of March 21,
20243.
2024 Milestones
- BioChaperone® Lispro: end of phase 3 in China expected
in the second half.
- BioChaperone® Combo: Start of the next clinical trials
currently under discussion between Tonghua Dongbao and the Chinese
regulatory authorities.
- M1Pram: start of phase 2b in the U.S.A., in people with
type 1 diabetes and a BMI >30kg/m², scheduled for the third
quarter.
- AdoShell® Islets: preparation of regulatory
interactions for first-in-human study.
- Continued deployment of the AdoGel® and AdOral®
technology platforms.
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 insulins with other classes of 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 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 26, 2023 updated by the amendment of 26 July
2023 (D.23-0346-A01) and amendment of 13 September 2023
(D.23-0346-A02), available at www.adocia.com, in particular
uncertainties inherent in research and development, future clinical
data, analyses, and the evolution of the economic context, 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 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
__________________
1 Conway B, Miller RG, Costacou T, Fried L, Kelsey S,
Evans RW, Orchard TJ. Temporal patterns in overweight and obesity
in Type 1 diabetes. Diabet Med. 2010. Apr;27(4):398-404. doi:
10.1111/j.1464-5491.2010.02956.x. PMID: 20536510; PMCID:
PMC3129711. 2 Epidemiology of Obesity and Diabetes and Their
Cardiovascular Complications 3 Press Release, March 21,
2024,
https://www.adocia.com/composants/uploads/2024/03/ADOCIA-PR-March-2024-Financing.pdf
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version on businesswire.com: https://www.businesswire.com/news/home/20240424648443/en/
Adocia Olivier Soula CEO
contactinvestisseurs@adocia.com +33 (0)4 72 610 610
www.adocia.com
Ulysse Communication Adocia Relations Presse et
Investisseurs Bruno Arabian Nicolas Entz
adocia@ulysse-communication.com + 33 (0)6 87 88 47 26
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