- Cash of €13.0 million as of December 31, 2023, with cash burn
of €3.8 million in Q4 2023
- Indebtedness reduced to a €5.6 million state-guaranteed
loan
- Continued discussions with Sanofi on M1Pram and progress in
development with the manufacturing of clinical batches for Phase 2b
in the United States
- Consolidated preclinical efficacy data on AdoShell® Islets in
preparation for first-in-human study, and interest expressed by
major pharmaceutical companies in in-licensing the technology
- Positive results on three BioChaperone® Combo clinical trials
enabled Adocia’s partner Tonghua Dongbao to prepare next
development steps with Chinese regulatory authorities
Adocia’s management will hold a web conference at 6:00 pm CET on
February 28, 2024, to discuss fourth quarter 2023 financial
results. Access the live webcast by following this link.
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, today reports financial results for its fourth quarter
of 2023 and provides a business update.
“We are emerging from an eventful 2023 as a strengthened company
and we enter 2024 with active discussions underway with Sanofi on
M1Pram, and also with key players on AdoShell Islets”, said Olivier
Soula, Adocia CEO and co-founder. “I would like to extend my
warmest thanks to Adocia's employees for their loyalty and constant
dedication during this difficult year, so that we can continue to
create and to develop high-value innovations, that have captured
the interest of the largest pharmaceutical companies. Looking
ahead, we are preparing to make 2024 a transformative year for
Adocia.”
Fourth quarter 2023 financial results
"During the fourth quarter 2023, we maintained focus on
advancing M1Pram and AdoShell Islets, as well as developing BC
Lispro and BC Combo in support of our Chinese partner. Adocia is
now in a simple and clear financial situation with debt limited to
a state-guaranteed loan of 5,6m€ with a maturity date at the end of
August 2026, and all warrants and convertible bonds have been
redeemed" said Valérie Danaguezian, Chief Financial and
Administrative Officer. "Our cash position of €13 million as of
December 31, 2023, enables us to fund planned activities until the
end of August 2024, not taking into account any payments from
existing or future partnerships. Our priority is to strengthen the
company’s financial position, primarily through partnerships, while
evaluating various financing options."
Full year audited financial results for 2023 will be published
in April 2024.
The main financial figures for the quarter are as follows:
Detail of the revenue
In thousands of euros, IFRS
standards (unaudited)
12/31/2023 (3 months)
12/31/2022 (3 months)
12/31/2023 (12 months)
12/31/2022 (12 months)
Licensing revenues
75
88
313
5 088
Research and collaboration
agreements
128
1 608
1 837
6 359
Revenue
203
1 696
2 150
11 447
The Company’s revenues are mainly derived from the licensing and
collaboration agreements signed with Tonghua Dongbao (THDB) for the
development, manufacturing and marketing of BioChaperone® (BC)
Lispro and BioChaperone® Combo in China and other Asian
territories.
Revenue for the fourth quarter of 2023 of €0.2 million
consists of services provided by Adocia’s teams on BC Combo and the
completion of three clinical trials in Europe, with positive
results announced on October 23.
Annual revenues for 2023 of €2.2 million consists of €1.5
million from THDB related to BC Combo activities and €0.6 million
from an ongoing feasibility study on the AdOral® project.
For comparison, revenue in 2022 of €11.5 million represented (i)
services performed for THDB on BC Combo, and (ii) a €4.8 million
milestone payment received in May 2022 for the recruitment and
dosing of the first patient in the Phase 3 program of BC Lispro
initiated by THDB in China.
Finally, and marginally now, 2023 licensing revenue included the
impact of the application of IFRS 15 on the treatment of the
upfront payment received from THDB in 2018, upon signature of the
licensing agreements. This represents an amount of €238,000 in
2023, compared with €262,000 in 2022. Amortization was complete as
of the end of December 2023.
Net Cash Position
The company’s cash position stood at €13.0 million as of
December 31, 2023, compared with €17.4 million as of December 31,
2022. The cash position as of end of December 2023 takes notably
into account the following major receipts and disbursements in the
second half of 2023:
- Sanofi’s payment of €10 million in July 2023 under the M1Pram
exclusivity agreement;
- The completion of a €10 million financing consisting of a €5
million private placement and the issuance of €5 million in
convertible bonds. All convertible bonds issued by the company have
been converted as of the end of September 2023, and Vester Finance
declared that it had exceeded the threshold of 10% of the Company’s
capital, positioning itself as a significant shareholder in the
Company;
- Repayment of IPF Partners debt in the amount of €10.2
million;
- The receipt of €2.5 million following the full exercise of IPF
Partners warrants.
Cash outflows from operating activities for 2023 were €14.5
million, down from last year’s outflow of €23 million (with both
periods excluding financing operations).
Net financial debt (excluding IFRS 16 impacts and derivative
instruments) was €5.7 million as of December 31, 2023, compared
with €24.1 million as of December 31, 2022. The significant
decrease in debt of €18.4 million was primarily due to (i) the
repayment of the IPF Partners loan in full, (ii) the conversion of
all convertible bonds into shares issued (i.e., -€6,8 million
compared with year-end 2022) (iii) the payment of PGE loan
maturities (state guaranteed loan) for €0.8 million and (iv)
Bpifrance’s waiver of €0.5 million on the Hinsbet program initiated
in 2012 and subsequently discontinued.
4th Quarter Highlights
M1PRAM: toward a global partnership to address a serious
unmet medical need
As a reminder, on July 5, 20231, Sanofi and Adocia signed an
option agreement giving Sanofi the exclusive right to negotiate a
worldwide partnership for M1Pram (and other insulin-pramlintide
combinations developed by Adocia). This agreement is still in force
today. Sanofi paid Adocia €10 million to acquire this right.
In December 2023, Adocia's Board of Directors approved the
creation of Pramulin Therapeutics, a 100%-owned subsidiary of
Adocia, with a view to structuring a future partnership. Pramulin
Therapeutics will be dedicated exclusively to the development of
M1Pram.
The M1Pram Medical Advisory Board met in December 2023 to
finalize the protocol for the Phase 2b study. Preparations are
underway for this clinical program, including 140 patients with
type 1 diabetes and a BMI>30kg/m², in the United States.
Manufacturing of clinical batches is underway, to ensure the launch
of the Phase 2b study during the third quarter of 2024.
In the United States alone, there are nearly 2 million
insulin-dependent people who are affected by obesity and overweight
(approximately 1 million with type 1 diabetes, and 1 million with
type 2 diabetes). Worldwide, this population is estimated at nearly
40 million. M1Pram could address an important unmet medical need
for these people by enabling weight loss while maintaining glycemic
control. It is estimated that M1Pram could generate annual sales of
several billion dollars in the United States.
ADOSHELL® ISLETS: a strategic priority
New data on AdoShell® Islets, an immunoprotective biomaterial
containing islets for the treatment of diabetes by cell therapy,
were revealed at the prestigious international congresses of the
ADA, EASD and IPITA-IXA-CTRMS2.
The data support AdoShell® Islets as a biocompatible
immunoprotective material for islet transplantation, without
immunosuppression. In vivo, in rodent diabetic models, the survival
of encapsulated islets was maintained after a 7-month study without
immunosuppression, and efficacy was established with the ability to
control hyperglycemia. Designed for minimally invasive surgery,
AdoShell® Islet has demonstrated exceptional biocompatibility.
Adocia is actively preparing a first clinical trial to bring
this technology to patients as quickly and safely as possible.
Adocia is preparing interactions with the EMA to validate the
proposed development plan. AdoShell® Islets could then be tested in
the clinic as early as 2025.
The preclinical data generated to date are attracting the
interest of major industry players, and discussions have been
initiated.
The AdoShell® matrix, as a technological platform, is also being
considered for applications with stem cells and in other
therapeutic fields (e.g., Parkinson's disease, hemophilia,
oncology, etc.). Deployment of the platform will depend on the
interest of future partners.
BC COMBO & BC LISPRO: capitalizing on our strong
partnership with THDB
Positive results from three clinical studies conducted with BC
Combo (CT046 - 47 and 48) were announced in October 20233.
Conducted by Adocia in Germany, these studies were fully funded by
Tonghua Dongbao, to which BC Combo was licensed in 2018.
The studies enrolled people with type 1 and type 2 diabetes, and
healthy Chinese volunteers, and demonstrated BC Combo efficacy,
with a good safety and tolerance profile.
The different clinical studies conducted confirm the potential
of BC Combo to reduce postprandial hyperglycemia and lower the risk
of hypoglycemia, while providing 24-hour basal control. The data
generated support the goal of effective once- or twice-daily
dosing.
The overall findings showed that BC Combo had a good
benefit/risk ratio, supporting its clinical development in the next
phase. Tonghua Dongbao is currently preparing the next stages of
development with the Chinese regulatory authorities. Treatment of
the first patient in the first Phase 3 of BC Combo, expected in
2024, would trigger a $10 million milestone payment to Adocia.
The pivotal Phase 3 program with BioChaperone Lispro, conducted
in China by Adocia’s partner Tonghua Dongbao, continues its course.
The study involves 1,300 type 1 and type 2 diabetic patients
recruited from over 100 centers across China, and the last patient
last visit (LPLV), expected in the second half of 2024, would
trigger the payment process of $10 million to Adocia.
ADORAL®: the promise of oral delivery of peptides
Aiming to overcome the challenge of oral peptide administration,
AdOral is attracting the interest of several biopharmaceutical
companies. The AdOral technology is currently being tested on
peptides from two pharmaceutical partners.
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 EuronextTM 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.
1Press Release, July 5, 2023, ADOCIA Grants Sanofi an
Exclusive Right to Negotiate a Partnership on M1Pram for 10 Million
Euros and Obtains Commitment from Investors to Provide 10 Million
Euros in Financing 2 ADA: American Diabetes Association 83
Scientific Sessions, EASD: 59th Annual Meeting of the European
Association for the Study of Diabetes, IPITA-IXA-CTRMS:
International Pancreas and Islet Transplant Association,
International Xenotransplantation Association, and Cell Transplant
and Regenerative Medicine Society joint congress 3 October
23, 2023, ADOCIA’s Partner Tonghua Dongbao Announces Positive
Results of Three Clinical Trials on BioChaperone Combo
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240227159759/en/
Adocia Olivier Soula CEO
contactinvestisseurs@adocia.com +33 (0)4 72 610 610
www.adocia.com
Ulysse Communication Adocia Relations Presse et
Investisseurs Pierre-Louis Germain Bruno Arabian
adocia@ulysse-communication.com + 33 (0)6 64 79 97 51
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