ADOCIA Reports First Quarter 2024 Financial Results and Provides Business Update

• The cash position of 10.2 million euros as of March 31, 2024 includes proceeds from financing from March 20241, presenting:

  • 2 million euros invested by three members of management and Vester Finance, the Company’s second largest shareholder after the Soula family

  • An equity financing facility (“PACEO2”) with Vester Finance for a maximum of 1.7 million shares, the full utilization of which would extend the Company’s cash flow until the third quarter of 2025

• Continued partnership discussions with Sanofi on M1Pram and preparations for phase 2b trial in the United States

LYON, France, May 14, 2024–(BUSINESS WIRE)–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 quickly as possible“, declared Olivier Soula, CEO of Adocia. “At the same time, we are pleased to have expanded our cash flow, allowing 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:

Recipe detail

Q1 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, whose results were positive, were completed in 2023 and therefore did not generate any revenue in the first quarter of 2024.

Net cash position

The Company’s cash position was €10.2 million as of March 31, 2024, compared to €13.0 million as of December 31, 2023. This includes €3 million received in March 2024 as part from raising private placement funds of 2 million euros and 1 million euros advance on the equity financing line with Vester Finance. Cash used to finance operations during the first quarter of 2024 was €5.8 million, compared to €7.8 million in the prior-year quarter.

Net debt (excluding the impacts of IFRS 16) was 5.7 million euros on March 31, 2024, unchanged compared to December 31, 2023. The debt consists of a State Guaranteed Loan (PGE). Under the renegotiated August 2023 repayment schedule, the next payment will be in the third quarter of 2024.

The story continues

The Company’s cash position of 10.2 million euros as of March 31, 2024 is sufficient to finance currently planned operations until the third quarter of 2025, excluding any income from existing or future partnerships, but assuming full use of the line equity financing agreement (“PACEO”) signed in March 2024 with Vester Finance.

Adocia remains in exclusive negotiations with Sanofi for a global partnership on M1Pram and expects two payments of US$10 million each, tied to the progress of its BioChaperone® Lispro and BioChaperone® Combo projects with Tonghua Dongbao.

Highlights from the first quarter of 2024

M1Pram

Following the July 2023 agreement between Sanofi and Adocia, negotiations continue with the aim of structuring a global partnership.

M1Pram is a fixed-dose combination of insulin and amylin analogs designed to address the unmet medical need for obesity in people with type 1 diabetes.

Preparations for the phase 2b clinical program in the United States, which will include 140 patients with type 1 diabetes and BMI >30kg/m², continue with the completion 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 patient’s last appointment, currently scheduled for the second half of 2024, will generate a payment of US$10 million (out of a maximum of US$30 million in future payments, followed by royalties on net product sales).

BioChaperone® Combo

Tonghua Dongbao is actively preparing upcoming clinical studies of BioChaperone® Combo and expects to submit the program for approval by CDE, the Chinese regulatory authority. Treatment of the first patient in the first Phase 3 study of the BioChaperone® Combo, which is scheduled for the second half of 2024, will trigger a payment of US$10 million (out of a maximum of US$50 million in future milestone payments, followed 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, Medical Director of Adocia. Additional data will be presented at the American Diabetes Association (ADA) 84th Scientific Sessions in June 2024 in a presentation titled: “AdoShell®, a non-fibrotic encapsulation system for human islet 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 administration of peptides that should allow the change from injectable to oral form. An initial application to semaglutide (GLP-1) validated this technology in preclinical trials.

The AdOral® technology is currently being tested on peptides from two pharmaceutical partners, and the encouraging results obtained to date are the basis for discussions to determine next steps in these collaborations.

AdoGel®

Designed for the delivery of long-acting peptides, AdoGel® is currently being tested in semaglutide (GLP-1). Preclinical results will be presented at the ADA (American Diabetes Association) Scientific Sessions in a presentation titled: “Development of a monthly semaglutide formulation based on an innovative injectable and biodegradable hydrogel“.

About Adócia

Adocia is a biotechnology company specialized in the discovery and development of therapeutic solutions in the area of ​​metabolic diseases, mainly diabetes and obesity.

The company has a broad portfolio of drug candidates based on four proprietary technology platforms: 1) BioChaperone® technology for the development of new generation insulins and products that combine different hormones; 2) AdOral®, an oral peptide delivery technology; 3) AdoShell®, an immunoprotective biomaterial for cell transplantation, with initial application in pancreatic cell transplantation; and 4) AdoGel®, a long-acting drug delivery platform.

Adocia holds more than 25 patent families. Headquartered in Lyon, the company has around 80 employees. Adocia is listed on the regulated Euronext™ Paris market (Euronext: ADOC; ISIN: FR0011184241).

Disclaimer

This press release contains certain forward-looking statements regarding Adocia and its business. Such forward-looking statements are based on assumptions that Adocia considers reasonable. However, there can be no assurance 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 has been filed with the French Autorité des marchés financiers on April 29, 2024, available at www.adocia.com. These risks include uncertainties inherent in Adocia’s short- or medium-term working capital needs, research and development, future clinical data, analysis and developments in economic conditions, financial markets and the markets in which Adocia operates, which could impact the Company’s short-term financing needs and its ability to raise additional funds.

The forward-looking statements contained in this press release are also subject to risks not yet known by Adocia or not considered material by Adocia at this time. The occurrence of all or part of such risks could cause Adocia’s actual results, financial condition, performance or achievements to be materially different from those set forth in the forward-looking statements.

1 See the company’s press release dated March 21, 2024.
two PACEO: Capital Increase Program by Exercise of Options

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Contacts

Adócia
Oliver Soula
CEO
contactinvestisseurs@adocia.com
+33 (0)4 72 610 610
www.adocia.com

Ulysse Communication
Adocia Press and Investor Relations
Bruno Arab
Nicolas Entz
adocia@ulysse-communication.com
+ 33 (0)6 87 88 47 26

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