• Cash position of €10.3 million as of June 30, 2024
• Net loss of €8.9 million as of June 30, 2024, comparable to the same period in 2023
• Debt limited to a state-guaranteed loan amounting to €5.7 million
• M1Pram: partnership discussions with Sanofi still ongoing
• Phase 3 BioChaperone^® Lispro: completion of the first study expected in December 2024, associated with a $10 million milestone payment
• AdoShell^® Islets: preparation of the first clinical trial

LYON, France--(BUSINESS WIRE)--Sep. 19, 2024-- Regulatory News:

Adocia (Euronext Paris: FR0011184241 – ADOC, the “Company”), 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 financial results for the six months period ended June 30^th, 2024, and provides a business update.

Half-year consolidated financial statements of the Company, 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 on September 18^h, 2024.

"Metabolic disorders have become one of the most active pharma spaces for innovation and partnering. Most recently, many presentations at the EASD congress highlighted the medical importance of amylin, characterizing M1Pram, and the need to improve drug delivery for obesity treatments”, said Olivier Soula, CEO of Adocia. “In this context, our products and technologies are gaining increasing industry traction. Our business activity is intense, and we are very confident in our commercial prospects".

"We have maintained the rigorous management of our operational expenses as we wait for the signing of one or more of the partnerships currently under discussion. Our cash runway provides us with visibility into Q3 2025, not including the $10 million milestone payment expected from Tonghua Dongbao for BC Lispro, and any additional payments related to new strategic partnerships", added Valérie Danaguezian, Chief Financial Officer of Adocia.

Key financial results of first half 2024

The table below compares the condensed consolidated financial statements prepared for the six-month periods ended June 30, 2024, and June 30, 2023, respectively:

The Company’s results as of June 30, 2024, are characterized by the following key elements:

• Adocia did not record any revenue in the first half of 2024. In 2023, during the same period, revenue of €1.6 million reflected income from the feasibility studies on AdOral^® as well as services provided by Adocia under the collaboration agreement with Tonghua Dongbao for the conduct of three clinical studies in Europe on the BioChaperone^® Combo project.
• Other current operating income amounted to €1.4 million, a decrease of €0.8 million compared to the first six months of 2023. This decline is explained by a €0.3 million reduction in the Crédit d’Impôt Recherche (Research Tax Credit) due to lower eligible expenses, as well as the recognition in 2023 of a €0.5 million debt forgiveness from Bpifrance related to the HinsBet program initiated in 2012 and subsequently discontinued.
• Operating expenses amounted to €9.7 million, a decrease of €1.5 million compared to the first six months of 2023. This decrease is mainly due to lower external R&D expenses following the completion of preclinical and clinical studies on BioChaperone^® Combo under the collaboration agreement with THDB, a reduction in fees, and a 7% decrease in the payroll.
• Financial expenses amounted to €0.7 million, mainly related to lease contract charges. The €1.5 million decrease compared to the first six months of 2023 is due to the reduction in debt (senior debt and convertible bonds) during the second half of 2023.
• A before-tax deficit, considering the above factors, stands at €8.9 million, in line with the previous year’s loss for the same period (€9.4 million).
• A cash position of €10.3 million as of June 30, 2024, compared to €13.0 million as of December 31, 2023. This includes €2 million raised during a private placement in March 2024 and €5.9 million from the use of the equity financing line (through the issuance of 745,000 shares out of a maximum of 1.7 million shares planned under the contract). Cash burn related to activities for the first six months of the year amounted to €10.6 million, similar to the previous year over the same period and on a comparable basis (adjusting 2023 for the receipt of the Research Tax Credit).

The cash position as of June 30, 2024, of €10.3 million allows the Company to fund its activities until the third quarter of 2025, without taking into account potential revenues from existing or future partnerships, but considering the full use of the equity financing line signed in March 2024 with Vester Finance¹.

• Net financial debt (excluding IFRS 16 impacts) stood at €5.7 million at the end of June 2024, remaining stable compared to December 31, 2023. This debt is solely composed of loans under the State-Guaranteed Loans (Prêts garantis par l’Etat or PGE), with quarterly repayments resuming in August 2024 following the restructuring of the repayment schedule.

First Half 2024 Business Update

During the first half of 2024, discussions with Sanofi continued to structure an agreement regarding M1Pram, a combination of prandial insulin and an amylin analog. The Phase 3 BioChaperone^® Lispro (ultra-rapid insulin) program being conducted in China by partner Tonghua Dongbao is ongoing, with the last patient visit (LPLV) expected in December 2024. Additionally, Adocia has regained full rights to BioChaperone^® Combo (a combination of basal and prandial insulin) following Tonghua Dongbao's strategic decision to terminate the program after reevaluating its R&D projects and considering changes in the regulatory and competitive environment. The R&D teams remain primarily dedicated to advancing the breakthrough AdoShell^® Islets technology (cell therapy) and preparing for its clinical entry.

M1Pram

Following the option agreement signed in July 2023 between Sanofi and Adocia, negotiations continue to structure a global partnership. The exclusivity agreement remains in effect.

M1Pram is a fixed combination of insulin and amylin analogs aimed at addressing the unmet medical need of obesity in insulin-dependent individuals. Preparation for the Phase 2b clinical program in the United States, which plans to include 140 patients with type 1 diabetes and a BMI > 30 kg/m², is ongoing, and clinical batches have been manufactured.

BioChaperone^® Lispro - Partnership with Tonghua Dongbao

BioChaperone^® Lispro, currently in Phase 3, holds an important position in Tonghua Dongbao's pipeline. The large-scale clinical program in China, involving 1,500 individuals with type 1 or type 2 diabetes, is progressing, with the last patient visit (LPLV) expected in December 2024. Reaching this milestone would trigger the process for a $10 million payment as per the licensing agreement entered into between the Company and Tonghua Dongbao. This agreement also includes an additional $20 million payment upon obtaining the first marketing authorization for BioChaperone^® Lispro, as well as double-digit royalties on sales.

AdoShell^® Islets

The AdoShell^® platform, an immunoprotective biomaterial for cell therapy, is attracting interest from potential pharmaceutical partners with whom discussions are ongoing.

In 2024, the Adocia’s teams attended several international conferences to present our latest results: the American Diabetes Association (ADA) in Orlando, the European Islet Study Group 2024 (EISG) in Helsinki, and the European Association for the Study of Diabetes (EASD) in Madrid.

Adocia is engaging with regulatory authorities to prepare for a first human study, scheduled for 2025.

AdoGel^®

Designed for the long-term delivery of peptides, AdoGel^® is currently being studied for semaglutide (GLP-1). GLP-1, a market which generated more than $37 billion worldwide revenue in 2023², is currently almost exclusively formulated for weekly injections. AdoGel^®’s unique technology could potentially enable monthly or even quarterly injections.

The promising preclinical results were presented at the American Diabetes Association (ADA) conference in June, the Controlled Release Society (CRS) in July in Bologna, and the European Association for the Study of Diabetes (EASD) in September in Madrid.

AdOral^®

Adocia has developed a peptide oral delivery technology, which allows injectable forms to be transitioned into oral forms. This program was also highlighted at the American Diabetes Association (ADA) conference with preclinical results obtained on semaglutide (GLP-1). The only GLP-1 commercialized in oral form to date, Rybelsus^®, achieved $2.7 billion worldwide in 2023³. Oral delivery is a key factor in increasing adherence among patients with diabetes and/or obesity.

The AdOral^® technology was being studied on peptides from two pharmaceutical partners. The encouraging results obtained are enabling discussions to move forward to determine the next steps in these collaborations.

Post-period Event

BioChaperone^® Combo

On July 10, 2024, Tonghua Dongbao announced its decision to terminate the BioChaperone^® Combo program after reassessing its R&D projects and considering recent changes in the regulatory and competitive environment⁴. As a result, Adocia regains full ownership of the rights to BioChaperone^® Combo at no cost. The program had shown positive results in three clinical trials (CT046, CT047, CT048)⁵. The $40 million received by the Company upon signing the licensing agreement on April 26, 2018, is non-refundable.

Governance

At the beginning of June, Adocia announced the appointment of Mathieu-William Gilbert as Chief Operating Officer. Mathieu-William previously held Vice President and General Management positions at Novo Nordisk. He strengthens Adocia’s leadership team as part of the company’s strategic transformation project. He oversees Adocia’s operations and contributes to accelerating its development and growth.

The term of office of Claudia Mitchell, independent board member, ended following the shareholders’ general meeting held on June 13, 2024. In addition, Katherine Bowdish resigned from her office as of September 16, 2024. The Board of Directors, which met on September 18, 2024, acknowledged Claudia Mitchell’s term of office and the resignation of Katherine Bowdish. It warmly thanks Claudia Mitchell and Katherine Bowdish for their commitment and contributions, particularly within the committees. As a replacement of the office held by Katherine Bowdish, the Board of Directors co-opted Valérie Moumdjian as a director, considered as an independent director, and appointed her as a member of the Audit Committee and the Compensation Committee. Her co-optation as director will be submitted for shareholders’ ratification at the next Annual shareholders’ meeting of Adocia.

The Board of Directors is now composed of 6 members, 4 men and 2 women. Among these members, 4 directors are independent.

Participation in Investor Events

Adocia will be participating in several investor events in the coming months:

• HealthTech Innovation Days (September 17-18, 2024, Paris)
• Lyon Pôle Bourse (September 24, 2024, Lyon)
• Portzamparc Biotech & Health Seminar (October 8-9, 2024, virtual)
• Investor Access (October 15-16, 2024, Paris)
• BIO-Europe Fall (November 4-6, 2024, Stockholm)
• Investir Day (November 26, 2024, Paris)
• ODDO BHF Forum (January 15-16, 2025, Virtual)
• JPM 2025 – 43rd Annual Healthcare Meeting (January 13-16, 2025, San Francisco)

During these professional meetings with the financial community, through "one-to-one" formats or plenary presentations, Adocia's management will review the latest updates and future prospects for the company.

Availability of the 2024 half-year financial report

The 2024 half-year financial report of Adocia will be filed with the French Financial markets authority (Autorité des marchés financiers). It will be available to the public and consultable on the www.adocia.com website in the Investors – Regulated information section.

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 different 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 set forth in the “Risk Factors” section of the universal registration document that was filed with the French Autorité des marchés financiers on April 29, 2024, as updated in the Company’s 2024 Half-year financial statements, both available at www.adocia.com . Those risks include uncertainties inherent in Adocia's short- or medium-term working capital requirements, in research and development, future clinical data, analyses and the evolution of economic conditions, 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 at this time. The occurrence of all or part of such risks could cause the actual results, financial conditions, performances, or achievements of Adocia be materially different from those mentioned in the forward-looking statements.

^{_________________________________
1} Calculated on the basis of a theoretical share price of €7 applied to all remaining shares under the equity financing line (see Adocia’s press release dated July 24, 2024).
² Source: Global Data, based on consolidated sales
³ Source: Global Data, based on consolidated sales
⁴ P. Release, July 10, 2024, ADOCIA Announces that Tonghua Dongbao is Discontinuing one of the two Partnership Programs: BioChaperone Combo
⁵ Press Release, October 23, 2023, ADOCIA’s Partner Tonghua Dongbao Announces Positive Results of Three Clinical Trials on BioChaperone Combo

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Adocia

Olivier Soula
CEO

contactinvestisseurs@adocia.com
+33 (0)4 72 610 610
www.adocia.com

Ulysse Communication

Adocia Press & Investor Relations
Bruno Arabian
Nicolas Entz

adocia@ulysse-communication.com
+ 33 (0)6 87 88 47 26

Source: Adocia