ADOCIA Announces Full Year 2024 Financial Results and Provides a Corporate and Financial Update

   -- Cash position of EUR7.5m (million) as of December 31, 2024, including: 
 
          -- EUR2m received from private placement in March 2024 
 
          -- EUR9.8m from an equity financing line ("PACEO") with Vester 
             Finance 
 
   -- Cash runway extended until Q2 2026, including EUR9.7m from the private 
      placement completed in February 2025 and a $10m milestone payment from 
      partner Tonghua Dongbao expected at the end of Q2 2025 
 
   -- Advances with our flagship projects: 
 
          -- BioChaperone$(R)$ Lispro final dosing of Phase 3 studies in China, 
             with top-line data expected in mid-2025 and submission for Chinese 
             regulatory review in 2025 
 
          -- Business priority to partner BioChaperone(R) CagriSema (stable 
             combination of cagrilintide and semaglutide) and M1Pram, covered 
             by a still-ongoing exclusivity agreement with Sanofi and a Phase 
             2b clinical program in preparation 
 
          -- Continued development of AdoShell(R) platform with plans to submit 
             clinical trial application to the regulator in 2025 
LYON, France--(BUSINESS WIRE)--April 17, 2025-- 

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 (the "Company"), announces today its annual financial results as of December 31, 2024. The consolidated statements contained herein were approved by Adocia's board of directors on April 16, 2025. Audit procedures have been completed, and the audit report is in the process of being issued. These statements will be presented to shareholders for approval at the next annual general meeting on June 11, 2025.

"The year 2024 was marked by two major events", says Olivier Soula, CEO of Adocia. "The completion of BC Lispro Phase 3 studies led to the revenue recognition of a $10 million milestone, and with market authorization being the next catalyst, it brings us closer to recurring revenue. Even more significant: the submission of patent for the stable coformulation of CagriSema, made possible by our BioChaperone technology. Since then, Adocia has made significant progress in advancing this project to ensure its industrialization and establish a partnership."

"Our cash horizon is secured until Q2 2026, thanks to the EUR9.7m capital raise in February 2025 and the payment expected in Q2 2025 of the $10m milestone from our Chinese partner" adds Mathieu-William Gilbert, CFO-COO of Adocia. "This will enable us to focus on what our shareholders are expecting from us in 2025 -- signing deals, on M1Pram and on BC CagriSema, that will secure Adocia's future in the coming years, and increase the value of the company."

Financial highlights

The following table summarizes the financial statements under IFRS for the year ending December 31, 2024 with a comparison to the year ending December 31, 2023:

 
In $(EUR.AU)$ thousands, Consolidated financial          FY 2024        FY 2023 
statements                                       (12 months)   (12 months) 
---------------------------------------------   ------------  ------------ 
Revenue                                                9,320         2,150 
----------------------------------------------  ------------  ------------ 
Grants, Research tax credit, others                    2,804         3,899 
----------------------------------------------  ------------  ------------ 
Operating revenue                                     12,124         6,048 
----------------------------------------------  ------------  ------------ 
Research and development expenses                   (14,533)      (14,813) 
----------------------------------------------  ------------  ------------ 
General and administrative expenses                  (4,995)       (5,479) 
----------------------------------------------  ------------  ------------ 
Operating expenses                                  (19,528)      (20,293) 
----------------------------------------------  ------------  ------------ 
OPERATING INCOME (LOSS)                              (7,404)      (14,244) 
----------------------------------------------  ------------  ------------ 
Other operating revenue and expenses                       0             0 
----------------------------------------------  ------------  ------------ 
OPERATING INCOME                                     (7,404)      (14,244) 
----------------------------------------------  ------------  ------------ 
FINANCIAL INCOME (LOSS)                                (965)       (6,916) 
----------------------------------------------  ------------  ------------ 
Tax                                                    (952)           (2) 
----------------------------------------------  ------------  ------------ 
NET INCOME (LOSS)                                    (9,321)      (21,162) 
----------------------------------------------  ------------  ------------ 
 

The Company's results for 2024 are characterized by:

A net loss of EUR9.3m in 2024, compared to a loss of EUR21.2m in 2023, mainly due to:

- Revenue of EUR9.3m in 2024 (compared to EUR2.2m in 2023) refer to the revenue recognition of the $10m milestone from Tonghua Dongbao partnership, triggered in December 2024 by the final dosing of the last patient that concludes the Phase 3 study of BioChaperone(R) Lispro in people with Type 2 diabetes. This milestone payment is expected to be received in cash at the end of Q2 2025 as per the payment terms of the Licensing Agreement.

By way of comparison, 2023 revenue of EUR2.2m included revenues related to feasibility studies on AdOral(R) , as well as services provided by Adocia under the collaboration with Tonghua Dongbao for the conduct of three studies in Europe on the BioChaperone(R) Combo project.

- Other operating income of EUR2.8m, consisting of the Research Tax Credit $(CIR)$ generated on the 2024 R&D expenses, compared to EUR3.9m in 2023 consisting in (i) EUR3.4m in CIR on the 2023 R&D expenses, and (ii) the EUR0.5m Bpifrance grant accounted for as income, following the recognition of the technical and commercial failure of a project on an insulin dating back to 2012.

- Operating expenses of EUR19.5m are slightly down by EUR0.8m compared to last year.

- Negative financial result of EUR1.0m reflecting the financial interest on the state guaranteed loans (the "PGE") for EUR0.1m and interests on IFRS 16 finance lease debt for EUR0.9m.

In 2023, the negative financial result of EUR6.9m was mainly due to (i) interest paid on the PGE and on the loan taken out with IPF Partners through its repayment in July 2023 for EUR0.8m, and (ii) changes in the fair value of convertible bonds and IPF warrants, which had no impact on cash.

- The 2024 net loss of EUR9.3 versus the 2023 net loss of EUR21.2m is mainly attributable to the revenue recognition of the Tonghua Dongbao partnership milestone and reduced financial costs.

A cash position of EUR7.5m as of December 31, 2024 (compared to EUR13.0m as of December 31, 2023).

The cash position at year-end 2024 reflects the following main receipts and disbursements:

- EUR2m fundraising from Gérard and Olivier Soula, a member of the management and Vester Finance in March 2024,

- EUR9.8m from the use of the equity financing line signed in March 2024 with Vester Finance in the form of a PACEO (via the issuance of 1.35 million shares out of a maximum of 1.7 million shares set in the contract),

- Repayment of EUR1.2m on the PGE.

Cash used in operating activities for 2024 was EUR16.2m, compared to EUR14.5m in 2023 on a comparable basis. Adjusted for the positive impact of the 2023 Research Tax Credit (CIR) of EUR3.4 million, cash burn amounted to EUR19.6 million, down slightly by EUR0.8 million compared to last year.

Debt (excluding IFRS16 impacts) of EUR4.5m as of December 31, 2024, compared to EUR5.7m as of December 31, 2023, decreased by EUR1.2m following the resumption of repayments of the PGE in August 2024, with the loans' maturity remaining unchanged at the end of August 2026.

Cash runway and outlook

As of December 31, 2024, the company had cash of EUR7.5m, excluding the $10m milestone payment expected to be received at the end of Q2 2025 from China partner Tonghua Dongbao.

Following the EUR9.7m financing of February 2025 (see post-closing events) and including the $10m milestone payment from Tonghua Dongbao milestone, which is expected to occur at the end of Q2 2025, Adocia is financed until Q2 2026, assuming no other partnership revenue or financing occurs.

Post-closing events

The PACEO financing agreement signed with Vester Finance on March 21, 2024(1) , has now been completed. It has enabled Adocia to raise a total of EUR11.4 million, via the issuance of 1.65 million shares (corresponding to an average exercise price EUR6.9 per share).

On March 28, 2025, Adocia announced the realization of a EUR9.7 million Private Placement(2) , through the issuance of a total number of 2,125,000 new shares, each with one share warrant attached. Gross Proceeds included EUR0.5 million from Gerard Soula, chairman of the Board and cofounder of the Company, EUR0.9 million from Vester Finance, an historical investor, EUR7 million from Armistice Capital and EUR1.3 million from a limited number of investors.

The Company intends to use 50% of the net proceeds of this Private Placement to step up development work on its AdoShell(R) Islets project, including toxicology studies and the preparation of clinical batches for the launch of the clinical trial $(FIH.UK)$ and the balance to finance the Company's general corporate purposes and cash runway to Q2 2026.

Highlights of the year 2024

Product pipeline

During 2024, Adocia continued to develop its combination of clinical and preclinical assets, strengthening its diversified pipeline of specialty products for the treatment of diabetes and obesity while maintaining tight financial control. The partnership work and discussions with Sanofi and other undisclosed potential partners are ongoing and management is confident in securing at least one partnership. The latest clinical and commercial developments in the diabetes and obesity fields, and the data generated on Adocia's various technology platforms, make Adocia confident in the high market potential of its highly differentiated technologies and expertise.

Innovative products to meet the growing demand in the diabetes and obesity markets

   -- BioChaperone(R) Lispro: Phase 3 top-line results expected in mid-2025 

Partner Tonghua Dongbao initiated two Phase 3 studies with Ultra-Rapid Insulin BioChaperone(R) Lispro in 509 people with Type 1 Diabetes and 978 with Type 2 Diabetes in 2022. The final dosing of the last Type 2 Diabetes patient was announced on December 12, 2024(3) , associated with a $10 million milestone payment to be received by Adocia at the end of Q2 2025. The last patient dosed in the Type 1 Diabetes study took place in January 2025, leading to the expected announcement of top-line results in mid-2025. Assuming successful Phase 3 results, Tonghua Dongbao plans on submitting Ultra-Rapid Insulin BioChaperone(R) Lispro for Chinese regulatory review in 2025. The granting of Marketing Authorization would lead to an additional milestone payment of $20 million and double-digit royalties on sales to Adocia.

   -- BioChaperone(R) GLP-1 -- Amylin / BioChaperone(R) CagriSema: Combining 
      next-generation obesity products 

The preclinical development of BioChaperone(R) CagriSema, which offers a stable combination of cagrilintide and semaglutide in the same delivery chamber, continues as planned. Data generated to date are promising regarding its commercial and manufacturing benefits over the combination of cagrilintide and semaglutide currently being developed by Novo Nordisk, whose product currently tested in Phase 3 trials is not combining the two peptides, but uses instead separate chambers of a single-use pen device. BioChaperone(R) CagriSema is expected to offer significant manufacturing advantages, such as enabling it to be included in existing multi-use pen platforms, allowing for four weekly injections with a single pen as opposed to one pen per week with the current formulation studied by Novo Nordisk.

Novo Nordisk is conducting twelve Phase 3 clinical trials with its dual-chamber CagriSema, in over 15,000 people, including a 400-patient long-term efficacy study that was initiated in February 2025(4) .

   -- M1Pram: Ongoing exclusive discussions with Sanofi 

M1Pram is a fixed combination of insulin and amylin analogs aimed at addressing the unmet medical need of obesity in insulin-dependent individuals. In 2024, results from a post-hoc analysis of the M1Pram Phase 2a trial were published in the renowned Diabetes, Obesity and Metabolism journal and the M1Pram program was selected for the third time to be featured on the cover(5) . In this study, M1Pram demonstrated a significant reduction in body weight (5.56 kg for participants with a BMI(6) over 30 kg/m(2), after 16 weeks) compared to insulin lispro among individuals with type 1 diabetes, marking an important advancement in addressing weight management for this specific population, for whom currently marketed obesity treatments are not approved. Alongside the weight reduction, M1Pram also enabled a 21% reduction in prandial insulin doses while maintaining effective glycemic control, without increasing the risk of hypoglycemia.

A Phase 2b clinical program in the United States, involving 140 patients with Type 1 Diabetes and a BMI>30kg/m(2), is in preparation.

Adocia has completed the manufacturing of clinical batches. The launch of the clinical trial is conditional on entering an agreement for its financing.

Adocia granted Sanofi an exclusive right to negotiate a partnership on M1Pram for EUR10 million(7) . This exclusive right remains in place with ongoing discussions for a global partnership.

   -- AdoShell(R) Islets: First-in-human study submission planned for H2 2025 

The AdoShell(R) platform, an immunoprotective biomaterial for cell therapy, is attracting interest from the scientific community and from potential pharmaceutical partners. The preclinical development continues and preparatory work to submit a clinical trial application to the regulator, remains on track for 2025.

Adocia continues to provide updates about AdoShell(R) to the medical community and presented data in 2024 at various congresses: the Cell and Gene on the Med, the SFD, the EASD and ADA. More recently in 2025, key data were also shared at the EPITA Symposium, the H.C. Wainwright 3(rd) Annual Cell Therapy Virtual Conference, the ATTD 2025 conference, and the SFD 2025 congress. The project attracted support and interest from physicians involved in pancreatic islets transplantation.

The AdoShell(R) Islets program has been selected again for two presentations at the prestigious ADA Scientific Sessions (American Diabetes Association, June 20-23, 2025, Chicago, U.S.A.), one at the ISCT 2025 (International Society for Cell & Gene Therapy, May 7-10, 2025, New Orleans, U.S.A.), and a poster at the EISG 2025 (European Islets Study Group, June 11-13, 2025, Malmö, Sweden).

   -- BioChaperone(R) Combo: Fixed combination of two gold standard insulins 

On July 10, 2024, Tonghua Dongbao announced its decision to discontinue the BioChaperone(R) Combo partnership after reassessing its R&D projects and considering recent changes in the regulatory and competitive environment(8) in China. As a result, Adocia regained, at no cost, full ownership of the rights to BioChaperone(R) Combo that had been licensed to Tonghua Dongbao for China and other territories in Asia and the Middle East. The program had demonstrated positive results in three clinical trials (CT046, CT047, CT048)(9) . The $40 million received at the signing of the license agreement on April 26, 2018, is non-refundable. While Adocia believes in the therapeutic benefit of BioChaperone(R) Combo, it does not plan at this stage to commit significant financial resources behind it and is open for a partnership to develop the product further.

Proprietary technology platforms to improve peptide delivery

   -- AdOral(R): Delivering peptides in oral form to replace injections 

Adocia has developed an oral delivery technology for peptides, enabling the transition from injectable to oral forms, and has achieved promising preclinical results on semaglutide (GLP-1). The only GLP-1 commercially available in oral form to date, Rybelsus(R) , achieved $3.4 billion in global sales in 2024(10) . Oral delivery is a key factor in increasing patient adherence for those with diabetes and/or obesity. Yet, the poor bioavailability of peptides orally administered requires the production of extremely large quantities of peptides, leading to high cost of goods sold and a supply chain constrained by limited manufacturing capacity. Adocia's AdOral technology has demonstrated so far to have improved bioavailability, suggesting that for the same peptide manufacturing capacity, more patients could be treated at a lower cost of goods.

In 2024, key data on AdOral(R) Sema was presented at the ADA congress and in 2025, at the ATTD conference (18(th) International Conference on Advanced Technologies & Treatments for Diabetes, 19-22 March, 2025, Amsterdam, The Netherlands).

Following an initial assessment phase, the AdOral(R) technology is currently covered by an undisclosed R&D collaboration agreement for an application to a novel incretin. All costs related to this agreement are to be covered by the partner.

   -- AdoGel(R): Long-acting peptide delivery to reduce injections 

Designed to enable long-term peptide delivery, AdoGel(R) is currently being studied for a once-monthly dosing of semaglutide (GLP-1). GLP-1, a market that generated over $53 billion in global revenue in 2024, is almost exclusively formulated for weekly injections(11) . AdoGel(R) 's unique technology could enable monthly or even quarterly injections.

In 2024, AdoGel(R) preclinical data were also on the spotlights at the congresses of the ADA, the EASD, the CRS. More recently, preclinical results were selected for a poster presentation at the ATTD 2025 conference (18(th) International Conference on Advanced Technologies & Treatments for Diabetes, 19-22 March, 2025, Amsterdam, The Netherlands) and for an oral presentation at the SFD 2025 congress (Congress of the Société Francophone du Diabète, April 1-4, 2025, Paris, France).

Changes in governance

In June 2024, Adocia announced the appointment of Mathieu-William Gilbert as Chief Operating Officer $(COO)$ and in September 2024, he was also appointed as Chief Financial Officer $(CFO.AU)$, in addition to his COO position. He joined Adocia following a distinguished career of over fifteen years at Novo Nordisk, where he held Vice President and General Manager positions for several subsidiaries. He strengthens Adocia's leadership team as part of the Company's strategic transformation project. He oversees Adocia's operations, administrative and financial functions, investor relations, legal affairs, and human resources. He is also a member of the Executive Committee and serves as Secretary General of the Board of Directors.

Valérie Danaguezian, who had held the position of CFO since Adocia's founding in 2005, left the Company to focus on a family project.

During its meeting held on June 13, 2024, the Board of Directors acknowledged the end of Claudia Mitchell's term of office as director, which expired at the close of the Annual General Meeting called to approve the financial statements for the year ended December 31, 2023.

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