ADOCIA Reports Third Quarter 2024 Financial Results and Provides a Business Update
-- Cash position of EUR9.3 million as of September 30, 2024 -- Completion of the Phase 3 study on BioChaperone$(R)$ Lispro expected in December 2024, associated with a $10 million payment by Tonghua Dongbao -- Development of a stable combination of cagrilintide and semaglutide (CagriSema) using the BioChaperone(R) platform -- Ongoing partnership discussions on M1Pram with Sanofi LYON, France--(BUSINESS WIRE)--October 30, 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, reports financial results for the third quarter of 2024 and provides a business update.
"Beyond M1Pram and the other projects we are developing, we are very excited to have found a unique solution for the formulation of CagriSema, which could be a major element in the treatment of obesity in the future", says Olivier Soula, CEO of Adocia.
"We are maintaining our cash runway until the third quarter of 2025 thanks to rigorous management, focused on our strategic projects. The PACEO, established in March 2024, is a controlled financing solution pending revenues from BioChaperone Lispro and the conclusion of other partnerships that could generate significant income", adds Mathieu-William Gilbert, COO-CFO of Adocia.
Third quarter 2024 financial results
Financial highlights for the quarter include the following:
Detail of the revenue
In thousands of
euros, IFRS standards
(unaudited) 09/30/2024 09/30/2023 09/30/2024 09/30/2023
(3 months) (3 months) (9 months) (9 months)
---------- ---------- ---------- ----------
Licensing revenues 0 77 0 238
---------------------- ---------- ---------- ---------- ----------
Research and
collaboration
agreements 0 243 0 1 709
---------------------- ---------- ---------- ---------- ----------
Revenue 0 320 0 1 947
---------------------- ---------- ---------- ---------- ----------
Adocia has not recognized any revenue since the beginning of the year.
Last year, over the same period, the revenue of EUR1.9 million reflected revenues related to the ongoing feasibility studies on AdOral(R) , as well as services provided by Adocia under the collaboration with Tonghua Dongbao for conducting three clinical studies in Europe on the BioChaperone(R) Combo project.
Net Cash Position
The Company's cash position stood at EUR9.3 million as of September 30, 2024, compared to EUR13.0 million as of December 31, 2023. This position includes EUR2 million received from the private placement in March 2024 and EUR7.0 million from the use of the equity financing line signed in March 2024 with Vester Finance in the form of a PACEO(1) (via the issuance of 945,000 shares out of a maximum of 1.7 million shares set in the contract).
The cash burn related to activities for the first nine months of 2024 amounted to EUR12.6 million, compared to EUR10.8 million during the same period last year on a comparable basis (excluding financing). Adjusted for the impact of the Research Tax Credit $(CIR)$, cash burn amounted to EUR16 million, down slightly by EUR0.7 million compared to the same period last year.
Net financial debt (excluding IFRS 16 impacts), consisting exclusively of state-guaranteed loans (PGE), amounted to EUR5.2 million as of September 30, 2024, down EUR0.5 million compared to June 30, 2024, following the resumption of repayments of the PGE in August 2024, with the loans' maturity remaining unchanged at the end of August 2026.
The cash position as of September 30, 2024, of EUR9.3 million allows the Company to fund its activities until the third quarter of 2025, without considering potential revenues generated by existing or future partnerships but taking into account the full utilization of PACEO signed in March 2024 with Vester Finance(2) .
Adocia is still in exclusive negotiations with Sanofi for a global partnership on M1Pram, as well as other products. In addition, the Company expects a milestone payment of $10 million related to the progress of the BioChaperone(R) Lispro project in partnership with Tonghua Dongbao.
Third quarter 2024 Highlights
BioChaperone(R) GLP-1 -- Amylin
In a context where the obesity and diabetes markets are booming, pharmaceutical companies are striving to differentiate themselves with more effective, better-tolerated, simpler-to-use, or easier-to-produce products to meet the unmet demand. One approach is to combine different metabolic hormones, which are sometimes incompatible. Adocia, thanks to its historical BioChaperone(R) platform, has achieved this technical feat. Stable formulations of amylin and GLP-1 analogs, including cagrilintide and semaglutide ("CagriSema"), have been developed, and new patents have been filed. These combinations allow administration via standard injection devices, including multi-use ones, which would increase the number of patients treated at a constant industrial capacity for pharmaceutical companies. These patents, offering protection until 2045, should position Adocia as a potential partner for pharmaceutical players working on hormone combinations.
M1Pram
M1Pram is a fixed combination of insulin and amylin analogs aimed at addressing the unmet medical need of obesity in insulin-dependent individuals.
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 production of clinical batches. The launch of this program will be conditional on the signing of an agreement regarding the product.
Following the exclusivity agreement signed between Sanofi and Adocia(3) , which remains in effect to date, discussions regarding a potential global partnership remain ongoing.
AdoShell(R) Islets
The AdoShell(R) platform, an immunoprotective biomaterial for cell therapy, is attracting interest from potential pharmaceutical partners with whom discussions are ongoing. In the third quarter of 2024, Adocia's teams presented exclusive data at the European Association for the Study of Diabetes (EASD) in Madrid. These presentations highlighted the translational work towards a clinical object and implantation trials in large animals, conducted in collaboration with Professor Pattou from the Lille University Hospital, as well as in vivo demonstrations of AdoShell(R) compatibility with islets derived from stem cells.
Adocia has had an initial interaction with French regulatory authorities to prepare for the human study, scheduled for 2025.
BioChaperone(R) Lispro - partnership with Tonghua Dongbao
The phase 3 program, conducted in China with 1,500 people with type 1 or type 2 diabetes, is proceeding according to plan. The last patient last visit (LPLV) is expected in December 2024. The license agreement between the Company and Tonghua Dongbao provides that this milestone will trigger a $10 million payment process. This agreement also includes the payment of an additional $20 million upon the first marketing authorization for BioChaperone(R) Lispro, as well as double-digit royalties on sales.
BioChaperone(R) Combo
On July 10, 2024, Tonghua Dongbao announced its decision to discontinue the BioChaperone(R) Combo program after reassessing its R&D projects and considering recent changes in the regulatory and competitive environment(4) . As a result, Adocia regained full ownership of the rights to BioChaperone(R) Combo at no cost. The program had demonstrated positive results in three clinical trials (CT046, CT047, CT048)(5) . The $40 million received at the signing of the license agreement on April 26, 2018, is non-refundable.
AdOral(R)
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 $2.7 billion in global sales in 2023(6) . Oral delivery is a key factor in increasing patient adherence for those with diabetes and/or obesity. The AdOral(R) technology has been tested on peptides from two pharmaceutical partners and has shown encouraging results. Discussions are currently ongoing.
AdoGel(R)
Designed to enable long-term peptide delivery, AdoGel(R) is currently being studied on semaglutide (GLP-1). GLP-1, a market that generated over $37 billion in global revenue in 2023, is almost exclusively formulated for weekly injections(7) . AdoGel(R) 's unique technology could enable monthly or even quarterly injections. Promising preclinical results were presented this quarter at the Controlled Release Society $(CRS)$ conference in July in Bologna and at the European Association for the Study of Diabetes (EASD) in September in Madrid, where the importance of long-acting formulations was highlighted.
Governance
On September 23, 2024, Mathieu-William Gilbert was appointed Chief Financial Officer $(CFO.AU)$. These new responsibilities are in addition to his role as Chief Operating Officer $(COO)$, which he has held since May 2024. 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 the General Secretary of the Board of Directors.
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