Latest news with #Adocia
Business Wire
5 days ago
- Business
- Business Wire
ADOCIA and Tonghua Dongbao Announce Positive Topline Results of Phase 3 Clinical Trial on Ultra-Rapid Insulin BioChaperone ® Lispro (THDB0206 injection) in People with T2D
LYON, France--(BUSINESS WIRE)--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 that its partner Tonghua Dongbao releases today positive topline results on the Phase 3 clinical trial on BioChaperone ® Lispro (THDB0206 injection), a novel Ultra-Rapid Insulin formulation. Conducted by Tonghua Dongbao, this Phase 3 study (NCT05834868) was approved by the Chinese Regulatory Authorities (CDE 1). The randomized, open, multicenter study evaluated the safety and efficacy of THDB0206 injection compared to Humalog ® in adults with Type 2 diabetes. Dr LENG Chunsheng, President of Tonghua Dongbao, said: " THDB0206 injection is a new generation of ultra-rapid insulin that has demonstrated benefits for improving blood glucose control of adults with Type 2 diabetes compared with the standard of care Humalog ®. Tonghua Dongbao is committed to continue to innovate in the treatment of diabetes and obesity." Olivier Soula, CEO and Co-Founder of Adocia, added: " We are thrilled to share the positive results obtained with BioChaperone ® Lispro on this Phase 3 clinical trial on people with Type 2 diabetes. Given the well-known challenges in showing clinical improvement in this population with a new prandial insulin, we are particularly delighted with these findings. This milestone demonstrates Adocia's ability to advance its innovative treatments to the final stages of clinical development, within strategic partnerships. We congratulate Tonghua Dongbao's team for the quality of execution of a large Phase 3 trial of over 1,000 people.' Results A total of 1,040 Chinese adults with Type 2 diabetes with inadequate glycemic control and using daily multiple injections of insulin were randomized. After 26 weeks of treatment, HbA1c decreased significantly in both groups compared to the baseline. The reduction in the THDB0206 injection group was comparable to that of the Humalog ® group, meeting the primary endpoint. The key secondary endpoints were also demonstrated, with a statistically significant lower rise of blood glucose after a standard meal for the THDB0206 injection group, compared to the Humalog ® group. The 10-point self-monitoring blood glucose (SMBG) of patients at week 26, an important supportive endpoint of the trial, confirmed the advantage of this product in controlling postprandial blood glucose fluctuations, with a statistically improved daily blood glucose level. A series of prespecified subgroup analyzes of the primary HbA1c endpoint also fully confirmed the benefits of this product in long-term blood glucose control in patients with Type 2 diabetes. In addition, the safety and tolerability of THDB0206 injection were good. Most of the adverse events were mild or moderate, and the incidence of adverse events and hypoglycemic events were similar to those of Humalog ®. About BioChaperone ® Lispro BioChaperone ® Lispro was licensed to Tonghua Dongbao in 2018, as part of a Licensing Agreement covering China and other Asian countries 2. BioChaperone ® Lispro is an Ultra-Rapid Insulin, belonging to the latest generation of prandial insulins. It combines Adocia's proprietary BioChaperone ® technology with insulin lispro, the active ingredient in the standard of care, Humalog ® (Eli Lilly). This innovative formulation acts significantly faster than earlier insulin generations, effectively reducing post-meal hyperglycemia, which is a key contributor to long-term complications such as retinopathy, diabetic foot ulcers, or kidney failure. Additionally, its rapid elimination minimizes the risk of hypoglycemia, often caused when insulin level remains high after post-meal glucose levels have normalized. The faster action profile of BioChaperone ® Lispro associated to an excellent local tolerance enhances its compatibility with modern diabetes management systems, particularly insulin pump systems, and provides better integration into advanced treatment algorithms. Beyond its clinical advantages, the quick onset of BioChaperone ® Lispro improves quality of life by offering greater flexibility in dose timing. Patients can administer insulin at mealtime, or even right-after-mealtime, allowing for more accurate dosing based on known meal timing and content. This reduces the risks of overdosing or underdosing, which can lead to hypo- or hyperglycemia and their associated complications. The simplified dosing process eases the psychological burden on patients and caregivers, significantly alleviating the stress associated with diabetes management. About Tonghua Dongbao Tonghua Dongbao Pharmaceutical Co. Ltd (SHSE: 600867), is a pharmaceutical company based in Jilin province, China, specializing in the R&D, manufacturing and commercialization of insulins and other diabetes treatments. Tonghua Dongbao currently employs over 3,000 people and has sales of around $280 million. It has been listed on the Shanghai Stock Exchange since 1994, with a market capitalization of about $2.3 billion. 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, 2025, available at 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.
Yahoo
7 days ago
- Business
- Yahoo
ADOCIA Reports Second Quarter 2025 Financial Results and Provides a Business Update
Cash position of €7.1 million as of June 30, 2025 US$10 million milestone payment from partner Tonghua Dongbao and 2024 Research Tax Credit of €2.8 million received in July 2025 Current cash position secures runway until Q2 2026 LYON, France, July 23, 2025--(BUSINESS WIRE)--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 second quarter of 2025 and provides a business update. "Over the past six months, significant progress has been achieved on both AdoShell® and BioChaperone® CagriSema. Meanwhile, the arrival of semaglutide biosimilars accross many countries in 2026 presents a new opportunity for AdOral® Sema, broadening the field of possible partners. For M1Pram, we are continuing our discussions to finance and launch a Phase 2b study in the USA. Thanks to a healthy cash position, we are maintaining our ambitious business objectives for the coming months." says Olivier Soula, Chief Executive Officer of Adocia. "The US$10 million milestone payment from our Chinese partner, triggered by the completion of the first Phase 3 study of Ultra-Rapid Insulin, BioChaperone® Lispro, as well as the 2024 Research Tax Credit of €2.8 million were received shortly after the closing of the second quarter, securing our cash runway until Q2 2026. Furthermore, the quality and maturity of our pipeline of products open up new partnership opportunities that we are actively exploring." added Mathieu-William Gilbert, CFO-COO of Adocia. Second quarter 2025 financial results Financial highlights for the quarter include the following: DETAIL OF THE REVENUE In thousands of euros, IFRS standards (unaudited) 06/30/2025(3 months) 06/30/2024(3 months) 06/30/2025(6 months) 06/30/2024(6 months) Licensing revenues 0 0 0 0 Research and collaboration agreements 445 0 1,031 0 Revenue 445 0 1,031 0 The revenue of €1 million for the first semester 2025 is mainly related to the feasibility study on the AdOral® technology, applied to a novel incretin for an undisclosed partner. Net Cash Position The Company's cash position stood at €7.1 million as of June 30, 2025, compared to €7.5 million as of December 31, 2024. This position includes €9.7 million received from the private placement completed in February 20251. The cash burn related to activities in the first half of 2025 amounted to €11.8 million, compared to €10.6 million in the first half of 2024 (excluding financing). Net financial debt (excluding IFRS 16 impacts), consisting exclusively of state-guaranteed loans (PGE), amounted to €3.3 million as of June 30, 2025, down €0.6 million compared to March 31, 2025, following the repayments made during this quarter. The maturity of these loans remains up to end August 2026. The cash position as of June 30, 2025, of €7.1 million, together with the US$10 million received from Tonghua Dongbao and the €2.8 million in connection with the 2024 Research Tax Credit, both received in July 2025, allows the Company to fund its activities until the second quarter of 2026, it being specified that this cash runway does not take into account other potential revenues generated by existing or future partnerships. Second quarter 2025 Highlights BioChaperone® Lispro – partnered with Tonghua Dongbao Partner Tonghua Dongbao initiated two Phase 3 studies with Ultra-Rapid Insulin BioChaperone® Lispro with about 1,500 people with Type 1 or Type 2 diabetes in 2022. The last patient in the Type 1 Diabetes study was dosed in January 2025, leading to the expected announcement of top-line results in mid-2025. Assuming successful Phase 3 results, Tonghua Dongbao could submit Ultra-Rapid Insulin BioChaperone® Lispro for Chinese regulatory review in 2025. The granting of Marketing Authorization would lead to an additional milestone payment of US$20 million and double-digit royalties on sales to Adocia. BioChaperone® GLP-1 – Amylin / BioChaperone® CagriSema The preclinical development of BioChaperone® 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, which requires each peptide to be in separate chambers of a single-use pen device. BioChaperone® CagriSema is expected to offer significant manufacturing advantages, such as enabling it to be included in existing multi-use pen platforms. Proof of stability, safety and efficacy is well established, and the product is subject to appropriate intellectual property protection. The Company's priority is to secure a licensing agreement for this product. M1Pram M1Pram is a fixed combination of insulin and amylin analogs aimed at addressing the unmet medical need of obesity in insulin-dependent individuals. Adocia granted Sanofi an exclusive right to negotiate a partnership on M1Pram for €10 million2. Discussions about this partnership are still ongoing. A Phase 2b clinical program in the United States, involving 140 patients with Type 1 diabetes and a BMI3>30kg/m², has been prepared. Adocia has completed the manufacturing of clinical batches of M1Pram. The launch of this clinical trial is conditional on the signing of an agreement on the product. AdoShell® Islets The innovative AdoShell® technology platform is designed to implant human insulin-secreting cells from either deceased donors (islets of Langherans) or stem cells to provide a cure for Type 1 diabetes without immunosuppression. Adocia presented its latest preclinical data on AdoShell® technology at two scientific conferences in June: the American Diabetes Association's (ADA) 85th Scientific Sessions & the International Pancreas and Islet Transplant Association (IPITA) 2025 World Congress. The results demonstrated the major progress achieved with the AdoShell® platform. The implant has been successfully adapted to human scale. In addition, the in vitro and in vivo maturation of islets derived from immature stem cells in AdoShell® was demonstrated. Finally, the long-term functionality and efficacy of these encapsulated islets were confirmed in vivo. Preparatory work to submit a clinical trial application to the regulator for AdoShell® with human islets for 2025 remains on track. AdOral® Adocia has developed an oral peptide delivery technology, enabling the transition from injectable to oral forms, and has achieved promising preclinical results delivering semaglutide (GLP-1) orally. Data on AdOral® Sema was presented at the ATTD 2025 conference (18th International Conference on Advanced Technologies & Treatments for Diabetes, 19-22 March, 2025, Amsterdam, The Netherlands). From 2026, semaglutide will be off-patent in many countries, and many companies are preparing to launch biosimilars of Ozempic. This situation creates an opportunity for AdOral®, a patented technology for the oral delivery of semaglutide for diabetes and obesity. The AdOral® technology is currently undergoing an R&D collaboration agreement for an application to a novel incretin. All costs related to this agreement are covered by the partner. AdoGel® Designed to enable long-term peptide delivery, AdoGel® is currently being studied for a once-monthly dosing of semaglutide (GLP-1). GLP-1, a market that generated over US$53 billion in global revenue in 2024, is almost exclusively formulated for weekly injections4. AdoGel®'s unique technology could enable monthly or even quarterly injections. New preclinical results were selected for a poster presentation at the ATTD 2025 conference (18th 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). Adocia has decided to put the AdoGel® project on hold in order to concentrate its technical efforts on AdoShell®, BioChaperone® CagriSema, and AdOral®. 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, 2025, available at 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 Press Releases, February 26, 2025, ADOCIA Announces the Successful Completion of a €9.7 Million Private Placement, Extending its Cash Runway to Q2 2026; and February 28, 2025, ADOCIA Announces the Settlement-Delivery of its €9.7Million Private Placement2 Press 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 Financing3 BMI stands for Body Mass Index, calculated as the mass of a person in Kg, divided by the square of its height in meters4 Global Data, based on consolidated sales View source version on Contacts Adocia Olivier Soula CEOcontactinvestisseurs@ +33 (0)4 72 610 Ulysse CommunicationAdocia Press & Investor Relations Bruno ArabianNicolas Entzadocia@ + 33 (0)6 87 88 47 26 Sign in to access your portfolio
Business Wire
11-07-2025
- Business
- Business Wire
Number of Shares and Voting Rights of ADOCIA as of June 30 th, 2025
LYON, France--(BUSINESS WIRE)--Regulatory News: Pursuant to the provisions of article L. 233-8 II of the French 'Code de Commerce' and article 223-16 of the General Regulation of the French stock-market authorities (Autorité des Marchés Financiers, or 'AMF'), ADOCIA SA (Paris:ADOC), a French société anonyme (corporation), 115, avenue Lacassagne, 69003 Lyon, (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, releases its total number of outstanding shares as well as its voting rights as of June 30 th, 2025. * 192,300 free shares have been issued during the month in accordance with the plans detailed in section 5.1.5.2 of the 2024 Universal Registration Document, released on April 29, 2025. (1) The total number of theoretical voting rights is used as the basis for calculating the crossing of shareholding thresholds. In accordance with Article 223-11 of the AMF General Regulation, this number is calculated on the basis of all shares to which voting rights are attached, including shares whose voting rights have been suspended. (2) The total number of exercisable voting rights is calculated without taking into account the shares with suspended voting rights, in this case, shares held by the Company in the context of a liquidity agreement. It is provided for the information of the public, in accordance with the AMF recommendation of July 17, 2007. 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).
Yahoo
12-06-2025
- Business
- Yahoo
Number of Shares and Voting Rights of ADOCIA as of May 31st, 2025
LYON, France, June 12, 2025--(BUSINESS WIRE)--Regulatory News: Pursuant to the provisions of article L. 233-8 II of the French "Code de Commerce" and article 223-16 of the General Regulation of the French stock-market authorities (Autorité des Marchés Financiers, or "AMF"), ADOCIA SA (Paris:ADOC), a French société anonyme (corporation), 115, avenue Lacassagne, 69003 Lyon, (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, releases its total number of outstanding shares as well as its voting rights as of May 31st, 2025. Month Date Total number of outstanding shares Total number of theoretical voting rights (1) Total number of exercisable voting rights (2) May 05/31/2025 18,087,690 20,213,633 20,168,948 (1) The total number of theoretical voting rights is used as the basis for calculating the crossing of shareholding thresholds. In accordance with Article 223-11 of the AMF General Regulation, this number is calculated on the basis of all shares to which voting rights are attached, including shares whose voting rights have been suspended. (2) The total number of exercisable voting rights is calculated without taking into account the shares with suspended voting rights, in this case, shares held by the Company in the context of a liquidity agreement. It is provided for the information of the public, in accordance with the AMF recommendation of July 17, 2007. 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). View source version on Contacts Adocia Olivier Soula CEOcontactinvestisseurs@ Tel: +33 4 72 610 Ulysse Communication Adocia Media and Investor Relations Bruno ArabianNicolas Entzadocia@ + 33 (0)6 87 88 47 26 Sign in to access your portfolio
Business Wire
12-06-2025
- Business
- Business Wire
Number of Shares and Voting Rights of ADOCIA as of May 31
LYON, France--(BUSINESS WIRE)--Regulatory News: Pursuant to the provisions of article L. 233-8 II of the French 'Code de Commerce' and article 223-16 of the General Regulation of the French stock-market authorities (Autorité des Marchés Financiers, or 'AMF'), ADOCIA SA (Paris:ADOC), a French société anonyme (corporation), 115, avenue Lacassagne, 69003 Lyon, (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, releases its total number of outstanding shares as well as its voting rights as of May 31 st, 2025. (1) The total number of theoretical voting rights is used as the basis for calculating the crossing of shareholding thresholds. In accordance with Article 223-11 of the AMF General Regulation, this number is calculated on the basis of all shares to which voting rights are attached, including shares whose voting rights have been suspended. (2) The total number of exercisable voting rights is calculated without taking into account the shares with suspended voting rights, in this case, shares held by the Company in the context of a liquidity agreement. It is provided for the information of the public, in accordance with the AMF recommendation of July 17, 2007. 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).
