Breakeven Date Change • May 20
Forecast to breakeven in 2026 The 2 analysts covering Adocia expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €3.98m in 2026. Earnings growth of 55% is required to achieve expected profit on schedule. Board Change • May 20
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 2 experienced directors. 10 highly experienced directors. Independent Chairman of the Board Stephane Boissel was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Annuncio • Feb 25
Adocia SA Announces Board Changes Adocia SA announced that after 20 years as Chairman of Adocia, and as announced during the shareholders’ meeting of Adocia conducted on June 11th 2025, Gérard Soula, co-founder of the Company, is stepping down from his positions as Chairman of the Board of Directors and Board member, in consultation with the Board of Directors, in accordance with the statutory age limit. The termination of Gérard Soula’s functions will be effective as of February 23, 2026. The Board also decided that Stéphane Boissel, a director of Adocia since 2021, will succeed Gérard Soula as Chairman of the Board of Directors of Adocia. Stéphane Boissel is an experienced executive in the biotechnology sector, currently serving as President and CEO of SparingVision, a Company specializing in genomic medicine for hereditary eye diseases. After 10 years of experience in consulting and investment banking in France and internationally, he has spent the past 25 years serving as an executive leader and board member in the biotechnology sector. He previously held chief executive, strategic, and financial leadership positions at several international biotech companies, including Innate Pharma, Transgene, TxCell, and Sangamo Therapeutics in San Francisco, and currently serves as an independent member of the Board of Directors of EG427. As a replacement of the office held by Gérard Soula, the Board of Directors co-opted Jacky Vonderscher as a director, considered as an independent director. His co-optation as director will be submitted for shareholders’ ratification at the next Annual shareholders’ meeting of Adocia. Jacky Vonderscher is an experienced pharma and biotech leader. He is the CEO of ENYO Pharma SA, a Company specializing in developing therapeutics for diseases with impaired kidney function. His extensive 40 years’ experience in pharma development at Novartis and Roche, and more recently as director and leader in different biotech companies, will be a valuable contribution for the development of Adocia. Annuncio • Dec 20
Adocia SA, Annual General Meeting, Jun 03, 2026 Adocia SA, Annual General Meeting, Jun 03, 2026. Annuncio • Nov 12
Adocia Announces Filing of Patent for New Long-Acting Peptides Platform in Diabetes and Obesity - Adoxlong Adocia announced the submission of a patent for a new long-acting peptide platform, and two feasibility studies using its BioChaperone technology with two undisclosed pharmaceutical companies. The new AdoXLongTM platform has been developed to address a critical challenge in diabetes and obesity treatments based on GLP-1 agonists, amylin, or other metabolic peptide: long-acting formulations. Moving from weekly to monthly administration would significantly improve long-term treatment persistence, while reducing the manufacturing capacity required per patient, thereby increasing the number of patients who can be treated. The patented technology is a long-acting peptide platform composed of a biocompatible polymer chemically linked to the peptides without modifying their mechanisms of action. Pharmaceutical products derived from this technology are low viscosity aqueous solutions compatible with standard injection devices and administered subcutaneously using 29 Gauge or smaller needles. The technology is designed to offer a long circulating peptide over at least one month. The technology can be applied to a variety of peptides such as GLP-1, GIP, amylin, or dual/triple agonists - including semaglutide, tirzepatide, cagrilintide - with the possibility to combine these modified peptides with each other. Positive preliminary in vitro and in vivo results have been obtained with AdoXLong®? applied to semaglutide. The patent application is expected to provide worldwide protection until 2046, if granted. The peptides using the technology would also benefit from reinforced intellectual property with extension until 2046. The technology is applicable to both innovative and biosimilar peptides, including Semaglutide, which will become off-patent starting in 2026 in certain territories. Annuncio • Sep 03
Adocia Announces Oral Presentations on Adocia and Biochaperone At Easd, Esb and Podd 2025 Annual Meetings Adocia announced oral presentations highlighting the latest preclinical results obtained on its innovative technological platform AdoShell at EASD and ESB 2025 annual meetings. Adocia will also present at the next PODD 2025 its latest preclinical results on the BioChaperone platform. Oral presentations at EASD et ESB will highlight the latest AdoShell preclinical results: Successful scale up from animal to human device for First-In-Human study; In vitro and in vivo maturation after encapsulation of immature stem cell-derived islets in AdoShell; Sustained long-term in vivo function and efficacy of stem cell-derived islets encapsulated in AdoShell; EASD (European Association for the Study of Diabetes) annual meeting, Vienna, Austria, 15-19 September 2025; Title: ADO12, a non-fibrotic encapsulation system for human islet transplantation without immunosuppression; Presentation: Tuesday, September 16th 2025 - 12:00 -13:00 pm CEST; Session: It's beta cell replacement time (SO 019; 400); Room: Station 04; Authors: Ouardane Jou cannot, Anne-Lise Gaffuri, Madeleine Frelon, Gregory Blache, Julie Brun, Guillaume Lefebvre, Camille Gautier, Romain Besnard, Alexandre Martin, Claire Megret, Nicolas Laurent, Martin Gaudier, Rosy Eloy, Olivier Soula. Annuncio • Jul 25
Adocia and Tonghua Dongbao Announces Positive Topline Results of Phase 3 Clinical Trial on Ultra-Rapid Insulin BioChaperone Lispro (THDB0206 injection) in People with T2D Adocia announced that its partner Tonghua Dongbao releases 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 (CDE1). The randomized, open, multicenter study evaluated the safety and efficacy of THDB0206 injection compared to Humalog in adults with Type 2 diabetes. 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. BioChaperone Lispro was licensed to Tonghua Dongbaoin 2018, as part of a Licensing Agreement covering China and other Asian countries. 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. Annuncio • Jun 24
Adocia Announces the Presentation of the Latest Preclinical Data from its Innovative Adocia Technology Platform At ADA & IPITA Scientific Conferences Highlight Scalability and Good Translation of AdoShell Adocia announced the presentation of the latest preclinical data from its innovative AdoShell®? technology platform at ADA & IPITA Scientific Conferences Highlight Scalability and Good Translation of AdoShell®? from Human Islets to Stem Cell-Derived Islets. AdoShell®? is designed to implant human pancreatic islets from deceased donors or stem cell-derived islets cell to cure type 1 diabetes without immunosuppression. Adocia preclinical data presented at the International Pancreas and Islet Transplant Association (IPITA) 2025 World Congress, held in Pisa, Italy, June 15-18, 2025, was titled "AdoShell®?, a non-fibrotic encapsulation system for human islet transplantation without immunosuppression". After implanting AdoShell®? containing human islets in mice, C-peptide secretion increased during the first two weeks to reach a therapeutic dose (707+-218 pM) that was maintained in 100% of mice until explantation after more than 2 months. Moreover, AdoShell®? Human Islets was shown to regulate mice glycemia to human levels. In vitro, explants showed a maintained viability and glucose-responsive insulin secretion. This presentation also highlights that AdoShell has been successfully scaled-up to embark the human dose of islets for a first clinical application. The Adocia presentation at the American Diabetes Association's (ADA) 85th Scientific Sessions, held in Chicago, USA, June 20-23, 2025, focused on the application of AdoShell®? to stem cell-derived islets (SCDI). Encapsulation of SCDI in AdoShell®? maintained viability, proliferation state and secretion of insulin similar to non-encapsulated SCDI. AdoShell®? permits the maturation of immature SCDI both in vitro and in vivo. Finally, AdoShell®? enables long-term function and efficacy of SCDI in mice for at least 24 weeks. Annuncio • Apr 29
Adocia to Present New Data on AdoShell at Upcoming Scientific Conferences - Showcasing Potential Curative Treatment for Type 1 Diabetes Adocia announced the latest preclinical data from its innovative AdoShell®? technology platform have been selected for presentations at four upcoming scientific conferences. AdoShell®? Islets is an innovative immunoprotective hydrogel designed to encapsulate pancreatic islets, with the goal of curing diabetes through cell therapy without requiring immunosuppression. This semi-permeable hydrogel allows the diffusion of insulin and glucose, while preventing the infiltration of antibodies and immune cells that would lead to graft rejection. Currently, to prevent this normal body reaction, every allogeneic transplant patient must take immunosuppressive drugs on a chronic basis, with significant side effects. AdoShell®? is easily implantable and fully retrievable via laparoscopy. The new data to be presented by Adocia notably disclose the success of the scale-up to deliver the therapeutic dose for the first-in-human study, which is planned to be submitted with the regulatory authorities in 2025. In addition, new in vitro and in vivo data to be presented confirm the compatibility of AdoShell®? with stem cell-derived islets, notably their ability to mature into insulin producing cells within AdoShell®?. The integration of these stem cell-derived islets into technology represents a key step toward broader access to type 1 diabetes treatment through cell therapy, without the need for immunosuppression. Adocia envisions that AdoShell®? could be applied beyond pancreatic cells to other cell types. Data with primary and differentiated stem cells for the release of various therapeutic molecules other than insulin will also be presented, illustrating the possibility to make AdoShell®? a technology platform. Annuncio • Feb 27
Adocia SA has completed a Follow-on Equity Offering in the amount of €9.7325 million. Adocia SA has completed a Follow-on Equity Offering in the amount of €9.7325 million.
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 2,125,000
Price\Range: €4.58
Security Features: Attached Warrants
Transaction Features: Subsequent Direct Listing Annuncio • Dec 26
Adocia SA, Annual General Meeting, Jun 11, 2025 Adocia SA, Annual General Meeting, Jun 11, 2025. Annuncio • Dec 13
Adocia and Tonghua Dongbao Pharmaceutical Co. Ltd Announce the Final Dosing in A Phase 3 Clinical Study of Biochaperone®? Lispro Adocia announced the completion of the final dosing of the last Type 2 diabetes patient in a Phase 3 clinical trial evaluating BioChaperone® Lispro, the Company's novel ultra-rapid insulin. This clinical trial is being conducted in China by Adocia's partner, Tonghua Dongbao Pharmaceutical in people with Type 2 Diabetes. The final dosing of the last type 2 diabetes patient is associated with a milestone payment of $10 million to Adocia. This payment will be received in the second quarter of 2025 as per the payment terms of the Licensing Agreement. A second study in people with Type 1 diabetes is nearing the end of treatment, which is expected to be in early 2025. Both Phase 3 topline results, in people with Type 1 and Type 2 diabetes, are expected in first quarter of 2025. Tonghua Dongbao is expected to submit the Marketing Authorization Application to the Chinese Centre for Drug Evaluation (CDE) in 2025. The grant of the Marketing Authorization would lead to an additional milestone payment of $20 million and double-digit royalties on sales to Adocia. The Phase 3 clinical program, conducted by Tonghua Dongbao, involves over 1,500 people with Type 1 and Type2 diabetes in 100 clinical centres across China. The aim of both pivotal trials is to demonstrate the safety and efficacy of BioChaperone®Lispro compared to standard of care Humalog® (Eli Lilly). The primary efficacy endpoints is the change in HbA1c (glycosylated haemoglobin) from baseline to 26 weeks of treatment, with a non-inferiority objective. The secondary efficacy endpoints are 1-hour and 2-hour Postprandial Glucose (PPG) excursions at week 26. BioChaperone®Lispro was licensed to Tonghua Dongbao in 2018, as part of a Licensing Agreement covering China and other Asian countries. Buy Or Sell Opportunity • Oct 31
Now 22% undervalued Over the last 90 days, the stock has risen 54% to €9.05. The fair value is estimated to be €11.54, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has declined by 7.3% over the last 3 years. Earnings per share has grown by 21%. Annuncio • Oct 15
Adocia SA Announces Patenting Stable Combinations of GLP-1 and Amylin Analogs for the Treatment of Obesity and Diabetes Using Its BioChaperone® Platform Adocia announced that it has filed patents of stable formulations of hormone combinations for the treatment of obesity and diabetes using its BioChaperone® platform. Several families of hormones can be used to achieve significant weight loss, starting with GLP-1 (e.g. semaglutide, tirzepatide), but also amylin analogs (e.g. cagrilintide, eloralintide, petrelintide…), which would have the advantage of targeting fat mass, while preserving muscle mass. Future generations of obesity treatments, for which analysts expect the market to reach USD 100 billion by 2030, combine these different mechanisms of action to achieve better weight loss in terms of both quantity and quality. However, this promising strategy is hampered by the incompatibility of many of these hormones, which cannot be formulated into a single product. To avoid double injection, pharmaceutical companies are developing injection devices, such as dual-chamber injectors, but they are limited to single use and are more complex to manufacture. Adocia has patented, among other examples, a stable combination of cagrilintide and semaglutide (“CagriSema”, amylin analog and GLP-1 receptor agonist respectively, Novo Nordisk) with BioChaperone®, which could be administered in standard single- and multiple-use auto-injectors or pens, representing an improvement over a dual-chamber device. The value of Adocia's innovation also lies in the intellectual property generated, which aims to extend the protection of these combinations by several years. The patent applications filed aim to provide worldwide protection for the combinations covered until 2045. Reported Earnings • Sep 25
First half 2024 earnings released: €0.62 loss per share (vs €1.03 loss in 1H 2023) First half 2024 results: €0.62 loss per share (improved from €1.03 loss in 1H 2023). Revenue: €1.45m (down 63% from 1H 2023). Net loss: €8.95m (loss narrowed 4.8% from 1H 2023). Revenue is forecast to grow 70% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 21% per year but the company’s share price has fallen by 17% per year, which means it is significantly lagging earnings. New Risk • Sep 21
New minor risk - Revenue size The company makes less than US$5m in revenue. Total revenue: €3.6m (US$4.0m) This is considered a minor risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (13% average weekly change). Negative equity (-€6.9m). Minor Risks Shareholders have been diluted in the past year (31% increase in shares outstanding). Revenue is less than US$5m (€3.6m revenue, or US$4.0m). Market cap is less than US$100m (€85.3m market cap, or US$95.2m). New Risk • Jul 11
New major risk - Revenue and earnings growth Earnings have declined by 8.5% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Negative equity (-€6.9m). Earnings have declined by 8.5% per year over the past 5 years. Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Minor Risk Share price has been volatile over the past 3 months (9.7% average weekly change). Annuncio • Jun 05
Adocia Announces Appointment of Mathieu-William Gilbert as Chief Operating Officer Adocia SA announced the appointment of Mathieu-William Gilbert as Chief Operating Officer (COO). Mathieu joins Adocia after serving as Vice-President Strategic Projects of International Commercial Operations at Novo Nordisk. Prior to this, he held the position of Vice President & General Manager of six Latin American countries, with responsibility for all Novo Nordisk activities in the region, as well as the establishment of the Obesity franchise and the commercial launch of Ozempic®. Mathieu began his career with KPMG and Sanofi Aventis, in internal control and auditing, before joining Novo Nordisk's finance functions and being appointed CFO of Algeria and then of the Latin American region. Throughout his career, Mathieu has been passionate about innovative solutions for patients and leading his teams to success. His appointment reflects Adocia's commitment to strengthening its management team and reinforcing its position as an innovative company in the field of diabetes and obesity. Board Change • Jun 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 1 experienced director. 11 highly experienced directors. Independent Director Stephane Boissel was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Annuncio • May 16
Adocia SA announced that it has received €2 million in funding On May 14, 2024, Adocia SA closed the transaction. Annuncio • May 09
Adocia SA, Annual General Meeting, Jun 13, 2024 Adocia SA, Annual General Meeting, Jun 13, 2024. Location: 2 rue de saint florentin, paris France Reported Earnings • Apr 26
Full year 2023 earnings released Full year 2023 results: Revenue: €6.05m (down 65% from FY 2022). Net loss: €21.2m (loss widened 207% from FY 2022). Revenue is forecast to grow 84% p.a. on average during the next 2 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Reported Earnings • Apr 25
Third quarter 2023 earnings released Third quarter 2023 results: Revenue: €1.07m (down 69% from 3Q 2022). Net loss: €5.89m (loss widened 5.5% from 3Q 2022). Revenue is forecast to grow 83% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. New Risk • Apr 07
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Negative equity (-€18m). Shareholders have been substantially diluted in the past year (58% increase in shares outstanding). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Share price has been volatile over the past 3 months (8.5% average weekly change). New Risk • Nov 17
New major risk - Revenue and earnings growth Earnings have declined by 14% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Negative equity (-€18m). Earnings have declined by 14% per year over the past 5 years. Shareholders have been substantially diluted in the past year (63% increase in shares outstanding). Annuncio • Nov 10
Adocia Reveals Promising Preclinical Data on Adocia Islets for Cell Therapy of Diabetes Adocia disclosed additional results on AdoShell Islets during recent international congresses. Islet transplantation has long been recognized as an effective treatment for Type 1 Diabetes (T1D). However, the limitations imposed by the requirement for immunosuppression have hindered its widespread application. Adocia has set out to overcome this hurdle and has developed AdoShell Islets, an implantable and fullyretrievable scaffold for islet transplantation that eliminates the need for immunosuppression drugs while ensuring the success of the transplantation procedure. AdoShell is based on a permselective hydrogel scaffold, reinforced by a mechanical frame, specifically designed to facilitate the diffusion of insulin while effectively preventing the invasion of immune cells. This innovative biomaterial, comprised of 95% water, is synthesized using non-degradable polymers cross-linked by bio-orthogonal click chemistry. This technology is protected via three patent applications4. Human islets encapsulated in AdoShell®? scaffold maintain, in vitro, a gluco-responsive insulin secretion comparable to naked islets. The outcomes achieved by AdoShell®? Islets in preclinical trials hold true promises for people with T1D. This technology could not only obviate the need for immunosuppressive but also ensure extended functionality, and outstanding biocompatibility. The potential of AdoShell®? Islet Islets could have a fundamental impact on the lives of millions of people living with diabetes and the way approach its treatment. AdoShell®? is committed to advancing the development of AdoShell®?, making it one of its strategic priorities. Adocia is actively working towards initiating clinical trials to bring this technology to patients as quickly and safely as possible. Adocia is preparing interactions with the EMA (European Medicines Agency) to validate the proposed development plan. AdoShell®?Islets could then be tested in clinics by the end of 2024. Preclinical data generated so far trigger interest from the scientific community and pharmaceutical industry. In parallel, AdoShell®? scaff old, as a technology platform, is being considered for applications with stem cells and in other therapeutic areas (Parkinson disease, hemophilia, oncology, etc.). The physical barrier formed by AdoShell®? allows the implanted cells to be invisible to the host's immune system while allowing the necessary physiological exchanges to occur for the survival and function of the islets. AdoShell®? Is lets is easily implantable through a minimally invasive surgery (laparoscopy) and is fullyretrievable. This biomaterial has demonstrated to be biocompatible and non-fibrotic. New Risk • Oct 20
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 63% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (21% average weekly change). Negative equity (-€18m). Shareholders have been substantially diluted in the past year (63% increase in shares outstanding). Reported Earnings • Sep 19
First half 2023 earnings released First half 2023 results: Revenue: €3.90m (down 63% from 1H 2022). Net loss: €9.39m (down 321% from profit in 1H 2022). Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 38% per year but the company’s share price has fallen by 2% per year, which means it is significantly lagging earnings. Annuncio • Jul 07
Adocia SA announced that it expects to receive €10 million in funding from Bpifrance Investissement SAS, Vester Finance SA and other investors Adocia SA announced a private placement of €10 million on July 5, 2023. The company will raise €5 million in common shares from Gérard Soula, Gérard Soula, Chairman of company Board of Directors, new investor Bpifrance Investissement SAS and in addition it will issue of €5 million in convertible bonds, to which new investor Vester Finance SA and European investors are investing in a single tranche. The company obtained the commitment of all investors for these two fund-raising operations, and they are working on their implementation. The conditions of these operations will be defined at a later date, in accordance with the resolutions approved at the last Annual General Meeting and will be the subject of an ad hoc communication as soon as they are finalized. Annuncio • Oct 06
Adocia Sa Announces Exceptional Weight Loss for Obese People with Type 1 Diabetes Using M1pram in A Post-Hoc Analysis Adocia SA announced outstanding additional results from its Phase 2 study with M1Pram in obese people with type 1 diabetes. Post-hoc analyses revealed the greater efficacy of M1Pram in a subpopulation of obese patients with a Body Mass Index (BMI) greater than 30kg/m2. Weight loss in the M1Pram arm was -5.56kg versus -0.57 kg (p=0.03) in the Humalog arm at week 16, and weight loss had not plateaued by the end of the study. The satisfaction questionnaire clearly demonstrated better appetite control with M1Pram for 82.4% of patients (versus 43.2% with Humalog). As a reminder, the CT041 Phase 2 clinical trial was comparing M1Pram to insulin lispro (Humalog®, Eli Lilly). The positive results on the total population were communicated on June 21, 2022. The study included people with type 1 diabetes and a body mass index greater than 25kg/m2 (overweight and obese people). The primary endpoint of the trial was met with a significant weight loss of M1Pram vs Humalog over 4 months of -2.13kg (p=0.0045). WHILE REDUCING WEIGHT, M1PRAM OFFERS GLYCEMIC CONTROL AS GOOD AS GOLD STANDARD MEALTIME INSULIN; M1Pram demonstrated to be equivalent to Humalog in controlling blood glucose, as safe in terms of risk of hypoglycemia and as convenient in terms of use. Both treatments maintain HbA1c levels and Time-In-Range in patients with a mean HbA1c level of 7.4% at baseline The number and severity of hypoglycemic events are similar in both treatment arms. This coformulation is injected at mealtime by single injection. In addition, M1Pram reduced the daily dose of prandial insulin by 21% in the general population of the study. M1Pram had an overall good safety profile. The difference in total adverse events of M1Pram versus Humalog (76 vs. 38) was mainly due to gastrointestinal side effects as documented in the pramlintide literature. OBESITY, A MAJOR BURDEN IN PEOPLE WITH TYPE 1 DIABETES AND AN UNMET MEDICAL NEED; Nine million people in the world currently suffer from type 1 diabetes and this figure will double in the coming years. 65% of them are overweight (BMI>25kg/m2) and about 37% are obese (BMI>30kg/m2) probably mainly due to the anabolic effect of insulin used daily to regulate diabetes. Moreover, emerging evidence suggests that obesity contributes to insulin resistance, dyslipidemia, and cardiometabolic complications in type 1 diabetes. To date, pramlintide is the only product reducing weight that is approved by the FDA as an adjunct to insulin for people with type 1 diabetes. M1PRAM TO REPLACE MEALTIME INSULINS FOR OBESE PEOPLE WITH DIABETES; M1Pram combines M1 insulin and pramlintide in a regular insulin pen. M1Pram coformulation is patented by Adocia until 2038. Pramlintide is an amylin analog that is FDA approved as an adjunct to insulin in type 1 and type 2 diabetes. Pramlintide has demonstrated having significant effects in improving glycemic control, weight loss in overweight patients and well-being. Despite its clinical benefits, pramlintide has never been largely used by patients because it requires 3 additional injections on top of insulin daily injections, these two hormones normally being incompatible in one formulation. Based on 15-years of experience in protein formulation and diabetes, Adocia has successfully formulated pramlintide and insulin together in one single pen. Reported Earnings • Sep 20
First half 2022 earnings released: EPS: €0 (vs €1.51 loss in 1H 2021) First half 2022 results: EPS: €0 (improved from €1.51 loss in 1H 2021). Revenue: €10.4m (up 312% from 1H 2021). Net income: €4.25m (up €14.9m from 1H 2021). Profit margin: 41% (up from net loss in 1H 2021). The move to profitability was primarily driven by higher revenue. Annuncio • Sep 07
ADOCIA Announces First Cell Therapy Preclinical Proof of Concept of AdoShell(R) Islets for the Treatment of Type 1 Diabetes Adocia announces the establishment of a first proof of concept for its' AdoShell Islets implant by achieving glycemic control without insulin injections in immunocompetent diabetic rats during the 132-day study. AdoShell Islets is an immuno-protective synthetic biomaterial containing islets of Langerhans. After implantation in diabetic animals, the islets encapsulated in AdoShell secrete insulin in response to blood glucose levels. The physical barrier formed by the AdoShell biomaterial allows the implanted cells to be invisible to the host's immune system while allowing the necessary physiological exchanges to occur for the survival and function of the islets. This study consisted of implanting islets from allogeneic rats (Wistar) - encapsulated in AdoShell -- into immunocompetent diabetic rats (Lewis). The insulin secreted by the transplanted islets was measured for 132 days and no slowing of secretion was observed during the duration of the study. At the end of the study the graft was removed, which resulted in an observable drop of insulin secretion and rise in blood sugar levels, the animals rapidly returned to its diabetic state. At the same time, the animals in the control group (diabetic rats that did not receive AdoShell Islets) were unable to control their blood sugar levels. Additional ongoing studies in diabetic rats, with the aim to optimize the AdoShell technology, confirm these initial results, producing insulin and normalizing the glycemia in 4 diabetic rats for 80 days (study still on-going). The weight gain of the studied rats - which is also an important clinical indicator of healthy test subjects - shows that the AdoShell Islets are performing as expected. In parallel the rats in the control group are not gaining weight as expected in diabetic rats. These results will be presented at the upcoming cell therapy session of the PODD 2022 conference held in Boston in October. Priority, treating life threatening cases with cells from donors More than 40 million people worldwide suffer from type 1 diabetes(1), also known as insulin-dependent diabetes: In these patients, the beta cells of the islets of Langerhans, cells that secrete insulin, are destroyed by an autoimmune mechanism. As a result, the patient survival depends on daily injections of insulin. Despite the use of insulin, some patients have intensely unstable diabetes characterized by extreme glycemic variability, responsible for iterative and/or severe unfelt hypoglycemia, altering the quality of life and increasing morbidity and mortality. The prognosis of this so-called "brittle" diabetes is poor, with a mortality rate between 20 to 50% over 5 years, depending on the study(2) . Brittle diabetes affects about 3 out of 1000 people with insulin-dependent diabetes, which represents 1000 patients in France and nearly 75 000 worldwide. Cell therapy techniques by replacing cells that have been destroyed exist and consist in injecting the patient with islets of Langerhans taken from pancreas of donors. These techniques are practiced in many countries and in 2020 the French High Authority for Health (the HAS) gave a favorable opinion on the registration of islets transplantation on the list of procedures that can be reimbursed by the public Health Insurance. However, this technique has a major pitfall because - like any allograft - islet transplantation as practiced to date requires the concomitant use of heavy immunosuppressive treatments to avoid rejection of the transplanted cells. These immunosuppressive protocols, whose undesirable effects are widely documented (hematological anomalies, infections, and neoplasia), limit the use of transplantation techniques to patients already under immunosuppressive treatment because they are also undergoing kidney transplantation. The first application of AdoShell Islets concerns the improvement of these techniques performed with donor pancreases and is precisely aimed at these so-called "brittle" patients so that they can benefit from them. A technology applicable to other cellular sources with the objective of treating the number of people In parallel with the development of AdoShell Islets from donor pancreases, Adocia also aims to develop its technology from stem cells, which would ultimately make this technology possible to free itself from the limit of the number of donors and thus treat a much larger number of patients. Annuncio • May 21
Adocia SA, Annual General Meeting, Jun 28, 2022 Adocia SA, Annual General Meeting, Jun 28, 2022, at 10:00 Central European Standard Time. Location: Hotel de Talleyrand, in the offices of Jones Day 2 rue Saint Florentin, 75001 Paris France Breakeven Date Change • May 19
Forecast breakeven date moved forward to 2022 The 2 analysts covering Adocia previously expected the company to break even in 2023. New consensus forecast suggests the company will make a profit of €12.6m in 2022. Annuncio • May 19
ADOCIA Announces First Subject Treated In BioChaperone® Combo Clinical Studies with Partner Tonghua Dongbao Adocia SA announced the first subject treated in the BioChaperone® Combo (“BC Combo”) CT046 clinical study. CT046 is one of the three clinical studies – together with CT047 and CT048 - financed by Tonghua Dongbao and conducted by Adocia in Germany. Final approval by the German (BfArM) regulatory authorities to conduct these studies has been communicated in a press release on 2022, April 11th. This program on BC Combo is part of the license to Tonghua Dongbao, signed in 2018. Under the terms of this agreement, Adocia received a $40 million upfront fee and is eligible for up to $50 million in milestone payments plus double-digit royalties on future sales of the product in China and other Tonghua Dongbao territories. Annuncio • May 10
Adocia Announces the First Patient Dosed in the BioChaperone® Lispro Phase 3 Program with Partner Tonghua Dongbao Adocia announced the dosing of the first patient with the BioChaperone® Lispro (“BC Lispro”) Phase 3 study. BC Lispro belongs to the last generation of Ultra-Rapid Insulins together with Fiasp® (Novo Nordisk®) and Lyumjev® (Eli Lilly®). The Phase 3 program consists of 2 studies treating people with type 1 and type 2 diabetes in 100 clinical centers across China and will enroll a total of c. 1300 patients. The aim of this program is to demonstrate safety and efficacy in comparison to standard of care (Humalog®). Results of this program will then be submitted to the Chinese Regulatory Authorities by Tonghua Dongbao to obtain marketing authorization. BC Lispro has been licensed-out to Tonghua Dongbao for China and major territories in Western Pacific and South-East Asia Regions that represents 200 million people suffering from diabetes1 and an estimated 20 million are using insulin every day for their survival.In 2018, the Chinese insulin market represented more than $3.5 billion2 and is forecasted to reach $5 billion2 in 2025 due to increased access to medicine, diagnosis, and prevalence of diabetes. BioChaperone® (BC) Lispro is an Ultra-Rapid Insulin obtained by combining Adocia’s proprietary BioChaperone technology to the rapid-acting market leader insulin lispro (as contained in the commercial product Humalog®). Being distributed more rapidly into the bloodstream than previous generations of insulins, BC Lispro reduces after-meal hyperglycemic excursions that are responsible for long-term comorbidities such as retinopathy, diabetic foot ulcer, kidney failure. Moreover, being eliminated faster from the body, BC Lispro may also reduce the risk of hypoglycemic events that are caused when insulin remains too long in the bloodstream after the post-meal hyperglycemia peak has declined. On top of its direct clinical benefits, the onset of action of BC Lispro results in improved quality of life with more dose-timing flexibility at mealtime. A mealtime injection, or even right-after-mealtime, enables patients to better determine the appropriate insulin dose as the exact timing and contents of their meal is known. This avoids overdosing or delayed dosing, which can lead to hypo- or hyperglycemia respectively, and prevent their severe short and long-term consequences. It significantly reduces the stress and the mental load of those affected by insulin-dependent diabetes and their caretakers which is important in day-to-day life. Currently, the only drugs providing similar effects in the world are Fiasp® of Novo Nordisk Co. and Lyumjev® of Eli Lilly and Company. Fiasp® and Lyumjev® are not currently available in China. BC Lispro was licensed to Tonghua Dongbao in 2018 in exchange for a $10 million upfront fee. The agreement also includes maximum payments of $35 million subjects to the achievement of future development milestones and double-digit royalties on sales to be paid to Adocia by Tonghua Dongbao. BC Lispro is patent protected until 2033. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 7 experienced directors. 5 highly experienced directors. Chairman of Diabetes Medical Advisory Board Jay Skyler was the last director to join the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Reported Earnings • Apr 21
Full year 2021 earnings released Full year 2021 results: Revenue: €6.06m (down 11% from FY 2020). Net loss: €22.8m (loss narrowed 2.4% from FY 2020). Over the next year, revenue is forecast to grow 577%, compared to a 43% growth forecast for the pharmaceuticals industry in Germany. Annuncio • Apr 12
Adocia SA Announces Start of 3 Clinical Studies for BioChaperone® Combo with Partner Tonghua Dongbao Adocia SA announced the final approval by the German (BfArM) regulatory authorities to conduct three clinical studies on BioChaperone® Combo. Tonghua Dongbao is financing the entire program which will be conducted by Adocia, with no impact on Adocia’s cash in hand. Adocia has demonstrated the clinical benefits of this new combination, notably the reduction of hyperglycemia and hypoglycemia compared to "premix" insulins (insulin with both a rapid-acting and long-acting profile), while maintaining the simplicity of use of a single injection. Annuncio • Dec 15
Adocia Files Patent for Technology to Enable Oral Drug Delivery of Peptides Adocia SA announced the filing of a patent for an oral delivery technology of peptides. Peptides and proteins are widely used as drugs, especially in the treatment of chronic diseases such as diabetes. However, almost all these drugs are only available in injectable dosage forms, which represents a burden for patients and limits the adoption of these products, especially in chronic diseases that require numerous and regular injections. In recent years, intense research efforts have focused on developing oral dosage forms. However, there are considerable technological challenges as peptides are not naturally absorbed in the digestive tract and undergo significant degradation before entering the bloodstream. Adocia has developed a formulation which has demonstrated through preclinical studies an enhancement of the efficiency of peptide absorption by the digestive tract, making it possible to switch from injectable to oral dosage forms. Reported Earnings • Sep 09
First half 2021 earnings released The company reported a soft first half result with weaker revenues and control over costs, although losses reduced. First half 2021 results: Revenue: €2.53m (down 29% from 1H 2020). Net loss: €10.6m (loss narrowed 11% from 1H 2020). Annuncio • Jun 30
Adocia Initiates BC LisPram Phase 1 Clinical Trial in Pump for People with Type 1 Diabetes Adocia announced the launch of a Phase 1 clinical study in collaboration with Dr. Ahmad Haidar, McGill University, Canada, to assess pharmacokinetic, glycemic control and safety of BioChaperone® Lispro Pramlintide (BC LisPram) prandial formulation in 16 people with type 1 diabetes compared to rapid insulin lispro. The medical benefits of pramlintide are scientifically demonstrated. Adding pramlintide to insulin improves glycemic control after a meal, induces weight loss, and induces a satiety effect. Pramlintide, despite being the only drug approved as an adjunct to insulin in type 1 diabetes, is underused as it requires three additional daily injections in addition to the multiple injections of insulin. Adocia has developed two products, M1Pram in pen for Multiple Daily Injection, currently in Phase 2, and now BC LisPram for insulin pump delivery. Adocia has confirmed the attributes of pramlintide in previous clinical trials with M1Pram. Annuncio • May 26
Adocia SA Expands Clinical Development to Obesity with Patent Applications on Short-Acting Multihormonal Combinations Administered by Pumps Adocia announced that three patent families have been filed for the treatment of metabolic diseases including obesity, NASH (Non-Alcoholic Steato-Hepatitis), type 2 diabetes and neurodegenerative disorders. These patents relate to combinations of short-acting hormones administered via pump. First preclinical results obtained in obese mice population by a combination of glucagon-exenatide (BioChaperone® GluExe) show a weight loss of 25% versus 15% with exenatide alone after 14 days of treatment1. A second combination of pramlintide and exenatide (PramExe), currently in development, also presents promising properties. The pumps used are those already marketed for insulin therapy, and in particular patch-pumps, which are easy to use and suitable for this purpose. The user can adjust the maximal tolerable dose and therefore optimize the benefit/risk balance. Adocia is offering a disruptive therapeutic approach by infusing short-acting hormones via a pump so that patients can easily and quickly adjust the doses administered, in contrast to the current way of thinking which is to extend the duration of action of hormones to offer weekly injections. One of the disadvantages of long-acting hormones is the impossibility to interrupt the side effects - particularly gastrointestinal - which can sometimes last several days after administration. Pharmaco-epidemiological studies on the use of once-weekly GLP-1 hormones in type 2 diabetes reveal that 48,0% of patients stop treatment after one year, while 73,2% stopped after two years. Reported Earnings • Apr 27
Full year 2020 earnings released: €3.35 loss per share (vs €2.68 loss in FY 2019) The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2020 results: Revenue: €6.83m (down 16% from FY 2019). Net loss: €23.3m (loss widened 25% from FY 2019). Products in clinical trials Phase I: 1 Phase II: 2 Phase III: 2 Over the last 3 years on average, earnings per share has fallen by 57% per year but the company’s share price has only fallen by 22% per year, which means it has not declined as severely as earnings. Reported Earnings • Mar 21
Full year 2020 earnings released: €3.30 loss per share (vs €2.68 loss in FY 2019) The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2020 results: Revenue: €6.83m (down 16% from FY 2019). Net loss: €23.3m (loss widened 25% from FY 2019). Over the last 3 years on average, earnings per share has fallen by 57% per year but the company’s share price has only fallen by 9% per year, which means it has not declined as severely as earnings. Annuncio • Mar 12
Adocia Initiates Phase 2 Clinical Trial for M1Pram in Patients with Type 1 Diabetes Adocia announced the initiation of a Phase 2 study in type 1 diabetes (T1D). The purpose of the study is to confirm and optimize the safety and efficacy of M1Pram in comparison with insulin lispro (Humalog®, Eli Lilly) in regard to glycemic control and body weight reduction. This study evaluates the efficacy of M1Pram on body weight reduction and blood glucose control compared to insulin lispro (Humalog®, Eli Lilly) after 16 weeks of treatment in 80 type 1 diabetes patients. Both products are administered in combination with basal insulin. Safety criteria are also being assessed. The study is designed as a multicentric, open-label, randomized, active-comparator controlled, two parallel arm trial. Glucose homeostasis is assessed using continuous blood glucose monitoring and patient satisfaction is appraised via a questionnaire. The study is conducted in Germany and has been approved by the German regulatory authority, the BfArM. In September 2020, its Phase 1b study results showed a statistically improved Time-In-Range for patients treated with M1Pram vs. aspart (Novolog®, NovoNordisk). Moreover, a significant average weight loss of 1.6 kg compared to baseline was observed in people treated with M1Pram. Patients treated with aspart observed an average weight gain of 0.4 kg. Additionally, after each treatment period, study participants completed a treatment satisfaction questionnaire. The data reflects the beneficial impact of M1Pram on individuals, 87% of them reported an improved appetite control, and 75% of the patients would recommend it to other people with diabetes. Annuncio • Jan 26
Adocia Announces Positive Clinical Results Confirming the Ultra-Rapid Profile of a BioChaperone® Lispro Formulation Containing Insulin from Partner Tonghua Dongbao Adocia announced positive results from a clinical pharmacology study comparing BioChaperone (BC) Lispro formulations employing insulin lispro from two different sources, a biosimilar from Tonghua Dongbao (THDB) and the brand, Humalog®, from Eli Lilly. This randomized, cross-over, double-blind, euglycemic clamp study was conducted on 30 people with type 1 diabetes. The study aimed to assess and compare the pharmacodynamic and pharmacokinetic properties as well as the safety of the four following formulations: BC Lispro (Adocia) composed of BioChaperone® and Tonghua Dongbao ’s insulin lispro. BC Lispro (Adocia) composed of BioChaperone® and the insulin lispro, Humalog® .Humalog® (Eli Lilly) approved in the USA. Humalog® (Eli Lilly) approved in Europe. Is New 90 Day High Low • Jan 12
New 90-day high: €10.10 The company is up 36% from its price of €7.41 on 14 October 2020. The German market is up 8.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 1.0% over the same period. Annuncio • Jan 12
Adocia Files Patent on a Hydrogel Scaffold for Cell Therapy in the Treatment of Type 1 Diabetes Adocia announced it is developing a hydrogel scaffold that hosts and protects pancreatic ß cells for replacement of the missing cells of people with type 1 diabetes. Among the 25 million people with type 1 diabetes in the world, and despite intensive and sophisticated insulin treatments, some patient’s diabetes are uncontrolled and should require pancreatic cell therapy to survive. Cell therapy consists of the administration of living cells to diabetic patients to restore glycemic control. Since the 1980’s, it has been possible to transplant Langerhans islets taken from the pancreas of a deceased donor. However, despite health authorities’ approval, this technique is restricted to a very limited population due to remaining issues: Scarcity of donors. The need for immunosuppressive drugs - to avoid the foreign cells to be rejected by immune system - is increasing the risk of infections and certain cancers. To solve these issues, Adocia has designed a new type of hydrogel scaffold able to host transplanted cells allowing them to release insulin while protecting them from immune reaction. Is New 90 Day High Low • Dec 17
New 90-day high: €8.36 The company is up 6.0% from its price of €7.85 on 18 September 2020. The German market is up 4.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 9.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €1.57 per share. Is New 90 Day High Low • Nov 30
New 90-day high: €8.22 The company is up 2.0% from its price of €8.03 on 01 September 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is down 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €1.49 per share. Is New 90 Day High Low • Oct 27
New 90-day low: €6.99 The company is down 13% from its price of €7.99 on 29 July 2020. The German market is down 4.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is down 14% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €1.03 per share. Is New 90 Day High Low • Sep 22
New 90-day low: €7.54 The company is down 11% from its price of €8.48 on 24 June 2020. The German market is up 5.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 8.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €1.01 per share. Annuncio • Sep 21
Adocia SA(ENXTPA:ADOC) dropped from S&P Global BMI Index Adocia SA(ENXTPA:ADOC) dropped from S&P Global BMI Index