Adocia Sa · EURONEXT:ADOC
Adocia Sa — Investor Presentation (November 2022)
49 slides from Adocia Sa's investor presentation, November 2022
Slide 1: Corporate Presentation November 2022
Corporate Presentation November 2022
Slide 2: Disclaimer
Disclaimer This corporate presentation (the “Presentation”) has The Presentation does not purport to contain well as the trends in the sector in which the Group been prepared by ADOCIA S.A. (the “Company” and, comprehensive or complete information about the operates, may differ materially from those
Slide 3: Highly experienced management team
Highly experienced management team Gérard Soula Olivier Soula Valérie PhD, MBA PhD, MBA Danaguézian Deputy General Manager, President & CEO R&D Director Chief Financial Officer Co-founder Co-founder Jérémy Benattar Michael PharmD, Eng Nguyen Director of Marketing & Head of BD,US Strategy • Co-founde
Slide 4: Executive Summary
Executive Summary Our mission: development of innovative formulations of approved 1 peptide and cell treatments for diabetes and obesity Our projects are based on 4 proprietary technologies: BioChaperone®, 2 AdOral®, AdoShell® and AdoGel®, with 4 products in clinical trials Business model: Licensing
Slide 5: A diversified specialty products pipeline
A diversified specialty products pipeline Preclinic Phase 1 Phase 2 Phase 3 Status / Upcoming milestones Phase 3 in China ongoing BC Lispro Partnered Ultra-Rapid Insulin Phase 3 in USA and Europe U100 / U200 for Asia ready to start* Insulins Combination BC Combo Partnered Phase 1 ongoing Long acting
Slide 6: Business Strategy: a solid partnership and promising projects
Business Strategy: a solid parnership and promising projects Partnered Products: Partnership with Tonghua Dongbao Supporting THDB, Milestones (80M$) + BC Lispro and BC Combo royalties to be received M1Pram AdoShell Islets Proprietary Products to BC Lispro UE/US be licensed: POC established in Precli
Slide 7: Partnering models based on proprietary technology platforms with strong IP
Both Adocia’s partnering models are based on proprietary technology platforms with strong IP strategy BioChaperone® AdOral® AdoShell® AdoGel® • Pharmaceutical excipient • Pharmaceutical excipient • Hydrogel scaffold • Hydrogel • Forms a complex with • Enhances proteins/peptides • Encapsulation of ce
Slide 8: Diabetes and Obesity: worldwide chronic pandemics
Diabetes and Obesity: worldwide chronic pandemics 537 million people live with diabetes1 Diabetes is closely linked to obesity 1 in 11 • In the US, 65% of adults with type 13 diabetes and 85% of type 24 are overweight or obese • Several hormones are involved in both diabetes and obesity 1.9 billion
Slide 9: Proprietary specialty products based on approved drugs
Proprietary specialty products based on approved drugs 9 9
Slide 10: BioChaperone Lispro
BioChaperone® Lispro Best-in-class Rapid Acting Insulin for a tighter glycemic control 10 10
Slide 11: BC Lispro has competitive advantages in the Ultra-Rapid Insulin class
BC Lispro has competitive advantages in the new Ultra-Rapid Insulin class Post-meal glycaemia in T1D • Better efficacy profile for less hyperglycemia and less hypoglycemia (“Faster-in” / “Faster- out”) vs. comparators AUC0-2h: -61%* • Good tolerance for optimized daily use • Range of strengths (U100
Slide 12: BC Lispro in phase 3 program in China with Tonghua Dongbao
BC Lispro in phase 3 program in China with Tonghua Dongbao Market • Prandial insulin WW market $8bn1 • Sales of insulin and analogues in China’s public medical institutions c. $4 billion in 2020 Partnership with Tonghua Dongbao (2018) • Licensed for development & commercialization for China and othe
Slide 13: BC Combo, glargine-lispro premix
BC Combo, glargine-lispro premix The best insulin premix 13 13
Slide 14: BC Combo, a unique combination of glargine and lispro
BC Combo, a unique combination of glargine and lispro, the gold standards of basal and prandial insulins BioChaperone® Combo 1 product Once or twice a day U200 fixed ratio (150 U/mL glargine - 50 U/mL lispro) Less hyperglycemia Simple Affordable Less hypoglycemia Limited number of injections
Slide 15: BC Combo is licensed to Tonghua Dongbao in China
BC Combo is licensed to Tonghua Dongbao in China Premix market Tonghua Dongbao deal $2.7bn1 Western Markets: T2D patients • $40m upfront $2.3bn1 • $50m upcoming development Emerging Markets: milestones T1D & T2D • Double-digit royalties on sales ~65% patients Market share in India and China (volume)
Slide 16: Insulin & Amylin analogs combinations M1Pram and BC LisPram
Insulin & Amylin analogs combinations M1Pram and BC LisPram First-in-class combination products, the 5th generation of prandial insulin 16 16
Slide 17: Amylin hormone is missing in people with diabetes
Amylin hormone is missing in people with diabetes, and it contributes to diabetes dysregulations Meal Pancreas Insulin Normal pattern Level of secretion (relative scale) Amylin Insulin Glucagon Secreted 0 1 2 3 4 5 6 Co-secreted Glucagon by α-cells Time (hours) by β-cells Meal Level of secretion Glu
Slide 18: Pramlintide (Symlin), an amylin analog, has demonstrated clinical benefits
Pramlintide (Symlin®), an amylin analog, has demonstrated its clinical benefits when associated with insulin and is FDA approved in T1D and T2D Pramlintide pharmacological effects Symlin limitations 1. Activates amylin receptors in different brain areas 1. 3 additional daily injections required on t
Slide 19: Improving insulin therapy by multi-hormonal combination
Adocia targets to improve insulin therapy by multi-hormonal combination Medical benefits Multi-hormonal combinations M1Pram, BC LisPram Ultra-Rapid Insulins BC Lispro, Fiasp®, Lyumjev® Insuline-Pramlintide combination is the first solution able to improve: Rapid Acting Insulins Humalog®, Novolog®
Slide 20: One formulation for pen and one for pump
Adocia is developing one formulation for pen and one for pump Type Preclinic Phase 1 Phase 2 Phase 3 Regular insulin Clinical + Pramlintide M1Pram POC in Pen (MDI) Rapid insulin End of Q4 2022 + Pramlintide BC LisPram Phase 1 T1D pump study results in Pump MDI: Multiple Daily Injection M1: A21G huma
Slide 21: M1Pram reduces body weight with high efficacy in T1D with obesity
M1Pram reduces body weight with high efficacy in T1D with obesity CT041 : Phase 2 study – M1Pram vs. lispro (Humalog®) - type 1 diabetes - 16 weeks ambulatory Body Weight Change from Baseline to Week 16 All patients BMI ≥ 25 kg/m² BMI ≥ 30 kg/m2 (p value = 0.001) (post hoc, p value = 0.03) Mean +/-
Slide 22: Maintained glycemic control, with 21% reduction in prandial insulin dose
Maintained glycemic control, with 21% reduction in prandial insulin dose Change from baseline* Mean (SD) P-value M1Pram Lispro HbA1c (%) 0.14 (0.51) 0.10 (0.51) 0.81 (NS) Time-In-Range 70-180 mg/dL (%) -3.17 (8.76) -1.54 (8.87) 0.29 (NS) Prandial insulin dose (U/d) -5.97(6.18) -0.61(7.08) <0.001 Whi
Slide 23: Medical value of M1Pram insulin pramlintide combination is confirmed
Medical value of M1Pram insulin pramlintide combination is confirmed Significant weight loss is demonstrated • Strong effect in T1D patients with obesity Satiety effect is induced Sparing effect on prandial insulin dose Product is well tolerated and safe Glycemic control is maintained with
Slide 24: M1Pram in pen generates high expectations from KOLs
M1Pram in pen generates high expectations from KOLs “The phase 2 study of M1Pram shows that a single injection with “The glycemic results with M1Pram (P1b) are each meal is as easy to use and as efficient as Humalog for quite promising as is the observed weight loss, glycemic control without increas
Slide 25: BC LisPram: the optimal combination for pumps
BC LisPram: the optimal combination for pumps Clinical Proof-of-Concept established at Mc Gill University, Canada, Adocia intends to reproduce A. Haidar POC with its fixed by Dr. Ahmad Haidar combination of Lispro and Pram delivered in one single pump Lispro in one pump vs. Lispro and Pramlintide ad
Slide 26: AdoShell islets to cure Type 1 Diabetes
AdoShell® islets to cure Type 1 Diabetes Immuno-protective scaffold for pancreatic islet transplant 26 26
Slide 27: Adocia's vision: from hormonal to cell therapies
Adocia’s vision of metabolic diseases treatment: from hormonal to cell therapies Immuno-protective scaffold for islets of Langerhans Oral Delivery of hormones Pluri-hormonal formulations Improved proteins/peptides formulations Adocia is taking on high challenges, that require innovative mindset and
Slide 28: Islets transplantation has changed lives but still has limitations
Islets transplantation has changed lives of patients living with brittle T1D but still suffering from many limitations Among 40 million people live with T1D worldwide, 75 000 T1D are particularly unstable • Life expectancy 27- to 45-year-old • Approx. 1000 cases in France (3 T1D unstable/1000 T1D)
Slide 29: AdoShell, an immuno-protective scaffold for islets transplantation
Adocia has developed AdoShell®, an immuno-protective scaffold for islets of Langerhans transplantation for brittle diabetes Hydrogel Reagents Immuno-isolation AdoShell-Islets Film Ab, T cells Large entities > 10 nm + Insulin secreting cells 1st generation: Langerhans islets from deceased donors 2nd
Slide 30: AdoShell: ultra-thin, immuno-protective hydrogel film for cell encapsulation
AdoShell® : An ultra-thin, immuno-protective hydrogel film for cell encapsulation High water content for cell compatibility Immuno-isolating gel Ultra-thin aseptic film High cell density for miniaturization Biocompatible Mechanically resistant Implantable by mini-invasive surgery Retri
Slide 31: POC in diabetic rat: glycemia controlled during 132-day study
POC in diabetic rat: glycemia controlled during a 132-day study without immunosuppressor 1. Transplantation of AdoShell containing allogenic islets in diabetic rat peritoneum at day 0. Comparison to negative control (empty AdoShell). 2. Explantation of the implant AdoShell islets at day 132. Sacrifi
Slide 32: Development is in progress
Development is in progress In vitro encapsulation results Human islets viable and functional Fast insulin delivery to glucose stimuli No infiltration of antibodies Simple aseptic and cell-friendly process In vivo transplantation results Control of the glycemia in diabetic rat for 132 days
Slide 33: AdOral
AdOral® A promising technology for oral delivery of peptides 33 33
Slide 34: Only 5 peptide therapeutics approved for oral delivery in a growing market
Only 5 peptide therapeutics have been approved for oral delivery in a growing market dominated by injectable forms Global Peptide Therapeutics Market* ($) *mAb excluded from the analysis Cyclosporin 39 Billion 48 Billion 1.2 kDa Approved 1995 Voclosporin Octreotide 50 Desmopressin 1.2 kDa 1.0 kDa GL
Slide 35: AdOral: a promising technology for oral delivery of peptides
AdOral: a promising technology for oral delivery of peptides AdOral is a unique formulation based on a new type of permeation enhancer (PE)* combined with peptide protection against degradation AdOral form is a tablet or capsule Technology patented by Adocia The technology has been validated with Se
Slide 36: Semaglutide with AdOral shows improved bioavailability in animal
Semaglutide formulated with AdOral has shown significantly improved bioavailability in animal Median Semaglutide PK Profile (N=10) 250 1, 242.5 1.5, 226.5 2, 226.5 0.75, 214.5 3, 215 200 5, 196.5 150 Bioavailability of semagludide 0.5, 117.15 Rybelsus® formulated with AdOral: 100 AdOral - semaglutid
Slide 37: Obesity
Obesity Personalized multi-hormonal obesity treatment: a new paradigm “At Adocia, we believe that long lasting victory against obesity will come from the patients – so let’s give them the tools they need” 37 37
Slide 38: Obesity, new therapies for a worldwide chronic pandemic
Obesity, new therapies for a worldwide chronic pandemic • 650 million adults are obese Recent therapeutic breakthroughs 1. Short acting GLP-1, Liraglutide • 1.9 billion are overweight (Saxenda® , Novo) 2. Long acting GLP-1, Semaglutide • Of the 42.4% Americans who are obese, (Wegovy®, Novo) up to 70
Slide 39: Patient-centric treatments with short-acting hormones delivered by a pump
Adocia is developing patient-centric treatments with short-acting hormones delivered by a pump DRUG-DEVICE COMBINATION « STOP-AND-GO » CONCEPT n days infusion n days infusion 1 day off Concentration The patient wears a patch-pump 4x to deliver combination of short acting hormones Concentration Expec
Slide 40: Combinations of diabetes hormones to treat obesity
Combinations of “diabetes” hormones appear to be a revolutionary way to treat obesity Weight loss %* 0 Current marketed AMYLIN treatments 5 Diabetes GLP-1 Obesity Mono-hormonal 15 GLUCAGON 20 Multi-hormonal Time Adocia has selected a combination of Glucagon and Exenatide, two hormones with different
Slide 41: BioChaperone Glucagon Exenatide (BC GluExe)
BioChaperone® Glucagon Exenatide (BC GluExe) Proof-of-Concept established in obese mice 120 110 100 Saline (vehicle) BC Exenatide* Exenatide “standalone” showed a significant 90 -10% Exenatide -10% weight loss compared to vehicle BW (%) 80 70 -25% BC Glucagon Exenatide*** showed a significant -25% w
Slide 42: AdoGel, Long-acting Drug Delivery Platform
AdoGel®, Long-acting Drug Delivery Platform 42 42
Slide 43: AdoGel, a hydrogel for long-acting drug delivery
AdoGel, a hydrogel for long-acting drug delivery • Adocia is developing a soft tissue-like biomaterial for sustained release of small molecules/ biologics • Pharmaceutic forms • Implantable & Removable device • Injectable (in-situ forming gel) Implantable device Injection and in-situ forming gel • M
Slide 44: Sustained release of Levonorgestrel over 80 days in rats
First application : Sustained release of Levonorgestrel (LNG) over 80 days after SC administration in rats Ongoing study 6 Mean (±SE) PK profile in rats 20 Cumulative absorption in rats 5 79.999998,15.488 15.71 79.919998, 79.839998, 79.759998, 79.679998, 79.599998, 79.519998, 79.439998, 79.359998, 7
Slide 45: Financial & news flow
Financial & news flow vin ADOCIA f-
Slide 46: News flow
News flow BC Lispro M1Pram AdoShell® Islets • First-in-human study expected in • In China (with partner THDB): • Additional Phase 2 study, 2023 Phase 3 ongoing under partnering condition AdoGel® • In USA/EU: Phase 3 ready to be BC LisPram • Preclinical Proof of Concept launched upon partnership resu
Slide 47: Key financials & shareholder information
Key financials & shareholder information, as of September 30, 2022 Key financials features Shareholder ownership Market information Already received • Listed on Euronext Paris (ADOC) • €85m raised since inception • 8.3m shares outstanding • $125m received from partnerships • ADR program in the US (A
Slide 48: Summary
Summary • Adocia’s projects are based on 4 proprietary technologies: BioChaperone®, AdOral®, AdoShell®, AdoGel® • A well-advanced and diversified pipeline with products ready-to-license: • 4 products in ongoing clinical trials: o BC Lispro Phase 3 clinical trial in China o BC Combo clinical trials f
Slide 49: Thank you for your kind interest
Thank you for your kind interest 115 avenue Lacassagne 69003 Lyon – FRANCE Ph.:+33 4 72 610 610 [email protected]