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Corporate Presentation
March 2017
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Disclaimer Intro March 2017
This corporate presentation (the “Presentation”) has been prepared by ADOCIA (the “Company”) and is provided for information purposes only. It is not for promotional use. References herein to the Presentation shall mean and include this document, any oral presentation accompanying this document provided by the Company, any question and answer session following that oral presentation and any further information that may be made available in connection with the subject matter contained herein. The information and opinions contained in this document speak only as of the date of the Presentation and may be subject to significant changes. The Company does not undertake any obligation to update the information or opinions contained herein in light of any new information or future developments. The information contained in the Presentation has not been independently verified. No representation, warranty or undertaking, express or implied, is made as to the accuracy, completeness or appropriateness of the information and opinions contained in this document. The Company, its subsidiaries, its advisors and representatives accept no responsibility for and shall not be held liable for any loss or damage that may arise from the use of the Presentation or the information or opinions contained herein. The Presentation contains information on the Company’s markets and competitive position, and more specifically, on the size of its markets. This information has been drawn from various sources or from the Company’s own estimates. Investors should not base their investment decision on this information. The Presentation does not purport to contain comprehensive or complete information about the Company and is qualified in its entirety by the business, financial and other information that the Company is required to publish in accordance with the rules, regulations and practices applicable to companies listed on Euronext Paris. The Company’s annual reference document for the year ended December 31, 2015 filed with the French Autorité des marchés financiers (the “Financial Markets Authority”) on April 8, 2016 and available in an English convenience translation on the Company’s website, in particular its Risk Factors section found in Section 4, as well as any other of its periodic reports should be carefully reviewed. Information and other data appearing in such publications, and certain figures and numbers appearing in the Presentation have been rounded. Consequently, the total amounts and percentages appearing in tables and elsewhere may not necessarily equal the sum of the individually rounded figures, amounts or percentages. The Presentation contains certain forward-looking statements. These statements are not guarantees of the Company's future performance. These forward-looking statements relate to the Company's future prospects, developments and marketing strategy and are based on analyses of earnings forecasts and estimates of amounts not yet determinable. Forward-looking statements are subject to a variety of risks and uncertainties as they relate to future events and are dependent on circumstances that may or may not materialize in the future. Factors that may cause actual results to differ materially from those contained in any forward-looking statements include the uncertainties relating to research and development, results of clinical trials, success of the Company’s collaboration agreements and decisions by regulatory authorities regarding approval of the Company’s products, as well as those discussed or identified in the public filings made by the Company with the Financial Markets Authority. Forward-looking statements cannot, under any circumstance, be construed as a guarantee of the Company's future performance and the Company’s actual financial position, results and cash flow, as well as the trends in the sector in which the Company operates, may differ materially from those proposed or reflected in the forward-looking statements contained in the Presentation. Even if the Company’s financial position, results, cash-flows and developments in the sector in which the Company operates were to conform to the forward-looking statements contained in the Presentation, such results or developments cannot be construed as a reliable indication of the Company's future results or developments. The Company does not undertake any obligation to update or to confirm projections or estimates made by analysts or to make public any correction to any prospective information in order to reflect an event or circumstance that may occur after the date of the Presentation. The Presentation does not constitute an offer to sell or subscribe or a solicitation to purchase or subscribe for securities in France, the United States or any other jurisdiction. Securities may not be offered or sold in the United States absent registration under the US Securities Act of 1933, as amended, or an exemption from registration thereunder. No public offering of securities will be conducted in France or abroad prior to the delivery by the Financial Markets Authority of a visa on a prospectus that complies with the provisions of Directive 2003/71/CE as amended. No public offering of securities is contemplated in France or any jurisdiction outside France. The distribution of the Presentation may be restricted by law and persons into whose possession this document comes should inform themselves about, and observe, any such restrictions. All persons accessing the Presentation are deemed to agree to all the limitations and restrictions set out above. March 2017
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Management Team adocia Gérard Soula Olivier Soula Valérie Danaguezian
PhD, MBA Olivier Soula Valérie Danaguezian Rémi Soula Steve Daly President & CEO Co-founder Deputy General Manager, R&D Director Chief Financial Officer Director of BD & IP US General Manager March 2017
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ADOCIA in summary Adocia
1 Specialist in protein-based diabetes treatments, providing innovative therapeutic options 2 Business model based on already-approved proteins, enhanced with BioChaperone® 3 Phase 3 – ready ultra-rapid insulin BioChaperone Lispro 4 Strong pipeline with new clinical launches expected in 2017 5 Proven management team with successful track-record 6 Solid cash position March 2017
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Corporate Fact Sheet adocia
Focused on Diabetes treatment using already-approved therapeutic hormones to address core-defects: BioChaperone prandial insulins: BC Lispro (Phase 2) & HinsBet (Phase 2) BioChaperone Insulins Combo (Phase 2) New programs: BC Glucagon, BG Glargine GLP-1 combos, BC Lispro combos (preclinical) Founded in 2005 by Gérard, Olivier & Rémi Soula Listed on Euronext (ADOC) - Market Cap €142M*; Share Price: €20.70* (from IPO Feb 2012) Cash position end of December 2016 :€58M (€85M raised to date) Experienced executive team; 125 employees including 46 PhDs, MDs, PharmDs BioChaperone® unlocks the potential of hormones and their combinations Expanding treatment options by solving difficult formulations challenges 30 patent families ; validated in 15 human clinical trials to date March 2017 * As of Feb 10, 2017
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Our mission is dedicated to the treatment of diabetes
ADOCIA Our mission is dedicated to the treatment of diabetes Provide people with more physiologic treatments of diabetes in a simple and affordable way to help them avoid severe consequences of their disease March 2017
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Supported by a Top-Tier Medical Advisory Board
adocia Broad portfolio addresses the diverse medical needs of diabetes patient populations Clinical programs Preclinical programs In vitro PC Phase I/II Phase III In vitro PC Phase I/II BC Lispro U100 BC Glucagon BC Lispro U200 BC Gla Lira BC Gla Lispro BC Gla Dula (BC Combo) BC Lis Pram HinsBet U100 BC Lis Exe HinsBet U500 Supported by a Top-Tier Medical Advisory Board March 2017
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There remains a real medical need in diabetes
on insulin 415M1 people with diabetes in 2015 Despite 100 years of medical treatment, long-term consequences of diabetes remain a major issue People with T1D in particular, are still confined to insulin treatment ‘alone’ There is a need to address the underlying complexity of diabetes With more granularity In a simple way to ensure patient engagement 79%3 live with severe complications 1 International Diabetes Federation, Diabetes Atlas 2015; 2 Estimate based on 25% of diabetes patients having access to care, of which ~25% use insulin, as per Novo Nordisk, Full Year 2014 Investor presentation ; 3 Hazel- Fernandez & al; Am J Manag Care Patients with a Diabetes Complications Score Index of 1 or more, in a sample of 333,576 Medicare advantage plan members diagnosed with diabetes. March 2017
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DIABETES Sustainability of the healthcare systems raises a major cost-effectiveness challenge Need for sustainability of healthcare system, especially in pandemic disease like diabetes: Pressure on drug pricing Advent of biosimilar drugs Emergence of value-based models Volume will drive growth in the diabetes market Currently, millions of patients do not yet benefit from innovation due to cost hurdles $245B1 Diabetes -related costs (2012, US) $29B1 for antidiabetic drugs and supplies (12% of total, 2012, US) March 2017 1 American Diabetes Association, “Economic Costs of Diabetes in the US in 2012”, 2013.
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3 pillars support the future of diabetes treatment
Affordability Patient engagement More physiologic approaches Ultra-rapid insulin action Combo of synergistic hormones Synchronized hormonal actions Enable simple combinations Use of approved hormones vs. NCE Shorter clinical development March 2017
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[BioChaperone® Hormone]
adocia BioChaperone® unlocks the potential of hormones and their combinations in a cost-effective way BioChaperone® Hormones Simple formulation approach Leverage existing manufacturing capabilities Easy implementation 32 patent families On BC molecules and formulations 1st expiry date 2033 (insulin, GLP-1 RA, amylin, glucagon) (library of molecules) [BioChaperone® Hormone] Complex Accelerated absorption Improved solubility Improved stability Potential benefits March 2017
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Formulation enables affordable innovation
ADOCIA Formulation enables affordable innovation With BioChaperone®, Adocia develops innovative and cost-effective new treatments for diabetes Innovative formulation allows opportunity to improve and combine approved hormones with established track-records Enhance performance of individual hormones Enable combination of “un-combinable” hormones This approach to innovation has the following advantages: Reduced level of risk Shorter clinical development Lower investment levels (clinical and manufacturing) March 2017
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adocia Lean business model provides innovative treatments in a competitive landscape Adocia licensing business model targets diabetes players Early licensing opportunities allow for faster return on investment Adocia is evolving towards a more sustainable, higher-value licensing business model Shift from « proof-of-concept » to late-stage, Phase 3 ready projects Developing different risk-reward sharing strategies March 2017
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BioChaperone INSULIN Clinical programs
March 2017
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A more physiologic short-acting insulin for better outcomes
Bc lispro A more physiologic short-acting insulin for better outcomes BioChaperone® Lispro U100 Potential benefits $7B Prandial insulin market (2015)1 More time-in-range (less hypoglycemia and less hyperglycemia) More flexible dosing options at mealtime BioChaperone® Lispro U200 March 2017 1 Source: Adocia estimates based on major companies annual reports, 2015
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Faster BC Lispro improves glycemic control
Post-meal glycaemia in T1D Accelerated absorption and better post-prandial control for BC Lispro U100 vs. Humalog observed across T1D & T2D patients & devices BC Lispro U200 is the most advanced ultra-rapid concentrated insulin in development. Potential for co-filing with U100 BC Lispro has a complete dossier to enter into phase 3 Adocia is actively looking a potential partner AUC0-2h: -61%* Liquid meal + Insulin s.c. Trial in 38 subjects with type 1 diabetes (NCT# ) ; *CI-95% for LSM ratio These results were the subject of an oral presentation by Dr Tim Heise (Profil Neuss) during the 76th Scientific Sessions of the American Diabetes Association (June 2016). March 2017 For more detailed results, cf. Appendix
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Key clinical results supporting potential entry into Phase 3
Bc lispro Key clinical results supporting potential entry into Phase 3 Consistent results obtained in 210 people with T1D & T2D across common administration devices Repeated administration in T1D (solid meal test; March 14, 2016 ; NCT , 36 patients) 31% reduction in blood glucose excursion over first 2 hours vs. Humalog injected at mealtime at beginning of treatment 42% reduction at end of treatment Repeated administration in T2D (solid meal test; April 27, 2016; NCT , 51 patients) 22% reduction in blood glucose excursion over first 2 hours vs. Humalog injected at mealtime Insulin pump therapy in T1D (solid meal test; December 15, 2016; NCT , 44 patients) Acceleration demonstrated in 2 pumps & insulin syringe compared to Humalog injected at mealtime Pilot bioequivalence (BE) study U200/U100 (December 11, 2015; NCT , 26 volunteers) Predefined criteria for BE were met Study in healthy Japanese subjects (May 31, 2016; NCT , 15 patients) Confirmed BC Lispro PK/PD profile, allowing Japanese patients inclusion in Phase 3 March 2017
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Bc combo A true combination of two gold standard insulins - glargine as basal and lispro as prandial Once-a-day 6 10 14 18 22 2 Insulin lispro Humalog® 6 10 14 18 22 2 BioChaperone® COMBO = + Twice-a-day 6 10 14 18 22 2 Insulin glargine Lantus® 6 10 14 18 22 2 Schematic PK representations Twice-a-day vs. Premix insulin 6 10 14 18 22 2 March 2017
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BioChaperone® Gla Lispro
Bc combo Adocia is developing a simple 2-in-1 option for tight basal and prandial control $5B Premix insulin market (2015)1 Potential benefits* As simple as premix with better control and less hypoglycemia Less injections than Basal/Bolus with similar control One co-pay and use of “off-patent” insulins BioChaperone® Gla Lispro (BC Combo) *As demonstrated clinically by the only comparable approved product, Ryzodeg (Novo Nordisk) March 2017 1 Source: Adocia estimates based on major companies annual reports, 2015
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Bc combo T1D BC Combo has shown superior prandial and basal control compared to premix insulin in people with T1D Post-meal glycemia in T1D In T1D, BC Combo showed vs. HumalogMix 75/25: Less hyperglycemia (faster-acting) Less hypoglycemia (lower late prandial effect) Potential for once-a-day administration (24h basal action in a clamp trial) with most major meal coverage Individualized doses ∆AUC0-2h -24%1 Less hyper BGmin +30%2 Less hypo Liquid meal + Insulin s.c. Trial in 28 people with T1D (NCT# ); 1 p=3.10-3;2 p=8.10-3 These results were presented by Dr Steve Edelman (UCSD) during the 76th Scientific Sessions of the American Diabetes Association (June 2016). March 2017 For more detailed results, cf. Appendix
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Bc combo t2dm BC Combo 75/25 confirmed its promising profile compared to premix insulin in people with T2D Glucose Infusion Rate in T2D (clamp) BC Combo has the potential to offer competitive pricing compared to Novo Nordisk’s Ryzodeg® Program to achieve ready-to-phase 3 stage to reach next inflexion point 3 successful clinical studies (T1D & T2D) Ongoing meal-test study in T2D Results expected Q2 17 Planned dose-response study in T1D Expected to start Q2 17 Planned Outpatient study in T2D Expected to start Q4 17 Sharp transition Fast 24hr + Trial in 24 people with T2D (NCT# ). These results were the subject of poster commented by Dr Eda Cengiz (Yale School of Medicine) during the 76th Scientific Sessions of the American Diabetes Association (June 2016). March 2017 For more detailed results, cf. Appendix
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Human prandial insulin market (2015)1
hinsbet Adocia intends to deliver affordable prandial insulin to price-sensitive populations HinsBet® U100 Potential benefits Affordable prandial insulin Dosing closer to mealtime $1B Human prandial insulin market (2015)1 HinsBet® U500 March 2017 1 Source: Adocia estimates based on major companies annual reports, 2015
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Early Glucose Infusion Rate (U100)
hinsbet HinsBet displays similar early action to fast-acting insulin analog in T1D patients Early Glucose Infusion Rate (U100) Meal-test study in 36 T1D confirmed PD profile in first hour1 (Oct 2016) During first hour after the meal, HinsBet: Significantly reduced glucose excursion vs Humulin (p=0.0002) Was not significantly different from Humalog (p=0.5373) Exploring licensing options in emerging markets 1Meal-test study in 36 subjects with type 1 diabetes (NCT# ). Subjects received individualized single doses of HinsBet, regular human insulin (Humulin) and rapid-acting analog insulin lispro (Humalog) immediately before ingesting a standardized mixed meal. Detailed results remain under embargo until publication at a major diabetes conference. PK/PD clinical trial in 36 subjects with type 1 diabetes (NCT# ). March 2017
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New programs March 2017
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How to potentialize insulin action?
Multi- hormonal How to potentialize insulin action? GLP-1 Amylin In combination Insulin BC Glargine GLP-1 BC Lispro Pramlintide BC Lispro Exenatide Efficacy Glucagon In a dual-chamber pump Safety BC Glucagon + Insulin March 2017
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diabetes Among a multitude of metabolic hormones, 4 classes have been approved for the treatment of diabetes Pancreas Produces insulin, amylin & glucagon Multiple targets of action of: insulin amylin (pramlintide) GLP1 (GLP1-RA) glucagon Intestines Produce GLP-1 March 2017
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In T1D, hormonal pattern is severely disrupted
In healthy people, a time-sensitive hormonal pattern maintains normoglycemia diabetes Schematic representation of hormonal pattern1 Insulin Amylin Glucagon GLP-1 Meal Healthy Meal Insulin Amylin Glucagon GLP-1 With Type 1 diabetes (T1D) Level of secretion (relative scale) 1 2 3 4 5 6 1 2 3 4 5 6 Time Insulin, Amylin and GLP-1 are secreted X Glucagon is suppressed In T1D, hormonal pattern is severely disrupted 1 Source: Adocia, adapted from Toff-Neilsen et al, J. Clin Endocrinol Metab 2001;86: ; Cummings DE et al, Diabetes 2001;50: ; Aronoff SL et al , Diabetes Spectrum 2004; 17(3): March 2017
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People with T1D need multi-hormonal treatment to improve long-term outcomes
Bc prandial combos Complications1 heart disease, retinopathy, nephropathy, blindness, amputations… Industry focused on developing multi-hormonal treatments for T2D Established benefit of hormonal combinations in T2D T1D are insulin, amylin and GLP1-deficient Insulin alone is life-saving, but insufficient to prevent long-term complications despite optimal use Pramlintide is the only other hormone approved for T1D, but puts disproportionate burden on patients (up to 7+ injections/day total) No combination is approved for T1D Tighter glycemic control lowers the risk of severe complications1 65%2 of US adults with T1D are overweight or obese 36%3 of children with T1D are overweight or obese 1 DTTC study, NEJM, 1993, 329(14); EDIC study NEJM, 2005, 353(25) 2 Conway et al, Diabetes Med 2010 April; 27(4): BMI>25, Data for period. 3Du Bose et al, J Ped 2015, data for Germany & the USA, WHO BMI categories. March 2017
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Glucagon is needed to address hypoglycemia
Bc glucagon Glucagon is needed to address hypoglycemia Insulin prevents hyperglycemia (e.g. after meals) Glucagon prevents hypoglycemia (e.g. during exercise) by raising the blood glucose level Human glucagon is the only approved rescue treatment against severe hypoglycemia But human glucagon is unstable in solution requiring reconstitution of lyophilized product in emergency situations A ready-to-use aqueous solution of human glucagon is needed to improve treatment of hypoglycemia INSULIN Blood glucose concentration GLUCAGON March 2017
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BioChaperone® Human Glucagon DHAP : Dual-hormone artificial pancreas
Bc glucagon Adocia aims to greatly enhance insulin pump therapy with stable and soluble human glucagon CGM Insulin Glucagon * Potential benefits Relieve patient from risk of hypoglycemia, especially at night More time-in-range (less hypoglycemia & less hyperglycemia) More freedom to live “normal” everyday life BioChaperone® Human Glucagon DHAP : Dual-hormone artificial pancreas Automated administration of insulin and glucagon under continuous glucose monitoring (CGM) March 2017 * For illustration purposes only
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BC glucagon DHAP is a promising system to achieve truly automated closed-loop glycemic control 39 individual CGM traces (T1D) Insulin only (CSII) Bionic pancreas (DHAP) Significantly improved control with BetaBionics Ilet dual-chamber system (insulin + reconstituted Lilly Glucagon®) in pilot clinical study : Better glycemic control, less intrasubject and intersubject variability compared to usual care Less hypoglycemia than usual care Achieved in the home setting, meal announcements were optional. Device worn 24h/day for 11 days. March 2017 El Khatib et al, 77-OR, ADA 76th Scientific Sessions June 10-14th 2016, USA. Multicenter, randomized, CSII-controlled clinical trial in 39 adults with T1D. Russell et al, The Lancet (2016) 4(3):
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Adocia develops an aqueous human glucagon for use in a DHAP system
BC glucagon Adocia develops an aqueous human glucagon for use in a DHAP system Mean blood glucose (pigs) BC Human Glucagon showed similar action on blood glucose compared to Glucagen® during the first 3 hours in preclinical studies BC Human Glucagon is soluble and stable at pH 7 3 weeks stability at 37°C Development of standard concentration (1 mg/mL) for rescue and more concentrated formulations for DHAP First-in-man study expected to start in Q2 2017 N=7 pigs. Cross-over design BC Glucagon (1 mg/mL) vs. GlucaGen® (Novo Nordisk, 1 mg/mL, reconstituted ex-temporane.) March 2017
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BioChaperone® Glargine Dulaglutide BioChaperone® Glargine Liraglutide
BC Glar GLP-1 Adocia is developing efficient and affordable intensification options over basal insulin for T2D BioChaperone® Glargine Dulaglutide Potential benefits* Better control than basal alone Fewer side effects than each product separately Weight neutral Only 1 daily injection $7B Forecasted Basal-GLP1 market ( )1 BioChaperone® Glargine Liraglutide *As demonstrated clinically by approved products Xultophy® (IDegLira) & Soliqua® (IGlarLixi) March 2017 1 Source: Leerink forecasts, October 6, 2016
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Patients on basal insulin are not adequately controlled1
BC Glar GLP-1 Two injectable combos for better and/or more affordable intensification options in T2D 50%1 Patients on basal insulin are not adequately controlled1 Adocia is currently developing 2 products: BC Glargine Liraglutide, potential for competitive pricing, based on use of off-patent proteins BC Glargine Dulaglutide, potential for best-in-class performance, based on excellent profile of dulaglutide and glargine. First stability and preclinical results are promising First-in-man study expected on one product to start in , based on positive CMC & preclinical results Xultophy® (IDegLira, NVO) & Suliqua®/Soliqua® (IGlarLixi, SAN) approved in EU & US (2016) « All-in-1 » 1 product 1 injection 1 co-pay 1 Sanofi, JP Morgan Healthcare Conference Presentation , San Francisco, January 12, 2015. March 2017
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BioChaperone® Lispro Pramlintide BioChaperone® Lispro Exenatide
BC Lispro combos Enabling new prandial insulin combinations with already proven medical benefits BioChaperone® Lispro Pramlintide Potential benefits* Better control than prandial insulin alone Weight loss or weight neutrality Fewer side effects than each product separately No increase in injection burden BioChaperone® Lispro Exenatide *As demonstrated clinically by co-administration of approved products insulin & pramlintide in people with T1D and insulin & exenatide in people with T2D March 2017
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pramlintide Pramlintide (TID) clinically proven synergistic benefits with mealtime insulin in people with T1D Adocia intends to develop easy-to-use combinations of insulin/pramlintide for people with T1D Blood glucose control (T1D) -22%* -3 kg* Prandial suppression of glucagon Slowed gastric emptying Appetite reduction -0.2%* -0.2%* Guthrie R et al Diabetes 2005, 54(Suppl 1):A118 T1D, N = 265 at baseline; 6-month data; mean (SE); *: P <.05. See also Pullman J et al Vasc Health Risk Manag. 2006, 2 (3), and in T2D only: Karl D, et al. Diabetes Technol Ther 2007; 9(2): March 2017
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Delta glucose in blood after a mixed meal
exenatide Exenatide clinically proven synergistic benefits with mealtime insulin in people with T1D Delta glucose in blood after a mixed meal 150 100 50 -50 -100 200 300 Delta glucose (mg/dL) insulin insulin + exenatide 1.25µg insulin + exenatide 2.5µg Time (min) Exenatide on top of prandial insulin in T1D has shown: Improved glycemic control Insulin dose reduction of 20% GLP-1 have also demonstrated both in T1D and in T2D: Reduction in HbA1c after 6 months Weight loss compared to insulin alone Fewer side effects, especially hypoglycemia Adocia to develop easy-to-use combinations of insulin/GLP-1 for people with T1D Adapted from Raman VS, et al. Diabetes Care 2010 Jun; 33(6): Pediatric patients with T1D on MDI (N = 8) received BYETTA (exenatide) 1.25 and 2.5 mcg pre-meal adjunctive to prandial insulin. Glycaemia was analyzed for 6 hours post-meal. March 2017
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Unlocking the potential of prandial insulin combinations
BC Lispro combos unmixable Prandial Insulin (Lispro) Pramlintide or Exenatide Increases glucose disposal Modulate glucose appearance 3 injections/day 2 or 3 injections/day + BioChaperone BioChaperone Lispro Combos 3 injections/day or CSI March 2017
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BC Lispro Combos may restore the synergistic benefits of prandial hormones for people with T1D
BC Lispro Combos are potentially affordable options based on mature proteins: BioChaperone has demonstrated ability to stabilize these combinations in aqueous solution against fibrillation at 4°C and 37°C. BC Lispro Combos could be administered from a pen or a pump Pump use may mimic normal physiology even more closely Emerging T2D-friendly pumps may facilitate expanded use of BC Lispro Combos in T2D population Insulin lispro + Pramlintide Exenatide March 2017
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Key financial elements
adocia Key financial elements Financial summary Shareholders’ equity (November 30, 2016) Analysts Listed on Euronext Paris (ADOC) 6.9M shares outstanding ADR program in the US (ADOCY) Well capitalized €58M cash position (December 31, 2016) €85M raised since inception Long term debt: €0.9M loan from BPI France (refundable in case of success) €6.1M bank loan for purchase of Lyon headquarters building Soula Family 22.0 % Free Float (*) 60.3% BPI 10.8% Sham 4.7% Viveris 1.0% Oréo Finance 0.6% Key managers 0.6% Leerink (Seamus Fernandez) Jefferies (Peter Welford) Kepler Market (Arsène Guekam) Invest Securities (Martial Descoutures) Oddo (Sébatien Malafosse – Pierre Corby) Louis Capital Partners (Pierre Vaurice) (*) including US investors from March, 2015 private placement of 10% of the capital (KKR, Alken, BVF and others) March 2017
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Expected upcoming catalysts
adocia Expected upcoming catalysts Clinical programs Preclinical programs BC LISPRO Phase 3-ready asset to be partnered BC COMBO Ongoing Phase 2a study in T2D results : Q2 17 Planned dose-response study in T1D: to start Q2 17 Planned outpatient study in T2D: to start Q4 17 HINSBET Looking for a partner in regional markets BC HUMAN GLUCAGON First-in-man study : Q2 2017 BC GLARGINE DULA & BC GLARGINE LIRA First-in-man study : 2017 BC LISPRO PRAMLINTIDE & BC LISPRO EXENATIDE First-in-man study : Q4 17 March 2017
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appendix March 2017
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Adocia is supported by a top-tier Medical Advisory Board
12 highly renowned international thought-leaders: Dr. Jay Skyler, MD, Chairman, University of Miami (US) Dr. Vanita Aroda, MD, MedStar Health Research Institute (US) Dr. Bruce Bode, MD, Emory University (US) Dr. John Buse, MD, PhD, University of North Carolina (US) Dr. William Cefalu, MD, Louisiana State University (US) Dr. Steven V. Edelman, MD, University of California at San Diego (US) Dr. Dan Einhorn, MD, University of California at San Diego (US) Dr. Vivian Fonseca, MD, Tulane University (US) Dr. Irl Hirsch, MD, University of Washington (US) Dr. Chantal Mathieu, MD, University Hospital of Leuven (Belgium) Dr. Thomas Pieber, MD, Medical University of Graz (Austria) Prof. Denis Raccah, MD, PhD, APHM (France) March 2017
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Results summary compared to Humalog U100 in T1DM subjects
Bc lispro Results summary compared to Humalog U100 in T1DM subjects 294-OR in Novel Therapeutics in T1D, June 13, 2016, 76th ADA Scientific Sessions BioChaperone Lispro in comparison with Humalog showed: Faster absorption Faster-in (Early t[50%max], tmax, AUC0-30min) Faster-out (Late t[50%max], AUC2- 8h) Similar total exposure Reduced post prandial glucose excursions 61% PPG reduction over the first two hours Reduction of blood glucose by 42 mg/dL at 1 hour Similar safety profile at single dose conditions based on local tolerance and number of hypoglycemic events Comprehensive work to further evaluate BioChaperone Lispro ongoing, including a concentrated U200 formulation Biochaperone Lispro: Shorter TMAX, Higher CMAX and Similar Exposure Greater Earlier Exposure: Faster In GeoLSM BC Lispro GeoLSM Humalog Ratio [95%CI] BC Lispro/Humalog Early t[50%max] (min) 18 29 0.63 [0.57; 0.70] AUC0-30min (h*mU/L) 23 9 2.68 [2.18; 3.30] AUC0-1h (h*mU/L) 76 50 1.52 [1.37; 1.67] GeoLSM BC Lispro GeoLSM Humalog Ratio [95%CI] BC Lispro/Humalog Tmax (min) 47 62 0.75 [0.69; 0.83] Cmax (mU/L) 117 104 1.13 [1.06; 1.20] AUC0-8h (h*mU/L) 256 254 1.01 [0.97; 1.05] Lower Late Exposure: Faster Out Better Post Prandial Glucose Control GeoLSM BC Lispro GeoLSM Humalog Ratio [95%CI] BC Lispro/Humalog Late t[50%max] (min) 135 160 0.85 [0.78; 0.91] AUC2-8h (h*mU/L) 84 106 0.79 [ 0.72; 0.87] BC Lispro Humalog Mean Difference BG1h (mg/dL) 135 177 42 BG2h (mg/dL) 126 153 27 March 2017
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Bc COMBO Results summary compared to Conventional Lispro Mix 75/25 in T1DM subjects 295-OR in Novel Therapeutics in T1D, June 13, 2016, 76th ADA Scientific Sessions In this solid mixed meal study, BC Combo achieved more effective PPG control than lispro Mix: Improved post-prandial blood glucose control 24% reduction in ΔAUCBG_0-2h 23 mg/dL decrease in maximum BG 24 mg/dL mean BG reduction at 1hr Lower risk for delayed prandial hypoglycaemia Less subjects with low BG < 63 mg/dL and 50 mg/dL Less time spent in hypoglycaemia and more time spent in target glycaemia Potential of BC Combo to improve post- prandial glucose control and lower risk of both hyperglycaemic and hypoglycaemic excursions will be investigated in further clinical studies Mean Unadjusted BG Profiles ± SEM Over 6hr After s.c. Administration of Individualised Doses of BC Combo and Lispro Mix Cumulative Percentage of Subjects With BG Values < 63 mg/dL (A) or < 50 mg/mL (B) Over the Course of the Meal Test Demographic and Baseline Characteristics of the Study Population Hypoglycaemic events Parameter Mean ± SD Sex Female: n-6 (21.4%) Male: n-22 (78.6%) Diabetes Duration (years) 27.2 ± 11.5 Race White 100% BMI (kg/m2) 24.2 ± 2.1 Age (years) 45.9 ± 11.2 C-Peptide (nmol/L) Height (cm) 177 ± 8 HbA1c (%) 7.33 ± 0.80 Weight (kg) 76 ± 10 Parameter BC Combo Lispro Mix P-value Subjects with at least one hypoglycaemic event 7 / 27 15 / 28 Number of hypoglycaemic events 12 29 event per subject 02 30 subjects screened, 28 randomised, 28 received lisproMix – 27 received BC Combo Full analysis set n=28: 27 BC Combo – 27 lispro Mix (1 exclusion due to wrong dosing) 1 Chi-Square test 2 Median 3 Wilcoxon Signed Rank test March 2017
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Results summary compared to Humalog 75/25 in T2DM subjects
Bc COMBO Results summary compared to Humalog 75/25 in T2DM subjects 942-P in 12-B Clinical Therapeutics/ New Technology-Insulins, June 11, 2016, 76th ADA Scientific Sessions In this study, BC Combo demonstrated: Greater early glucodynamic effect in first hour post dosing and faster time to maximum blood glucose lowering which is essential to achieve better post prandial blood glucose control Lower late post prandial effect in comparison to Humalog Mix 75/25 which may reduce the risk of delayed post- prandial hypoglycaemia as shown in a meal test study in subjects with T1DM (ADA OR-295) Higher late basal effect than Humalog Mix 75/25, similar to the separate injections, indicating that BC Combo could adequately provide both basal and prandial insulin requirements for a meal with only one injection per day The results obtained in T2DM subjects replicate our findings in subjects with T1DM by demonstrating BC Combo’s favorable time-action profile over Humalog Mix 75/25 Smoothed GIR Profiles (0-30h) of 0.8 U/kg BioChaperone Combo, U/kg HumalogMix 75/25 and Separate Injections of 0.2 U/kg Lispro U/kg Glargine Smoothed GIR Profiles (0-2h) of 0.8 U/kg BioChaperone Combo, 0.8 U/kg HumalogMix 75/25 and Separate Injections of U/kg Lispro U/kg Glargine PD Parameters Based on Glucose Infusion Rate BC Combo Humalog Mix 75/25 P-value vs. BC Combo Lispro _ glargine Pramdial Phase (0.6h) AUCGIR 0-1h [mg/kg] 88 (74) 29 (34) <0.0001 58 (48) 0.0087 AUCGIR 0-2h [mg/kg] 294 (227) 174 (126) 0.0001 277 (184) 0.5227 AUCGIR 0-6h [mg/kg] 860 (536) 1011 (535) 0.0335 1121 (556) 0.0003 TGIRmax [h] 1.3 [1.2;5.1] 3.8 [1.8;6.0] 2.9 [1.4;4.9] 0.0057 Prandial – Basal Transition (6-12h) AUCGIR 6-12h [mg/kg] 589 (275) 870 (501) 0.0002 630 (211) 0.3420 AUCGIR 6-24h [mg/kg] 1075 (615) 1481 (911) 1156 (551) 0.4522 Basal Phase (12-30h) AUCGIR 12-18h [mg/kg] 342 (225) 473 (354) 0.0063 382 (221) 0.2156 AUCGIR 24-30h [mg/kg] 186 (133) 99 (102) 0.0105 174 (139) 0.6747 Overall AUCGIR 0-30h [mg/kg] 2122 (1184) 2590 (1368) 0.0103 2451 (1071) 0.0124 Table shows arithmetic means (SD) except median [min;max] for TGIRmax P-value from Hodges and Lehmann Estimates or (for AUCGIR 0-6h and AUCGIR 0-30h) from LS Means March 2017
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March 2017
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