CORPORATE PRESENTATIONMARCH 2017

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March 2017 2

INTRO

Management Team

March 2017 3

ADOCIA

Gérard SoulaPhD, MBA

Olivier Soula PhD, MBA

Valérie Danaguezian Rémi SoulaPhD, MBA

Steve Daly

President & CEOCo-founder

Deputy General Manager, R&D DirectorCo-founder

Chief Financial Officer Director of BD & IPCo-founder

US General Manager

ADOCIA in summary

March 2017 4

ADOCIA

Specialist in protein-based diabetes treatments, providing innovative therapeutic options

1

Business model based on already-approved proteins, enhanced with BioChaperone®2

Phase 3 – ready ultra-rapid insulin BioChaperone Lispro 3

Strong pipeline with new clinical launches expected in 20174

Proven management team with successful track-record5

Solid cash position6

Corporate Fact Sheet

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 €15.90 @ 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 5

ADOCIA

* As of Feb 10, 2017

Our mission is dedicated to the treatment of diabetes

March 2017 6

ADOCIA

Provide people with more physiologic treatments of diabetes

in a simple and affordable way

to help them avoid severe consequences of their disease

Broad portfolio addresses the diverse medical needs of diabetes patient populations

March 2017 7

ADOCIA

Clinical programs Preclinical programs

BC Lispro U100BC Lispro U200BC Gla Lispro

HinsBet U100HinsBet U500

BC Glucagon

BC Lis Pram

BC Gla LiraBC Gla Dula

In vitro

PC Phase I/II Phase III

BC Lis Exe

In vitro PC Phase I/II

(BC Combo)

Supported by a Top-Tier Medical Advisory Board

There remains a real medical need in diabetes

March 2017 8

DIABETES

79%3 live with severe

complications

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

415M1

people with diabetes in

2015

26M2 on insulin

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. 2015. Patients with a Diabetes Complications Score Index of 1 or more, in a sample of 333,576 Medicare advantage plan members diagnosed with diabetes.

Sustainability of the healthcare systems raises a major cost-effectiveness challenge

March 2017 9

DIABETES

1 American Diabetes Association, “Economic Costs of Diabetes in the US in 2012”, 2013.

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

$29B1 for

antidiabetic drugs and supplies (12% of

total, 2012, US)

$245B1

Diabetes -related costs (2012, US)

3 pillars support the future of diabetes treatment

March 2017 10

DIABETES

Affordability

Patient engagement

More physiologicapproaches Ultra-rapid insulin action

Combo of synergistic hormones

Synchronized hormonal actions

Enable simple combinations Use of approved

hormones vs. NCE Shorter clinical

development

BioChaperone® unlocks the potential of hormones and their combinations in a cost-effective way

March 2017 11

ADOCIA

[BioChaperone® Hormone]Complex

(library of molecules)

BioChaperone®

Accelerat

ed absorptio

n

Improved solubility

Improved stability

Hormones(insulin, GLP-1 RA, amylin, glucagon)

Simple formulation approach Leverage existing

manufacturing capabilities

Easy implementation

32 patent families On BC molecules and

formulations 1st expiry date 2033Potential

benefits

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 12

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 13

ADOCIA

BIOCHAPERONE INSULIN CLINICAL PROGRAMS

March 2017 14

A more physiologic short-acting insulin for better outcomes

March 2017 15

BC LISPRO

More time-in-range (less hypoglycemia and less hyperglycemia)

More flexible dosing options at mealtime

Potential benefitsBioChaperone® Lispro U100

BioChaperone® Lispro U200

$7BPrandial insulin market (2015)1

1 Source: Adocia estimates based on major companies annual reports, 2015

Faster BC Lispro improves glycemic control

March 2017 16

BC LISPRO

Liquid meal+ Insulin s.c.

AUC0-2h:

Trial in 38 subjects with type 1 diabetes (NCT#02213146) ; *CI-95% for LSM ratioThese 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).

-61%*

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

Post-meal glycaemia in T1D

For more detailed results, cf. Appendix

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 ; NCT02528396, 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; NCT02562326, 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; NCT02562313, 44

patients) Acceleration demonstrated in 2 pumps & insulin syringe compared to Humalog

injected at mealtime Pilot bioequivalence (BE) study U200/U100 (December 11, 2015; NCT02529293, 26

volunteers) Predefined criteria for BE were met

Study in healthy Japanese subjects (May 31, 2016; NCT02660502, 15 patients) Confirmed BC Lispro PK/PD profile, allowing Japanese patients inclusion in Phase 3

March 2017 17

BC LISPRO

A true combination of two gold standard insulins - glargine as basal and lispro as prandial

March 2017 18

BC COMBO

Insulin lisproHumalog®

Insulin glargineLantus®

BioChaperone® COMBO

6 10 14

18

22 2 6

6 10 14

18

22 2 6

6 10 14

18

22 2 6

6 10 14

18

22 2 6

Once-a-day

Twice-a-day

6 10 14

18

22 2 6

vs. Premix insulin

Twice-a-day

+ =

Schematic PK representations

Adocia is developing a simple 2-in-1 option for tight basal and prandial control

March 2017 19

BC COMBO

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

Potential benefits*

BioChaperone® Gla Lispro(BC Combo)

*As demonstrated clinically by the only comparable approved product, Ryzodeg (Novo Nordisk)

$5BPremix insulin market (2015)1

1 Source: Adocia estimates based on major companies annual reports, 2015

BC Combo has shown superior prandial and basal control compared to premix insulin in people with T1D

March 2017 20

BC COMBO 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

BGmin +30%2

Less hypo

Individualized doses

∆AUC0-2h -24%1

Less hyper

Trial in 28 people with T1D (NCT#02514954); 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).

Post-meal glycemia in T1D

Liquid meal+ Insulin s.c.

For more detailed results, cf. Appendix

BC Combo 75/25 confirmed its promising profile compared to premix insulin in people with T2D

March 2017 21

BC COMBO T2DM

Trial in 24 people with T2D (NCT#02514850).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).

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 T1DExpected to start Q2 17

Planned Outpatient study in T2DExpected to start Q4 17

Fast 24hr +

Sharp transition

For more detailed results, cf. Appendix

Adocia intends to deliver affordable prandial insulin to price-sensitive populations

March 2017 22

HINSBET

Affordable prandial insulin

Dosing closer to mealtime

Potential benefitsHinsBet® U100

HinsBet® U500

$1BHuman prandial insulin market (2015)1

1 Source: Adocia estimates based on major companies annual reports, 2015

HinsBet displays similar early action to fast-acting insulin analog in T1D patients

March 2017 23

HINSBET

Early Glucose Infusion Rate (U100)

PK/PD clinical trial in 36 subjects with type 1 diabetes (NCT#02213146).

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

markets1Meal-test study in 36 subjects with type 1 diabetes (NCT#02739906). 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.

NEW PROGRAMS

March 2017 24

How to potentialize insulin action?

March 2017 25

MULTI-HORMONA

L

Insulin

Glucagon

GLP-1 Amylin

In combination

BC Glargine GLP-1BC Lispro PramlintideBC Lispro Exenatide

In a dual-chamber pump

BC Glucagon + Insulin

Efficacy

Safety

Among a multitude of metabolic hormones, 4 classes have been approved for the treatment of diabetes

March 2017 26

DIABETES

Pancreas Produces insulin, amylin & glucagon

IntestinesProduce GLP-1

Multiple targets of action of: insulin amylin (pramlintide) GLP1 (GLP1-RA) glucagon

In healthy people, a time-sensitive hormonal pattern maintains normoglycemia

March 2017 27

DIABETES

0 1 2 3 4 5 6

Insulin

Amylin

Glucagon

GLP-1

Meal

0 1 2 3 4 5 6

Meal

InsulinAmylin

Glucagon

GLP-1

Healthy With Type 1 diabetes (T1D)

Time

Leve

l of s

ecre

tion

(rel

ative

scal

e)

In T1D, hormonal pattern is severely disrupted

Insulin, Amylin and GLP-1 are secreted

X Glucagon is suppressed

Schematic representation of hormonal pattern1

1 Source: Adocia, adapted from Toff-Neilsen et al, J. Clin Endocrinol Metab 2001;86:3717-3723; Cummings DE et al, Diabetes 2001;50:1714-1719; Aronoff SL et al , Diabetes Spectrum 2004; 17(3): 183-190

People with T1D need multi-hormonal treatment to improve long-term outcomes

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

March 2017 28

BC PRANDIAL COMBOS

Complications1

heart disease, retinopathy, nephropathy,

blindness, amputations…

36%3 of children with

T1D are overweight or obese

65%2 of US adults 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):398-404. BMI>25, Data for 2004-2007 period. 3Du Bose et al, J Ped 2015, data for Germany & the USA, WHO BMI categories.

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

March 2017 29

BC GLUCAGON

Bloo

d gl

ucos

e co

ncen

tratio

n

INSULIN

GLUCAGON

Adocia aims to greatly enhance insulin pump therapy with stable and soluble human glucagon

March 2017 30

BC GLUCAGON

* For illustration purposes only

Relieve patient from risk of hypoglycemia, especially at night

More time-in-range (less hypoglycemia & less hyperglycemia)

More freedom to live “normal” everyday life

Potential benefits

BioChaperone® Human Glucagon

DHAP : Dual-hormone artificial pancreas Automated administration of insulin and glucagon

under continuous glucose monitoring (CGM)

CGMInsulin

Glucagon

*

*

DHAP is a promising system to achieve truly automated closed-loop glycemic control

March 2017 31

BC GLUCAGON

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.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):233-243

39 individual CGM traces (T1D)

Adocia develops an aqueous human glucagon for use in a DHAP system

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

March 2017 32

BC GLUCAGON

N=7 pigs. Cross-over design BC Glucagon (1 mg/mL) vs. GlucaGen® (Novo Nordisk, 1 mg/mL, reconstituted ex-temporane.)

60

80

100

120

140

160

180

0 20 40 60 80 100 120 140 160 180

G001

G014, W37-16

Mean blood glucose (pigs)

0

20

40

60

80

100

120

140

160

180

0 20 40 60 80 100 120 140 160 180

Glucagen 1 µg/kgBC Glucagon 1 mg/mL 1µg/kg

0

20

40

60

80

100

120

140

160

180

0 20 40 60 80 100 120 140 160 180

Glucagen 1 µg/kgBC Glucagon 1 mg/mL 1µg/kg

0

20

40

60

80

100

120

140

160

180

0 20 40 60 80 100 120 140 160 180

Glucagen 1 µg/kgBC Glucagon 1 mg/mL 1µg/kg

Adocia is developing efficient and affordable intensification options over basal insulin for T2D

March 2017 33

BC GLAR GLP-

1

Better control than basal alone

Fewer side effects than each product separately

Weight neutral

Only 1 daily injection

Potential benefits*BioChaperone® Glargine Dulaglutide

BioChaperone® Glargine Liraglutide*As demonstrated clinically by approved products Xultophy® (IDegLira) & Soliqua® (IGlarLixi)

$7BForecasted Basal-GLP1

market (2019-2020)1

1 Source: Leerink forecasts, October 6, 2016

Two injectable combos for better and/or more affordable intensification options in T2D

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 2017, based on positive CMC & preclinical results

March 2017 34

50%1Patients on

basal insulin are not

adequately controlled1

« All-in-1 »

1 product 1 injection 1 co-pay

Xultophy® (IDegLira, NVO)

& Suliqua®/Soliqua® (IGlarLixi, SAN) approved in EU & US (2016)

1 Sanofi, JP Morgan Healthcare Conference Presentation , San Francisco, January 12, 2015.

BC GLAR GLP-

1

Enabling new prandial insulin combinations with already proven medical benefits

March 2017 35

BC LISPRO COMBOS

Better control than prandial insulin alone

Weight loss or weight neutrality

Fewer side effects than each product separately

No increase in injection burden

Potential benefits*BioChaperone® Lispro Pramlintide

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

-25-20-15-10

-50

Change in prandial insulin dose after 6

months (%)

Pramlintide (TID) clinically proven synergistic benefits with mealtime insulin in people with T1D

March 2017

PRAMLINTIDE

36

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), 203-212. and in T2D only: Karl D, et al. Diabetes Technol Ther 2007; 9(2):191-199 .

-3.5-3

-2.5-2

-1.5-1

-0.50

Change in weight after 6 months (kg)

-22%*

-0.2%*

-3 kg*

Blood glucose control (T1D)

Adocia intends to develop easy-to-use combinations of insulin/pramlintide for people with T1D

Prandial suppression of glucagon

Slowed gastric emptying

Appetite reduction-0.2%*

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

Delta glucose in blood after a mixed meal150

100

50

0

-50

-1000 100 200 300

Delta

glu

cose

(mg/

dL)

insulininsulin + exenatide 1.25µginsulin + exenatide 2.5µg

Time (min)

Exenatide clinically proven synergistic benefits with mealtime insulin in people with T1D

March 2017

EXENATIDE

37

Adapted from Raman VS, et al. Diabetes Care 2010 Jun; 33(6): 1294-1296.

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.

Adocia to develop easy-to-use combinations of insulin/GLP-1 for people with T1D

Unlocking the potential of prandial insulin combinations

March 2017 38

BC LISPRO COMBOS

Prandial Insulin (Lispro)

Pramlintideor

Exenatide

3 injections/day

2 or 3 injections/day

Increases glucose disposal

Modulate glucose appearance

+ BioChaperone

unmixable

BioChaperone Lispro Combos

3 injections/day or CSI

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 populationMarch 2017 39

BC LISPRO COMBOS

Insulin lispro + PramlintideInsulin lispro + Exenatide

Key financial elements

March 2017 40

ADOCIA

Shareholders’ equity (November 30, 2016)

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

Analysts

Leerink (Seamus Fernandez)Jefferies (Peter Welford)Kepler Market (Arsène Guekam)Invest Securities (Martial Descoutures)Oddo (Sébatien Malafosse – Pierre Corby)Louis Capital Partners (Pierre Vaurice)

Financial summary

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%

(*) including US investors from March, 2015 private placement of 10% of the capital (KKR, Alken, BVF and others)

Expected upcoming catalysts

March 2017 41

ADOCIA

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

Clinical programs Preclinical programs

APPENDIX

March 2017 42

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 43

ADOCIA

Results summary compared to Humalog U100 in T1DM subjects

March 2017 44

BC LISPRO

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 ExposureGreater Earlier Exposure: Faster In

Lower Late Exposure: Faster Out Better Post Prandial Glucose Control

GeoLSMBC

Lispro

GeoLSMHumalog

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]

GeoLSMBC

Lispro

GeoLSMHumalog

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]

GeoLSMBC

Lispro

GeoLSMHumalog

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 42BG2h (mg/dL) 126 153 27

294-OR in Novel Therapeutics in T1D, June 13, 2016, 76th ADA Scientific Sessions

Results summary compared to Conventional Lispro Mix 75/25 in T1DM subjects

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BC COMBO

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 PopulationParameter Mean ± SD Parameter Mean ± SD

SexFemale: 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) 0

Height (cm) 177 ± 8 HbA1c (%) 7.33 ± 0.80

Weight (kg) 76 ± 10 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)

Parameter BC Combo

Lispro Mix

P-value

Subjects with at least one

hypoglycaemic event7 / 27 15 / 28 0.03641

Number of hypoglycaemic

events12 29 0.00791

Number of hypoglycaemic

event per subject02 12 0.01513

Hypoglycaemic events

1 Chi-Square test

2 Median 3 Wilcoxon Signed Rank test

295-OR in Novel Therapeutics in T1D, June 13, 2016, 76th ADA Scientific Sessions

Results summary compared to Humalog 75/25 in T2DM subjects

March 2017 46

BC COMBO

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 (ADA2016 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, 0.8 U/kg HumalogMix 75/25

and Separate Injections of 0.2 U/kg Lispro + 0.6 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 0.2 U/kg

Lispro + 0.6 U/kg Glargine

PD Parameters Based on Glucose Infusion RateBC Combo Humalog Mix 75/25 P-value vs. BC

ComboLispro _ glargine P-value vs. BC

ComboPramdial Phase (0.6h)AUCGIR 0-1h [mg/kg] 88 (74) 29 (34) <0.0001 58 (48) 0.0087AUCGIR 0-2h [mg/kg] 294 (227) 174 (126) 0.0001 277 (184) 0.5227AUCGIR 0-6h [mg/kg] 860 (536) 1011 (535) 0.0335 1121 (556) 0.0003TGIRmax [h] 1.3 [1.2;5.1] 3.8 [1.8;6.0] <0.0001 2.9 [1.4;4.9] 0.0057Prandial – Basal Transition (6-12h)AUCGIR 6-12h [mg/kg] 589 (275) 870 (501) 0.0002 630 (211) 0.3420AUCGIR 6-24h [mg/kg] 1075 (615) 1481 (911) 0.0001 1156 (551) 0.4522Basal Phase (12-30h)AUCGIR 12-18h [mg/kg] 342 (225) 473 (354) 0.0063 382 (221) 0.2156AUCGIR 24-30h [mg/kg] 186 (133) 99 (102) 0.0105 174 (139) 0.6747OverallAUCGIR 0-30h [mg/kg] 2122 (1184) 2590 (1368) 0.0103 2451 (1071) 0.0124Table shows arithmetic means (SD) except median [min;max] for TGIRmaxP-value from Hodges and Lehmann Estimates or (for AUCGIR 0-6h and AUCGIR 0-

30h) from LS Means

942-P in 12-B Clinical Therapeutics/ New Technology-Insulins, June 11, 2016, 76th ADA Scientific Sessions

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