Corporate Presentation - January 2022 - Adocia
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Corporate Presentation January 2022
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
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Corporate Presentation 2
Highly experienced management team
Gérard Soula Olivier Soula Valérie
PhD, MBA PhD, MBA Danaguézian
Deputy General Manager,
President & CEO Director of R&D Chief Financial Officer
Co-founder Co-founder
Jérémy Benattar Michael
PharmD, Eng Nguyen
Director of Marketing & Head of BD,US
Strategy
• Co-founded by Gérard, Olivier and Rémi Soula in 2005
• IPO on Euronext-Paris in 2012
• 115 staff, incl. 42 PhDs/MDs located in Lyon, France
Corporate Presentation 3
Executive Summary
Our mission: to develop innovative formulations of approved
1 hormones for the treatment of diabetes and obesity
2 Our business model: product licensing after proof-of-concept
Our pipeline is based on our 3 patented technology platforms:
3 • 1 product approved to enter in Phase 3 in China NEW
• 5 products with clinical proof-of-concept
• 6 preclinical stage projects
4 €19.6m1 cash on-hand
1. As of 10/31/2021 Corporate Presentation 4
Adocia’s vision: addressing metabolic diseases from hormonal
to cell therapies
Improving islets of Langerhans transplant with hydrogel matrix for diabetes
Oral Formulations of hormones for diabetes and obesity
Hormones combinations for diabetes and obesity
Improving insulin-therapy
Adocia is taking on high challenges, that requires innovative mindset and expertise
Corporate Presentation 5
Diabetes and Obesity: worldwide chronic pandemics
463 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 treatment
1.9 billion are overweight or obese2
1 in 4 AMYLIN
Diabetes GLP-1 Obesity
GLUCAGON
Adocia’s goal is to deliver innovative hormonal formulations to patients affected by
diabetes and obesity
1. IDF Atlas, 9th Edition, 2019
2. WHO
3. Conway et al, Diabetes Med 2010 April; 27(4):398-404. BMI>25, Data for 2004-2007 period
Corporate Presentation 6
4. Epidemiology of Obesity and Diabetes and Their Cardiovascular Complications
A well-advanced and diversified pipeline with products ready to partner
Preclinic Phase 1 Phase 2 Phase 3 Upcoming milestones
BC Lispro Phase 3 in China expected in 2022
Ultra-Rapid Insulin
U100 / U200 Phase 3 in USA and Europe expected in 2022*
Insulins Combination
BC Combo U200 Phase 1 expected in 2022
Long acting + Rapid acting
Hypoglycemia treatment BC Glucagon Development on hold until a partnership is secured
Diabetes M1Pram Q1 2022: Phase 2 T1D – MDI results
BC LisPram
Multi-Hormonal Therapy Q2 2022: Phase 1 T1D - pump study results
BC AsPram
BC GlaLira Development on hold until a partnership is secured
Patent application filed
Cell Therapy for diabetes
2022: First in Human
PramExe 2022: First in Human
Multi-Hormonal
Obesity BC GluExe 2022: First in Human
Therapy
BC PramGluExe Patent application filed
Patent application filed
Oral Delivery of peptides
2022: First in Human
BC: BioChaperone®; Lispro: insulin lispro; BC Combo: BC insulin glargine insulin lispro; MDI: Multiple Daily Injection
M1: A21G human insulin; Pram: pramlintide; Glu: Glucagon; Gla: insulin glargine; Exe: exenatide, *: upon partnership signature 7
BioChaperone® platform (BC) potentializes performance of insulins
and other hormones
BioChaperone® Proteins and peptides
(insulin, amylin, GLP-1 RA, glucagon…)
• Pharmaceutical excipient
• 50 patents filed
[BioChaperone® Protein]
Complex
Improved solubility Accelerated absorption
Improved stability Protection against enzymatic degradation
Efficacy improvement of insulin alone or in combination with other hormones
5 proprietary products based on BioChaperone® technology in clinical development
Corporate Presentation 8
Diabetes
Corporate Presentation 9
BioChaperone® Lispro
The next best-in-class Rapid Acting
Insulin for a tighter glycemic control
Corporate Presentation 10BC 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
• Good tolerance for optimized daily use AUC0-2h:
-61%*
• Range of strengths (U100 & U200), adapted
to pump miniaturization and patients’
requirements
Liquid Meal
+ Insulin s.c.
The combination of a good local tolerance, a U200 formulation and a faster release of insulin
will put BC Lispro in a strong position to compete with the other Ultra Rapid Insulins
Trial in 38 subjects with type 1 diabetes (NCT#02213146) ; *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). 11BC Lispro, a competitor in the Ultra-Rapid Insulins class
Only 3 ultra-rapid insulins will compete in the $9bn1 prandial insulin market,
addressing the needs of 34 millions mealtime insulins users (T1D + T2D):
BC Lispro
• Licensed to Tonghua Dongbao (THDB) for development & commercialization for
Chinese market2:
• $10m upfront
• $35m upcoming development milestones 78%
• Double-digit royalties of revenue
from
$3,3bn
• Global supply agreement for GMP lispro for the development and insulin3
Market Cap4
commercialization of BC Lispro outside licensed territories
NEW
Chinese regulatory authorities’ approval granted to start phase 3 in China
Finding partners for BC Lispro for US, Europe and Japan remains Adocia’s priority
1. Adocia estimates based on major companies’ 2019 annual reports
2. China and other territories (excluding US, EU, Japan)
3. Data THDB
4. August 2021 Corporate Presentation 12BC Combo: basal-bolus
insulin combination
Insulins glargine & lispro
Corporate Presentation 13BC 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
Improved glycemic control
Trial in 28 people with T1D (NCT#02514954); * p=3.10-3;**p=8.10-3
BC Combo offers better performance than Humalog Mix, current
standard of care on the premix market
1. Adocia estimates, based on market leaders annual reports and IQVIA MIDAS data 2019
Corporate Presentation 14BC 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 ~65% • Double-digit royalties on sales
patients Market share in
India and China
(volume)1
Clinical trial preparation is ongoing to qualify Tonghua Dongbao’s insulins
1. Adocia estimate based on major companies' annual reports 2019
2. China and other territories (excluding US, EU, Japan) Corporate Presentation 15
3. Data THDBMulti-hormonal combinations
Insulin in combination with other
hormones
Corporate Presentation 16Adocia has in hand the next generation of insulin-based treatment
Multi-hormonal
combinations
Medical M1Pram, BC LisPram/
benefits BC AsPram
Ultra-Rapid Insulins
BC Lispro,
Fiasp®, Lyumjev®
Rapid Acting Insulins
Humalog®, Novolog®
& biosimilars
Human Insulins
Animal Insulins Humulin®, Novolin®
Hypurin® Bovine
or Porcine
Treatment
1st generation 2nd generation 3rd generation 4th generation 5th generation generations
Potential Potential
Best-In-Class First-In-Class
With flagship products M1Pram, BC LisPram, BC AsPram, Adocia has the
potential to deliver First-In-Class products
Corporate Presentation 17M1Pram
BC LisPram / BC AsPram
Insulin-Amylin 2-in-1 products:
a therapeutic breakthrough
Corporate Presentation 18Glycemic control requires the synchronized action of insulin and amylin
Meal Without diabetes
Pancreas Insulin
Level of secretion
(relative scale)
Amylin
Insulin Glucagon
Produced 0 1 2 3 4 5 6
Produced Glucagon by α-cells Time (hours)
by β-cells Meal With diabetes
Level of secretion
Glucagon is dysregulated in
(relative scale)
Amylin Glucagon the absence of amylin
Insulin
0 1 2 3 4 5 6
Amylin
Time (hours)
T1D: β-cells are destroyed by the immune system
T2D: β-cells mass progressively decreases
Corporate Presentation 19Symlin® (pramlintide, an amylin analog) was approved by FDA in
2005 as an adjunct to insulin treatment for T1D and T2D
The amylin effects in physiology The evidences demonstrated by pramlintide
Activates amylin receptors in
different brain areas
Satiety
Improvement of HbA1c
Protects cognitive functions Better glycemic control with an increase of the
Well-being Time-In-Range
Inhibits glucagon secretion by
pancreatic alpha cells
Significant weight loss
Better glycemic control
Lower Post Prandial
Glucose rise
Diminution of prandial insulin consumption
Slows gastric emptying time towards normal
Synchronize the blood glucose rise and the
arrival of insulin
Two hurdles have impeded the use of Symlin®:
• A compliance issue with 3 injections per day over and above 4 insulin injections
• The high price of the drug ($2,000 USD/month)
1. Average Wholesaler Price, Diabetes Care 2021;44(Suppl. 1):S11-S124 Corporate Presentation 20Adocia is developing insulin-amylin combinations for pen
and pump
Optimal product profile for MDI in pen Optimal product profile for pump
Regular insulin analog + Pram Rapid insulin analog + Pram
M1Pram BC LisPram
BC AsPram
Q1 2022: Phase 2 T1D results Q2 2022: Phase 1 T1D results
MDI: Multiple Daily Injection M1: A21G human insulin;
Pram: Pramlintide
BC: BioChaperone
Lis: Insulin lispro; As: Insulin aspart Corporate Presentation 21Promising Phase 1b results of M1Pram in pen vs Novolog
Phase 1b – CT038: n=40 T1D
3-week outpatient trial - M1Pram vs. Novolog (Part B n=16; High dose of insulin)
Average glycemia Weight Time In Range
164 0,5 16,2
162 0,4 16
0 15,8
160
-7 mg/dL -2 kg 15,6
+58 min
-0,5
Hours
158
mg/dL
p=0,01 p=0,0065 15,4 p=0,04
kg
156 15,2
-1
15
154
-1,5 -1,6 14,8
152 14,6
162 155 14,99 15,95
150 -2 14,4
p=0,0065 p=0,04
p=0,01
Novolog® M1Pram
• Good tolerability
• 75% patients recommended M1Pram
Corporate Presentation 22M1Pram offers better glycemic control and weight loss
M1Pram leverages pramlintide’s clinical benefits
“This combination has the potential to
Targeted phase 2 results: finally deliver on the promise of pramlintide
for a large number of patients.”
HbA1c decrease: [-0,3% ; -0,5%]
Prof. Robert Ratner,
Significant weight loss: [-4kg ; -7kg] Georgetown University
Washington DC
Flatter Post Prandial Glycemia
“The glycemic results with M1Pram to date are quite “Remarkably, after only 3 weeks of treatment
promising as is the observed weight loss, which is with M1Pram, all known pharmacological
important given the characteristics of the population effects of pramlintide were observed.”
taking prandial insulin. I look forward to the next series
of clinical trials.” Prof. Thomas Pieber,
Jay S. Skyler, Medical University of Graz,
University of Miami Austria
Leonard M. Miller School of Medicine
Phase 2 T1D ongoing – First results Q1 2022
1. Guthrie R et al Diabetes 2005, 54(Suppl 1):A118 T1D, pramlintide +insulin vs insulin alone, after 6 months -0.3% A1c, -3kg. See also
Pullman J et al Vasc Health Risk Manag. 2006, 2 (3), 203-212 and in T2D : Karl D, et al. Diabetes Technol Ther 2007; 9(2):191-199.
Corporate Presentation 23
2. NCT03981627BC LisPram: the optimal combination for pumps
Clinical Proof-of-Concept established at Mc Gill University, Canada, by Dr. Ahmad Haidar, comparing Lispro in
one pump vs. Lispro and Pramlintide administered simultaneously in two separate pumps, over one month1
n=29 T1D
Results
• 10% improvement of
Time in Range
RANGE
• 93% patient satisfaction
BC LisPram is currently tested in clinic with Dr. Ahmad Haidar with one single
product/pump system and results are expected end of Q2 2022
Corporate Presentation 24
1. A. Haidar et al at McGill University Diabetes care Jan 2020Cell Therapy
Innovative Scaffold for
Pancreatic Cell Therapy
Corporate Presentation 25Adocia developed an innovative hydrogel scaffold to
protect and host islets of Langerhans transplants
Hydrogel scaffold
Transplant Organoid
Islets sourcing
(Allogenic/stem-cell)
External source
Adocia’s goal is to propose a life saving therapy to insulino-resistant patients
Corporate Presentation 26Development achievements
Innovative Hydrogel
Well tolerated Insulin secretion Encapsulated Islets
in response to glucose Naked Islets
Long term stability and fully retrievable
Patents application filed 3G 15G 3G
6
Islets encapsulation
Normalized insulin secretion
5
Simple and cell-friendly process 4
Human islets viable and functional
3
Fast insulin delivery to glucose stimuli
2
In vivo grafting results 1
Minimally invasive surgical procedure 0
Well tolerated in rabbit 0 20 40 60
time (min)
POC of Immunoisolation in mice
Adocia aims to obtain human proof-of-concept in 2022
Corporate Presentation 28Obesity
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”
Corporate Presentation 29Combinations of “diabetes” hormones appears to be a revolutionary
way to treat obesity
Product Class Mean Mean
Weight Loss Weight Loss
expected Targeted
(standalone) (combo)
AMYLIN
PramExe Amylin analog -7,9%1
-15%
Pramlintide Exenatide GLP1-RA - 8%2
Diabetes GLP-1 Obesity
BC GluExe Glucagon -7 to -9%
-15%
GLUCAGON BioChaperone® Glucagon Exenatide GLP1-RA - 8%
BC PramGluExe Amylin analog -7,9%
BioChaperone® Pramlintide Glucagon Glucagon -7 to -9% -20%
Exenatide GLP-1 RA - 8%
Adocia has selected hormones with potential synergistic effects, to offer
patients powerful treatment options
1. Smith et al. Diabetes Care. 2008 Sep; 31(9): 1816–1823. doi: 10.2337/dc08-0029 – 360µg TID over 12 months – obese population
2. Exenatide not tested on obese population – results expected to be comparable to Liraglutide 3,0mg on SCALE Obesity and Prediabetes phase 3 study: N Engl J Med. Corporate Presentation 30
2015 Jul 2;373(1):11-22. doi: 10.1056/NEJMoa1411892.A first Proof-of-Concept has been established in obese mice with
Biochaperone® Glucagon Exenatide (BC GluExe)
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%
weight loss compared to
60 Values expressed as mean of n = 6-12 + SEM vehicle
Dunnett’s test one-factor linear model
***: P < 0.001 compared to Saline
50
-5 -4 -2 0 2 4 6 8 10 12 14
Study day
A first combination should enter in Proof-of-Concept in Human study in 2022
Corporate Presentation 31Adocia is developing patient-centric treatments
CURRENT PARADIGM ADOCIA’S PARADIGM
Long acting GLP-1 RA are being developed to limit the The patient wears a patch-pump
number of injections to deliver combinations of short
acting hormones
However, despite demonstrated efficacy, GLP-1 RA class
goes along with side effects: It provides a convenient, easy to
• Nausea, vomiting, diarrhea, pain… use and affordable way to adjust
their treatment dose, for
Patients using long-acting forms cannot interrupt side maximum efficacy and
effects, representing a significant burden minimum inconvenience
Short stay-time Prolonged stay-time
Discontinuation leads to weight regain Maintained weight loss
Real-World Adherence and Discontinuation of Glucagon-Like Peptide-1 Receptor Agonists Therapy in Type 2 Diabetes Mellitus Patients in the United
States, T. Weiss, 2020 Nov 27;14:2337-2345. doi: 10.2147/PPA.S277676. eCollection 2020.
Corporate Presentation 32Patient’s reasons to adopt short-acting hormones in pump
n days infusion n days infusion
1 day off
Concentration 4x
Patient can:
• Intensify the treatment by increasing
Concentration 2x the dosage to obtain maximum results
Concentration 1x
• Stop temporarily by switching it off, to
suspend immediately unwanted effects
Time (h)
*
Go Stop Go
With Adocia’s solution, patients can personnalize their treatment to
obtain desired weight loss, without compromizing their quality of life
*For illustration purposes only
Corporate Presentation 33Oral delivery
Corporate Presentation 34Adocia’s oral delivery technology of hormones for diabetes and
obesity
The context Adocias’ proposal
• Peptides and proteins widely used as drugs but only • Adocia has developed a formulation enhancing the
available in injectable forms efficiency of peptides absorption by the
Burden for patients gastrointestinal tract
Limited adoption Switch from injectable to oral forms
• Challenge: peptides are not absorbed in the digestive
tract and are degraded before reaching the • Promising results in large animals with the oral
bloodstream administration of a GLP-1 RA for diabetes treatment
• First-in-Human study: planned for 2022
Adocia’s technology is currently presented to biopharma companies
Corporate Presentation 35Financial & news flow
Corporate Presentation 36News flow
BC Lispro M1Pram PramExe – BC GluExe
• In China: Phase 3 start • Phase 2 study in T1D in MDI • In-Human Proof-of-concept
expected in 2022 (Multiple Daily Injection) in 2022
ongoing
• In USA/EU: Phase 3 launch
scheduled in 2022 • Results expected Q1 2022
Cell Therapy
• FIH study 2022
BC Combo BC LisPram
• Tonghua Dongbao insulins • Phase 1 study in TD1 pump:
qualification studies ongoing Oral delivery
preparation ongoing
• Results expected end of • FIH study 2022
Q2 2022
Corporate Presentation Corporate PresentationKey financials & shareholder information
Key financials features1 Shareholder ownership Market information
Already received • Listed on Euronext Paris (ADOC)
• €85m raised since inception Soula Family
• 7.2m shares outstanding
• $120m received from partnership 22,5% • ADR program in the US (ADOCY)
Expected milestones payment Free float
• $85m as per contract with THDB + 59,5%
royalties
BPI 10,9%
Cash position: €19.6m Sham 4,4% Analyst coverage
Oreo Finance 0,6%
• Kepler Chevreux - Arsène Guekam
Debt: €33m Viveris 0,1%
• Oddo - Oussema Denguir
• Financial debt for building acquisition & Key managers 2,0%
• HC Wainwright – Douglas Tsao
renovation: €5m (2006)
• IPF Debt: €15m (2019)
• State-guaranteed loan (PGE): €7m (mid-2020)
• Convertible bonds: €6m (Oct 2021)
Corporate Presentation 38
1. As of 10/31/2021Summary
• A well-advanced and diversified pipeline with products ready-to-license:
• 5 products with clinical proof-of-concept based on its proprietary BioChaperone® platform
o BC Lispro is planned to enter in Phase 3 in China in 2022 and Adocia is seeking partners for Europe, US, Japan
o BC Combo clinical trial preparation is ongoing to qualify Tonghua Dongbao’s insulins
o M1Pram and BC LisPram clinical results in Type 1 Diabetes are expected in 2022
• First hormonal combinations for obesity treatment to be tested in human in 2022
• Cell Therapy scaffold is expected to be tested in human in 2022
• Oral Delivery technology is expected to be tested in human in 2022
• $85m in development milestones to come from Tonghua Dongbao partnership
• Cash position: €19.6m1
1. As of 10/31/2021 Corporate Presentation 39Thank you for your kind interest 115 avenue Lacassagne 69003 Lyon – FRANCE Ph.:+33 4 72 610 610 contact@adocia.com
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