Adocia Corporate Presentation (English)
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Adocia Corporate Presentation (English) Adocia Corporate Presentation (English) Presentation Transcript

  • ADOCIA - CORPORATE PRESENTATION Corporate Presentation April 2014
  • April 2014 2 Receipt of this presentation implies your agreement with the restrictions outlined below. This presentation does not constitute or form part of, and should not be construed as, an offer of securities for sale or an invitation or inducement to invest in securities in France, the United States or any other jurisdiction. Securities may not be offered or sold in the United States absent registration or an exemption from registration. No public offering of securities will be conducted in France or abroad prior to the delivery by the French Autorité des Marchés Financiers (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 this presentation may be restricted by law and persons into whose possession this presentation comes should inform themselves about, and observe, any such restrictions. This presentation includes only summary information and does not purport to be comprehensive. Certain information included in this presentation are not historical facts but are forward-looking statements. The forward-looking statements are based on current beliefs, expectations and assumptions, including, without limitation, assumptions regarding present and future business strategies and the distribution environment in which Adocia operates, and involve known and unknown risk, uncertainties and other factors, which may cause actual results, performance or achievements, or industry results or other events, to be materially different from those expressed or implied by these forward-looking statements. Forward-looking statements speak only as of the date of this presentation and are for illustrative purposes only. Forward-looking information and statements are not guarantees of future performances and are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Adocia, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Disclaimer Property of Adocia
  • • Founded in 2005 by Gérard, Olivier and Rémi Soula  Listed on Euronext Paris: ADOC.PA since February 2012  Implementation of an ADR program in the US (ADOCY) ongoing  Cash position of €16 M at the end of 1Q2014, burn rate of €11 M in 2013 and €73 M stock market valuation (April 28, 2014).  Experienced management and 74 staff, including 24 Ph.D. • Platform technologies:  BioChaperone® platform: a major leap to improve protein performance for insulin, growth factors, mAbs…  DriveIn® nanotechnology for targeted drug delivery in oncology  New technologies for mAb formulation • A mature portfolio of 3 insulin products with BioChaperone in phase 2 • A product for chronic wound healing ready to enter phase 3 Adocia in brief April 2014 3Property of Adocia
  • April 2014 Adocia: a solid and diversified pipeline Property of Adocia 4
  • April 2014 Property of Adocia 5 • Development of innovative products based on already approved therapeutic agents up to the “Proof of Concept” established in clinical trials. • Licensing of Adocia’s innovative products to commercial partners:  Receive upfront and milestone payments  Royalties on partner’s sales  Transfer the full clinical development to the partner  Assist the partner for a complete development of the product. Adocia’s strategy : to be a worldwide leader in innovative formulation of therapeutic agents Low capital intensive model with a fast ROI
  • BioChaperone, a polysaccharide derivative, mimics some properties of heparin:  Ability to form molecular complexes with therapeutic proteins  Improvement of these therapeutic proteins: − Increased solubility − Protection against enzymatic degradation − Extended duration of action BioChaperone is a versatile technological platform for the formulation of hormones, growth factors and monoclonal antibodies BioChaperone BioChaperone-Protein Complex Protein BioChaperone®: a major leap towards improving protein performance April 2014 6Property of Adocia
  • April 2014 1. Insulin therapy 2. Wound healing 3. DriveIn: nanotechnology for targeted delivery 4. Formulation of monoclonal antibodies Product Breakthroughs Property of Adocia 7
  •  Human insulin market: $3.5 billion  Insulin analog market: $19.4 billion Insulin products: $22.9 billion(1), CAGR 15.7% (2008-2013)(1) Our challenge: bring innovation to existing products which will soon be off-patent April 2014 8 Human Insulin Fast acting Analog Long acting Insulins Premix Insulins Insulin Combos (long+fast-acting) Novo Nordisk Novolin N & R ($2.0B) NovoLog® ($3,1B) 2014* Levemir® ($2,1B) 2018* Tresiba® (Eur/Jap) 2024* Novomix® ($1.8B) Ryzodeg® (Eur/Jap) Eli Lilly Humulin family ($1.3B) Humalog® ($1,95B) 2013* / Humalogmix® ($0,65B) / Sanofi Insuman® ($0.2B) Apidra® ($0.4B) 2017* Lantus® ($7.8B) 2015* / / * Year product is off-patent Property of Adocia Sources: (1) Novo Nordisk, Full year 2013 presentation Feb 2014; All other figures: Companies Financial reports 4Q13, except Apidra and Insuman: Sanofi’s Annual Report 2013.Humalog/HumalogMix split by Adocia’s estimate
  • April 2014 Property of Adocia 9 Fast Acting insulin Ultra-fast acting analog insulin Long acting analog insulins Premix insulins Insulin Combos (long+fast-acting) Novo Nordisk / FIAsp (FA Aspart, Phase III) Once-a-week (phase I) / / Eli Lilly / / PEG-Lispro* (Phase III) / / Sanofi / / Glargine 300 UI/ml (Phase III) / / Adocia HinsBet® (New Phase IIa 4Q14) Ultra-fast Lispro (New phase IIa 2Q14) / / Combo Glargine/Fast acting analog (New phase IIa 3Q14) Biodel BIOD-123 (FA RHI,Phase II) BIOD-XXX (FA-Lispro, Prototype formulations)1 / BIOD-531 (U400 RHI, Phase I) / Halozyme - FA Humalog (Phase II) / / / Innovation through formulation is the next step for the insulin market *PEG-Lispro, only modified insulin analog; FA= Fast-acting ; RHI: Recombinant Human insulin; Insulin Glargine=Lantus® 1 After completing a successful Phase 1 clinical trial with BIOD-250, Biodel went back to prototype formulations to improve product stability of ultra-fast formulations
  • April 2014 Property of Adocia 10 • 4 global players:  Eli Lilly with a biosimilar of insulin Glargine (filed with EMA and FDA)  Sanofi with biosimilars of 2 insulins, most probably Lispro and Aspart  Mylan with Biocon which commercializes all the insulin analogs for the Indian market  Merck with Samsung Bioepis to develop insulin Glargine (phase 3) • Regional players are also proposing insulin analogs:  Wockhardt in India  Gan&Lee, United Lab, DongBao in China Insulin Biosimilars will enter the market Innovation will be key to differentiate in this competitive market
  • April 2014 Property of Adocia 11 • Adocia’s insulin products combine 4 key advantages: 1. Best-in-class performance based on BioChaperone innovation 2. Low development risk based on long safety and efficacy track-records of insulins glargine and lispro 3. Short time-to-market resulting from favorable regulatory guidelines for re- formulation of existing drugs (cf. Novo’s FIAsp) 4. Low cost of development resulting from maturity of insulins and simple add-on BioChaperone technology Adocia’s formulation strategy for insulins Innovative formulation using BioChaperone produces high-performance, low-risk insulin products that can rapidly move to the market.
  • April 2014 12 • Premix are the 1st treatment in Asia: 65% of Diabetics use Premix products in China/India • Premix insulin analog products already represent a $2.45B market in 2013 • Premix are easy-to-use: reduced number of injections, adapted to ageing populations  However, they are not optimal treatments compared to a double injection • Novo’s Ryzodeg Combo showed improved glycemic control in patients vs. premix.  Ryzodeg: Insulin Degludec + Insulin Aspart, approved in Europe & Japan, but not in the USA • No such combo based on insulin Glargine (Lantus, Sanofi), the gold-standard basal insulin, has been developed so far. BioChaperone enables the development of a unique Combo based on Glargine Insulins Combo: the new generation of efficient and patient-friendly insulin products Property of Adocia 1. Combo 2. UF‐Analog 3. HinsBet 1. Combo 2. UF‐Analog 3. HinsBet Adocia’s objectives: offer an efficient and convenient “2-in-1” product  Outperform existing Premix products on glycemic control  Patient-friendly combination of long and fast-acting insulins Adocia’s objectives: offer an efficient and convenient “2-in-1” product  Outperform existing Premix products on glycemic control  Patient-friendly combination of long and fast-acting insulins
  • April 2014 Property of Adocia 13 • BioChaperone enables the combination of insulin glargine with any prandial insulin analog  Solution at pH 7 for insulin chemical stability  Glargine’s long action and prandial insulin fast action preserved in vivo  Shorter clinical development with approved insulins (505(b)(2) application) • Adocia’s combos offer potential competitive advantages over Novo’s Ryzodeg:  Insulin Glargine track-record (over insulin Degludec)  Lower cost: use of mature insulins produced in large quantities • Estimated market opportunity for BioChaperone Combos: $4,3B  Analog Premix market: $2.4 B  Glargine used in a “Basal+Prandial” treatment: $1.9B (est. as ~25% of Lantus sales) Unique BioChaperone Combo based on Glargine BioChaperone Combo combines efficacy and convenience for patients 1. Combo 2. UF‐Analog 3. HinsBet 1. Combo 2. UF‐Analog 3. HinsBet
  • April 2014 Property of Adocia 14 • Design  20 Type I Diabetic patients  Double-blind 2-way cross-over design  BioChaperone Glargine/Lispro Combo (75/25, 0.8 IU/kg) vs. Humalog Mix 25 (0.8 IU/kg)  PK & PD monitored for 30 hours after drug administration under euglycemic clamp • Main preliminary results:  BioChaperone Combo had a greater than 30% faster onset of action as compared to Humalog Mix.  Almost all patients treated with BioChaperone Combo experienced a minimal duration of action in excess of 30 hours (end of monitoring).  Both formulations of insulins (BioChaperone Combo and Humalog Mix) were well tolerated.  PK parameters are consistent with PD and have been accepted for communication to the 74th scientific sessions of the American Diabetes Association (ADA) to be held in June 2014 Positive results of Phase I/II trial for BioChaperone Combo Phase I/II results support the strong potential of BioChaperone Combo
  • 4/28/2014 Property of Adocia - Confidential 15 BioChaperone® Combo Glucose Infusion Rate BioChaperone® Combo is characterized by a faster onset-of-action and a longer duration-of-action than Humalog® Mix25 (Median profiles)
  • 4/28/2014 Property of Adocia - Confidential 16 BioChaperone® Combo Individual Smoothed Blood Glucose Profiles Blood Glucose control is maintained during at least 30 hours with BioChaperone® Combo
  • 4/28/2014 Property of Adocia - Confidential 17 BioChaperone® Combo Median Blood Glucose Profiles BioChaperone improves both prandial and basal blood glucose control End of action (150 mg/dL) Minimal duration of action (118 mg/dL) Good euglycemic control
  • 4/28/2014 Property of Adocia - Confidential 18 BioChaperone® Combo Pharmacodynamics: Key Parameters All key parameters were significantly improved with BioChaperone® Combo Parameter BioChaperone® Combo25 Humalog Mix25 p‐value* Tonset (min) 25.2 (43) 40.2 (33) 0.002 TGIR‐max (h) 2.8 (27) 3.4 (24) 0.015 AUCGIR 0‐2h (mg/kg) 504 (42) 325 (56) 0.001 AUCGIR 12‐30h (mg/kg) 1 480 (61) 961 (58) 0.025 AUCGIR tot (mg/kg) 4 115 (40) 3 321 (34) 0.052 Duration of action (h) 29.8 (2) 17/19 patients ≥30h 25.5 (17) 6/20 patients ≥30h <0.001 Mean (CV%)
  • 4/28/2014 Property of Adocia - Confidential 19 • The clinical POC is established on diabetic patients • BioChaperone complies with FDA and EMA guidelines • Adocia intends to conduct studies to complete the phase I/II program  PKPD in T1D patients: Dose response (3 doses) vs. Premix (Q3 2014 – Q2 2015) • Adocia intends to validate the clinical development plan with FDA and EMA • Preparation of Phase 3 clinical trial:  Toxicity studies, DART, ADME  cGMP manufacturing development BioChaperone® Combo Clinical Development Adocia targets a rapid and cost effective development of BioChaperone Combo
  • April 2014 Property of Adocia 20 • $5.35B Prandial insulin analogs market (>70% market penetration US/EU).  no new insulin analogs are in development, while biosimilars are on the rise • Ultra-fast insulins are the new generation of insulin treatment  Improved prandial glycemic control, comfort of use and dosage accuracy  Well-adapted to pump use (increasing in both T1D and T2D populations), and necessary for the development of artificial pancreas • Novo develops a new formulation of insulin aspart, FIAsp, with an ultra-fast action:  Aim: Optimize glycemic control compared to NovoLog and enable artificial pancreas  FIAsp entered Phase 3 straight from positive Phase 1 results • BioChaperone can accelerate the action of all 3 marketed prandial insulin analogs. • In July 2013, Adocia reacquired exclusive development rights to ultra-fast acting insulin analogs from Eli Lilly. Ultra-fast insulin analogs aim to improve glycemic control Adocia’s ultra-fast BioChaperone insulin analogs belong to a new generation of prandial insulins 1. Combo 2. UF‐Analog 3. HinsBet 1. Combo 2. UF‐Analog 3. HinsBet Adocia’s objective: Develop the next generation of ultra-fast insulin productsAdocia’s objective: Develop the next generation of ultra-fast insulin products
  • April 2014 Property of Adocia 21 • Design  36 Type I Diabetic patients  Double-blind 2-way cross-over design  BioChaperone Lispro (0.2 IU/kg) vs. Humalog (0.2 IU/kg)  PK & PD monitored for 6 hours after drug administration under euglycemic clamp • Main results:  BioChaperone Lispro has an onset of action 30% earlier than Humalog  BioChaperone Lispro has an early metabolic effect 69% stronger than Humalog  Both formulations of insulins (BioChaperone Combo and Humalog Mix) were well tolerated. • These results confirm the phase 1 results on healthy volunteers. Positive results of Phase IIa trial for BioChaperone Lispro Results on T1D confirm the strong potential of BioChaperone Lispro
  • April 2014 Property of Adocia 22 BioChaperone Lispro Mean Glucose Infusion Rate BioChaperone Lispro triggers its biological effect significantly earlier compared to Humalog® Full kinetic Zoom 0-2h BioChaperone Lispro
  • April 2014 Property of Adocia 23 BioChaperone Lispro Pharmacodynamics: Key Parameters BioChaperone Lispro has a significantly faster effect than Humalog with equivalent potency Mean (CV%) Parameter BioChaperone Lispro Humalog p‐value Tonset (min) 23.1 (30) 34.4 (45) <0.0001 TGIR‐max (h) 1.6 (43) 2.2 (34) 0.0002 AUCGIR 0‐30min (mg/kg) 38 (107) 12 (170) 0.001 AUCGIR 0‐1h (mg/kg) 218 (41) 129 (49) <0.0001 AUCGIR 0‐2h (mg/kg) 627 (38) 525 (41) 0.004 AUCGIR 0‐6h(mg/kg) 1 409 (35) 1 434 (35) 0.72 GIRmax (mg/kg/min) 7.9 (37) 8.0 (35) 0.76
  • April 2014 Property of Adocia 24 BioChaperone Lispro Mean (±SE) Pharmacokinetic Profile BioChaperone Lispro exhibit a faster-in and a faster-out of insulin lispro correlating with both a higher Cmax and with PD Full kinetics Zoom 0-2hBioChaperone Lispro
  • April 2014 Property of Adocia 25 BioChaperone Lispro Pharmacokinetics: Key Parameters All key PK parameters are significantly better with BioChaperone Lispro. The bioavailability of lispro is similar for both formulations. Mean (CV%) Parameter BioChaperone Lispro Humalog p‐value Early t[0.5max] (min) 17.4 (25) 29.0 (23) <0.0001 Tmax (min) 42 (27) 69 (31) <0.0001 Late t[0.5max] (min) 141.2 (31) 173.3 (24) <0.0001 AUC0‐30min (h*mU/L) 23.7 (48) 9.5 (65) <0.0001 AUC0‐1h (h*mU/L) 70.4 (40) 46.4 (45) <0.0001 AUC0‐last (h*mU/L) 218.5 (25) 217.1 (26) 0.8849 Cmax (mU/L) 102.6 (38) 90.4 (36) 0.0129
  • April 2014 Property of Adocia 26 • BioChaperone Technology enables the acceleration of any prandial insulin action • Proof-of-concept on Ultra-fast BioChaperone Lispro  Successful Phase 1 trial on 36 healthy volunteers  Successful Phase 1 trial on 36 type 1 diabetics • Product compliant with FDA and EMA guidelines on:  Stability and CMC section  Safety (3 month chronic tox in rat and dog) • Adocia has the full rights on ultra-fast acting BioChaperone insulin analogs BioChaperone Lispro Summary 1. Combo 2. UF‐Analog 3. HinsBet 1. Combo 2. UF‐Analog 3. HinsBet
  • April 2014 Property of Adocia 27 • Adocia intends to follow a short clinical development plan:  Go from Phase 1 studies to Phase 3 – reduced cost and time to market  Use a 505(b)(2) pathway in the USA • Phase 3 program could be launched based on these two positive phase 2 studies • We are working towards a pre-IND meeting with FDA and a scientific advice meeting with EMA in 2014 Ultra-fast BioChaperone Lispro Next Steps Adocia’s Ultra-fast insulin Lispro should benefit from a light clinical development 1. Combo 2. UF‐Analog 3. HinsBet 1. Combo 2. UF‐Analog 3. HinsBet
  • April 2014 Property of Adocia 28 • Human insulin represents a third of the total insulin market in volume and $3.1B in value  Mostly used in emerging markets due to cost-effectiveness  Important local players such as Biocon, Wockhardt, Gan & Lee • HinsBet, Adocia’s BioChaperone recombinant human insulin, achieves the same glycemic control as an insulin analog. • Human insulin price is approximately half the price of prandial insulin analogs (USA) HinsBet®: addressing the need for a cost-effective rapid-acting insulin Adocia’s fast-acting human insulin offers new perspectives for improving treatment in emerging markets 1. Combo 2. UF‐Analog 3. HinsBet 1. Combo 2. UF‐Analog 3. HinsBet Adocia’s objective: Accelerate Human Insulin’s action to achieve similar glycemic control to insulin analogs, at a lower cost Adocia’s objective: Accelerate Human Insulin’s action to achieve similar glycemic control to insulin analogs, at a lower cost
  • April 2014 Property of Adocia 29 • HinsBet was tested in Phase 1 and Phase 2a trials.  Excellent safety both on healthy volunteers and T1D (72 injections overall)  Acceleration of the onset of action of human insulin  Same onset of insulin action as NovoLog (insulin glulisine)  Light clinical development (505(b)(2) type) • Adocia has developed an optimized formulation of HinsBet which showed an even stronger performance in our preclinical model. • This new HinsBet will be tested in a Phase 2a starting 4Q14.  36 T1D patients  5 arms: Hinsbet (3 different doses) vs. Humalog (0.2 IU/kg) vs. Human insulin (0.2 IU/kg)  Double-blind, randomised, five-period crossover study under euglycemic clamp  Compare PK, PD profiles as well as study dose-exposure and dose-response HinsBet BioChaperone Human Insulin In emerging markets, Adocia intends to position HinsBet fast-acting human insulin as a new standard of prandial insulin 1. Combo 2. UF‐Analog 3. HinsBet 1. Combo 2. UF‐Analog 3. HinsBet
  • 1. Insulin therapy 2. Wound healing 3. DriveIn: nanotechnology for targeted delivery 4. Formulation of monoclonal antibodies Product Breakthroughs April 2014 30Property of Adocia
  • • Diabetic Foot Ulcer  Affects deep foot tissues  Due to the deleterious effects of diabetes on the nerves and blood circulation in lower limbs • Estimated 10 million people affected worldwide  More than 1 million people with diabetes require limb amputation each year  Morbidity of Diabetic Foot Ulcer is equivalent to colon cancer1 Diabetic Foot Ulcer (DFU): a life-threatening disease Neuroischemic DFU is a major healthcare burden orphan of treatment April 2014 31Property of Adocia 1 Armstrong, D. G. et al  Int Wound J 2007, 4 (4), 286‐287 • In western countries, DFU population is shifting from neuropathic DFU towards neuroischemic DFU, which is harder to treat 0 10 20 30 40 50 60 70 80 90 100 Five year mortality (%) Adapted from Int. Wound J. 2007, 4 (4), 286‐287
  • April 2014 Property of Adocia 32 Adocia targets the DFU advanced wound therapy market space There is a large market opportunity for biologics in advanced wound therapy of DFU. S&N ADOCIA Smith&Nephew,  DermaSciences Urgo, Convatec, Mölnlycke,  Systagenix…. ‐ + Severity of disease Cellular therapies ~ $10,000 Biologics ~ $1,500 Only approved product for  DFU: Regranex® (PDGF‐BB) Dressings  ~$200
  • April 2014 Clinical proof of concept established in Phase 1/2 on diabetic foot ulcer (India) BioChaperone PDGF Two Products for Two Markets Property of Adocia 33 • Application for a Phase 3 clinical  trial filed with the Indian Authorities  ‐ Higher efficacy ‐ Better convenience ‐ Cost control ‐ WHO‐GMP PDGF‐BB Emerging markets 80% neuropathic DFU ‐ Neuroischemic focus ‐ Higher efficacy and  convenience ‐ cGMP PDGF‐BB Western markets 60% neuroischemic DFU Status Next steps • Clinical development plan of DFU  treatment in Europe validated by the EMA • Preparation of a pre‐IND meeting with the  FDA (2Q14) • Launch of a Phase 3 clinical trial in Europe  (4Q14). • Study launch expected 2Q14
  • April 2014 Property of Adocia BioChaperone PDGF-BB Spray addressed all DFU market requirements 34 BioChaperone PDGF-BB spray meets the requirements for a first-line advanced wound care treatment BioChaperone PDGF-BB advantages • Targeting neuroischemic wounds • Easy to use and convenient  Applied once every two days (vs. daily for Regranex)  Ready-to-use spray  Sterile without preservatives  Multi-uses for 6 weeks  Stable up to 3 months at 30°C and 30 months at 5°C • Cost effective  1/3 of PDGF dosage vs. Regranex  Reduced cost of treatment due to reduced frequency • Safe
  • April 2014 35 Phase I/II clinical trial conducted in India on 192 mixed DFU patients  4 tested groups: 3 different doses of PDGF-BB compared with standard dose Regranex BioChaperone PDGF-BB established clinical efficacy in a Phase I/II study BioChaperone PDGF is non-inferior to Regranex at a third of the PDGF dose, and applied once every two days instead of daily Once a day Once every 2 days Property of Adocia Incidence of complete wound closure after 20 weeks 66%  79%  Registered in clinical under the #NCT01098357  
  • April 2014 Property of Adocia 36 • In the biologics field, competition on DFU is scarce:  The only existing treatment for neuropathic DFU is Regranex® (PDGF-BB)  DermaSciences develops angiotensin analog DSC127 (2 phase 3 in USA). Analysts estimate future peak sales of DSC127 (DermaSciences) at $400M in the US alone.1  Cell-based therapies are much more expensive. • BC PDGF-BB is the only product in development targeting neuroischemic DFU. • BC PDGF-BB was tested in a successful Phase 1/2 on mixed DFU in India • BC PDGF-BB will be developed for neuroischemic DFU in Europe and the US • Based on the medical need, EMA validated a shortened clinical development BioChaperone PDGF-BB for Western Markets Aiming at a first-line treatment for neuroischemic diabetic foot ulcer Large market opportunity for BC PDGF in DFU estimated at $300-600M 1. Source: LHA Investors, 2013 Adocia’s objective: Develop a first-line treatment for neuroischemic DFUAdocia’s objective: Develop a first-line treatment for neuroischemic DFU
  • 1. Wound healing 2. Insulin therapy 3. DriveIn: nanotechnology for targeted delivery 4. Formulation of monoclonal antibodies Product Breakthroughs April 2014 37Property of Adocia
  • April 2014 Property of Adocia 38 • Technology:  DriveIn is a unique targeted biomimetic nanotechnology allowing intracellular delivery • Dual Strategy:  Develop proprietary products based on generic Doxorubicin and Docetaxel.  Partner the technology with Big Pharma for their proprietary drugs in development. DriveIn: Targeted nanoparticles for Intracellular Drug Delivery in Oncology Adocia’s objective: Increase the efficacy of oncologic drugs by improving their delivery inside cancer cells Adocia’s objective: Increase the efficacy of oncologic drugs by improving their delivery inside cancer cells
  • April 2014 Property of Adocia 39 DriveIn Technology Approaching the Holy Grail in cancer drug delivery No targeting Active targeting Dynamic targeting and delivery Taxotere® Rubex® Doxil® Kadcyla® BIND‐014 DriveIn Systemic distribution Tissue/cell targeted Intracellular delivery Passive targeting Drug Hyaluronan surface DriveIn biomimetic strategy combines efficient targeting with enhanced cellular uptake
  • April 2014 Property of Adocia 40 • Most nanoparticles are coated with PEG: “stealth” approach.  PEG increases circulation time, but decreases cellular uptake.  Overall, efficacy is not increased. DriveIn : A biomimetic targeted nanoparticle DriveIn behaves as a Trojan Horse to drive and deliver the drug into cancer cells • DriveIn nanoparticles are coated with hyaluronan, the natural ligand of cellular receptors CD44:  CD44 receptors promote cellular internalization  Additionally, DriveIn nanoparticles present an improved drug PK profile  This combination should result in better efficacy. • Hyaluronan is a natural, biocompatible and biodegradable polysaccharide. Doxil® DriveIn Phase contrast Doxorubicin fluorescence Merged Cellular uptake
  • April 2014 Property of Adocia 41 Tumor growth inhibition Pre-clinical results of DriveIn Technology DriveIn-Doxorubicin First results in preclinical models support the potential of DriveIn to improve the performance of chemotherapy Increased survival In vivo: EAT Balb‐C mice after one injection of Dox/DriveIn‐Dox at 5mg/kg Control Doxorubicin DriveIn‐Dox Control Doxorubicin DriveIn‐Dox Reference: Kumar & al (2012) Nanomedicine: Nanotechnology, Biology, and Medicine 8:71–80
  • April 14 Property of Adocia - Non Confidential 42 • Versatile platform developed on two lead candidates: DriveIn-Docetaxel and DriveIn-Doxorubicin  Docetaxel (Taxotere®: $3.1B peak sales) and Doxorubicin (Rubex®, Doxil®: $402M, 2011) represent the two most used classes of cytotoxic drugs (Taxanes and Anthracyclins)  Both molecules have demonstrated their efficacy in a large range of cancers  Each of these DriveIn candidates has potential as an innovative and potent cancer therapy • Preclinical results with DriveIn-Doxorubicin candidates support:  Increased cellular uptake and durable intracellular localization  Decreased tumor progression and tumor burden in murine cancer models • Validation of the platform with Docetaxel is ongoing DriveIn versatile platform is designed to deliver the next generation of targeted oncology treatments Adocia intends to consolidate DriveIn strong potential
  • 1. Insulin therapy 2. Wound healing 3. DriveIn: nanotechnology for targeted delivery 4. Formulation of monoclonal antibodies Product Breakthroughs April 2014 43Property of Adocia
  • April 2014 mAbs Innovative Formulations 3 Complementary Approaches Four collaborative development programs on mAbs formulation are ongoing 1. To improve protein solubility and to reduce the formation of aggregates, especially for fusion protein, nanobodies, Antibody Drug Conjugates  BioChaperone technology 2. To reduce viscosity in highly concentrated mAbs solutions, thus facilitating subcutaneous injection:  Adocia Viscosity Reducer (AVR) technology  In vitro demonstration of superiority to arginine 3. To improve mAbs stability by avoiding the formation of interface-induced aggregates:  Adocia Stabilizer (AS) technology  In vitro demonstration of superiority to polysorbates Property of Adocia 44
  • April 2014 Financial Statements Property of Adocia 45
  • April 2014 Property of Adocia 46 • Revenues: €8.8M in 2013 compared to €7.2M  Revenues: €5.6M in 2013 versus €4M in 2012  R&D tax credit: €3.2M in 2013 versus €3.2M in 2012 • Cash position: €19.4M end of December 2013 • Burn rate 2013: €11.1M • Long term debt: €2M loan from BpiFrance to support projects development Reimbursable only in case of success 2013 results: published key figures Robust financial position @ €19.4M beginning January 2014
  • • Listed on Euronext Paris since February 2012 • 6.2 million shares, with a float of 24% • Market cap : €72 M end of • Cash: €19.8M end of December 2013 • Analysts :  Dexia (Lionel Labourdette)  Invest Securities (Daniel Anizon)  Bryan, Garnier & Co. (Cédric Moreau/David Serrero)  Life Sci Advisors (Andrew I. Mc Donald) Shareholders as of December 2013 Shareholders equity April 2014 47Property of Adocia (*) including, if any , shares hold by historical investors of the Company.
  • Adocia – In summary April 2014 48Property of Adocia
  • April 2014 Property of Adocia 49 • BioChaperone clinical proof-of-concept demonstrated in all the insulin portfolio  BioChaperone Combo  Ultra-fast BioChaperone Lispro  HinsBet  3 new Phase 2 trials planned in 2014 • BioChaperone PDGF-BB ready to begin Phase III in India, with accelerated development pathway planned in EU • Two additional mAb collaborations launched in 2014 • €19.3 M Cash position allowing to pursue portfolio development until mid-2015  Burn-rate 2013: €11 M Adocia - In Brief
  • April 2014 Property of Adocia 50 Adocia – What to look forward to Product /  Technology  Therapeutic area Status Expected  timeline Key advantages BioChaperone PDGF‐BB Diabetic Foot  Ulcer Indian Phase III Launch 2Q14  ‐ Low dose, convenient, efficient ‐ Pharmaco‐economic rationale Ultra‐fast  Analog Diabetes Second European Study Phase IIa Results 3Q14 ‐ Improved glycemic control ‐ Towards an artificial pancreas ‐ Adaptable to any analog Insulin Combo Diabetes Second European Study  Phase IIa Results 4Q14 ‐ Convenience and efficacy ‐ Breakthrough product ‐ Glargine‐based HinsBet Diabetes European Phase IIa Launch 4Q14  ‐ Analog‐like efficacy ‐ RHI‐like cost DriveIn Oncology Phase I Launch 1Q15 ‐ Intracellular delivery ‐ Targeted nanotechnology mAbs technologies Depending on  partner Ongoing collaborative developments ‐ ‐ Efficiently covering a range of  mAb‐related issues ‐ Easy to manipulate 
  • Contact SA au capital de 619.227,60 € - RCS Lyon 487 647 737 00021 Tél + 33 4 72 610 610 115 avenue Lacassagne – 69003 Lyon Thank you for your kind interest April 2014 51Property of Adocia