PART 2: PRODUCT PIPELINE. Investor & Press Presentation Paris, 11th March 2009

Transcription

1 PART 2: PRODUCT PIPELINE Investor & Press Presentation Paris, 11th March 2009

2 Cautionary note regarding forward-looking statements This presentation contains forward-looking statements referring to the planned clinical testing and development of Transgene s therapeutic vaccine candidates, and the possible entry into new partnership agreements.. However, clinical testing and successful product development depend on a variety of factors, including the timing and success of future patient enrolment and the risk of unanticipated adverse patient reactions. Results from future studies with more data may show less favorable outcomes than prior studies, and there is no certainty that product candidates will ever demonstrate adequate therapeutic efficacy or achieve regulatory approval or commercial use Furthermore, the entry into new partnerships involves a process of negotiation with partner candidates, including with respect to financial, technical, commercial and legal matters, and there is no certainty that appropriate partnerships will be established or will be successful.. For further information on the risks and uncertainties involved in the testing and development of Transgene s product candidates, see Trangene s Document de Référence on file with the French Autorité des marchés financiers on its website at and Transgene s website at

3 TABLE OF CONTENTS Slide 1. Key Events 4 2. Product Update Pipeline Summary 5 TG4010 (NSCLC) 6 TG4040 (HCV) 22 TG4001 (HPV) 25 TG1042 (Onco-Dermatology) 28 TG4023 (HCC and mcrc) Business Outlook Pipeline News Flow 38 3

4 Summary of Key Events New Management New Strategy Portfolio Refocus 34.9m capital increase Positive results Phase I/II CBCL/CTCL trial (TG1042) Promising TG4010 phase IIa results in solid tumors 14.3m raised (warrants exercised) Launched phase IIb trial in NSCLC (TG4010) Positive phase II results in HPV trial (TG4001) Partnership with Roche 100m capital increase Launch of Phase I in HCV (TG4040) Recruitment for Phase II trial in NSCLC and CBCL Conclusion: A substantial reinforcement of the company Roche partnership validates strategy and technology Cash position covers some 3 years of operations Refocus of product portfolio delivering desired clinical results 18m OSEO grant Biomarker program Phase IIb NSCLC trial for TG4010 meets primary endpoint Start of partnership discussions for TG4010 franchise Phase II CBCL trial meets primary endpoint Seeking partner for TG1042 franchise Positive Phase I preliminary results from HCV trial France (TG4040) Launch 2 nd phase I trial for HCV (TG4040) in Canada 4

5 Portfolio of Products in Development PRODUCT Indication Preclinical Phase I Phase II Phase III Partnership Strategy TG4010 (MVA-MUC1-IL2) Non Small Cell Lung Cancer Currently seeking a Partner TG4001/R3484 (MVA-HPV-IL2) Treatment of precancerous lesions of the cervix caused by the HPV virus TG1042 (Ad-IFNγ) Cutaneous B Cell Lymphoma Seeking partnership in broader oncodermatological franchise. TG4040 (MVA-HCV) Chronic Hepatitis C Sole development up to proof of concept TG4023 (MVA-FCU1) Metastatic Colerectal Cancer Hepatocarcinoma Sole development up to proof of concept 5

6 TG4010 a Promising Vaccine to fight Cancer CONSTRUCTION AND MECHANISM OF ACTION TARGET MARKET MVA + MUC1 + IL2 immunogenic vector tumoral antigen cytokine adjuvant A targeted immunotherapy for the treatment of MUC1 positive tumors First line treatment of metastatic non small cell lung cancer (NSCLC) in combination with chemotherapy Other NSCLC stage of diseases and all epithelial cancers expressing MUC1 (prostate, breast, kidney etc.) Sub-cutaneous injection 6

7 TG4010 / MVA-Muc1-IL2 MUC1 Protein Definition - Expression In Major Cancers 90% 60% 60% 75% MUC1+ MUC1+ MUC1+ MUC1+ Breast cancer Lung cancer Metastatic Prostate cancer Kidney cancer 70% 80% 90% 90% MUC1+ MUC1+ MUC1+ MUC1+ Colorectal cancer Stomach cancer Myeloma cancer Pancreas cancer 7

8 TG4010: A Wide Range of Potential Indications Addressable Population Unmet Need Selection of potential Sub-indications Annual Incidence (EU / US / Japan) Disease burden, recent drug approvals NSCLC IIIB/IV Prostate Cancer Hormone Refractory Prostate Cancer Early Stage I & II NSCLC IIIA unresectable ~ ~ ~ ~ High High Low Moderate Colorectal Cancer Advanced Stage IV ~ Moderate Breast Cancer Advanced Pancreatic Cancer - Advanced ~ ~ High High Breast Cancer Early Stage 0, I, II ~ Moderate 8

9 TG4010: Global NSCLC Incidence NSCLC Incidence data (ww) No of Patients, 000 US Europe Japan Other Developed countries ~40% of global Incidence 67 NSCLC: the cancer with the highest incidence: >1.3m Developed countries are weighting ~40% of global incidence Source : Globocan, National Cancer Institute, L.E.K. interviews & analysis 9

10 TG4010: Global Lung Cancer Mortality Lung cancer = NSCLC (80%) + SCLC (20%) Highest mortality among cancers: 1.18 million deaths/yr. ~25% of all cancer deaths worldwide (more than colon, breast and prostate cancers combined) Europe: 334,800 deaths in 2006 [Ferlay J et al. Annals of Oncology Advance Access, Feb 7, 2007] 253,300 men, representing 27% of total cancer deaths 81,500 women, representing 11% of total cancer deaths USA: 160,390 deaths in 2007 [National Cancer Institute] 161,840 deaths expected in 2008: 90,810 men and 71,030 women Lung cancer is the leading cause of cancer deaths in both men and women (worldwide) 10

11 TG4010: Therapeutic Intervention Points (TIP) for NSCLC NSCLC NSCLC Stage Stage IA IA Stage Stage IB IB Stage Stage II II Stage Stage IIIA IIIA Stage Stage IIIB IIIB Stage Stage IV IV Resectable Resectable Cancer Cancer Unresectable Unresectable Cancer Cancer Performance Performance Status Status = = Performance Performance Status Status = = Surgery Surgery Surgery Surgery Surgery Surgery Surgery Surgery Chemoradiation TIP 2 Platinum-based Chemotherapy + bevacizumab (~30-40% of patients eligible for bevacizumab ) TIP 3 Platinum-based Adjuvant Chemotherapy + Radiation TIP 1 2 nd Line Treatment (Tarceva, Alimta, Taxotere) TIP 4 3rd Line Treatment (Tarceva, Taxotere) TIP 5 Observation Observation with with follow-up follow-up Observation Observation with with follow-up follow-up No Recurrence Yes Return Return to to Tx Tx path path No Recurrence Yes Supportive/ Supportive/ Palliative Palliative Care Care Chemotherapies Gemzar/ Taxol/ Navelbine/ Alimta Targeted therapies // Add-on Erbitux / Merck TG4010/ Transgene Avastin / Genentech 11

12 TG4010: Histological Types of Lung Cancers Small cell anaplastic carcinomas (SCLC): Agressive and invasive Early metastasis SCLC 20% Adenocarcinomas: Large cell carcinomas: Same outcome as adecarcinomas 10% NSCLC 25% 45% Glandular cell nonanaplastic carcinomas including bronchial carcinoïds Incidence Squamous cell carcinomas: Epidermoid and non-anaplastic carcinomas Incidence NSCLC represent ~ 80% of Lung cancers NSCLC is a heterogeneous aggregate of histologies: the most common histologies are adenocarcinoma epidermoid, squamous cell carcinoma and large cell carcinoma These histologies are often classified together because approaches to diagnosis, staging, prognosis and treatment may in some cases be similiar 12

13 TG4010: Competitive Product Positioning in Metastatic (IIIb/IV) NSCLC Gemzar/Alimta (Ely Lilly) Navelbine (Pierre Fabre) Taxol (Bristol Myers) Erbitux (Merck) Gemzar (Ely Lilly) Taxol (Bristol Myers) Navelbine (Pierre Fabre) Erbitux (Merck) 31% Others 13% Squamous cell carcinoma Adenocarcinoma 56% Current chemotherapies Other therapies Gemzar/Alimta (Ely Lilly) Navelbine (Pierre Fabre) Taxol (Bristol Myers) Avastin (Genentech) Erbitux (Merck) Ref: Scagliotti study (JCO July 2008), FLEX study (ASCO 2008), ECOG4599 retrospective analysis (JTO 2008 suppl #4) Avastin is clearly positioned in Adenocarcinoma NSCLC segment and not in Squamous cell carcinoma (~56% of NSCLC) Erbitux is positioned on all NSCLC segment 13

14 TG4010: First Line Treatments for mnsclc Phase II Results Drug bevacizumab (Avastin) cetuximab (Erbitux) pemetrexed (Alimta) gemcitabine (Gemzar) Patient population non Squamous tumor EGFR detectable tumor Adenocarcinoma Squamous cell carcinoma Combined chemotherapy paclitaxel carboplatin vinorelbine cisplatin cisplatin cisplatin OverallSurvivalin control arm (months) (skin rash patients) 10.9* 9.4 ** OverallSurvivalin experimental arm (months) (skin rash patients) * Comparison arm = gemcitabine/cisplatin ; ** comparison arm= pemetrexed/cisplatin So far clinical results are demonstrating ~+ 2 months median overall survival Cetuximab, with some selected patients (skin rash), is reaching ~ 6 months median overall survival ( ~similar to TG4010) 14

15 TG4010 Clinical Development Strategy Phase IIa Exploratory Phase IIb Partnership Phase III Lung & other Indications Registration Commercialization Non Small Cell Lung Cancer Prostate Breast Kidney Non Small Cell Lung Cancer TRANSGENE OBJECTIVES Non controlled clinical trials 184 patients included Indication of efficacy in different settings. Decision to make POC study in first line treatment of NSCLC in combination with chemotherapy Objectives of trial: Assess efficacy of TG4010 combined with chemotherapy in patients with advanced NSCLC 148 patients 27 centres in Europe Stage IIIb (8%) Stage IV (92%) Combined with gemcitabine / cisplatine Large Biomarker program in progress 15

16 TG4010: PFS at 6 months (ITT population cut off date: Jan 09) Whole Study population (148 pts) Patients with normal level of activated NK cells at baseline (101 pts) % TG chemo Chemo Percentage (%) % 35% 26 TG chemo Chemo Percentage (%) % Number of patients (Total of 74 patients per arm) 0 PFS 6 months (central review) p=0.3 Number of patients (Total of 48 patients for TG chemo and total of 53 patient for chemo) 0 PFS 6 months (central review) p=0.065 ITT analysis, central review, evaluation every 6 weeks (WHO criteria) 16

17 TG4010: Response Rate (ITT population cut off date: Jan 09) Whole Study population (148 pts) Patients with normal level of activated NK cells at baseline (101 pts) % TG chemo Chemo Percentage (%) % 28% 21 TG chemo Chemo Percentage (%) % Number of patients (Total of 74 patients per arm) 10 0 Response rate (central review) Number of patients (Total of 48 patients for TG4010+chemo and total of 53 patients for chemo) 10 0 Response rate (central review) p= 0.08 p=0.008 ITT analysis, central review, evaluation every 6 weeks (WHO criteria) 17

18 TG4010:Time to Progression (ITT population cut off date: Jan 09) F rac tion of Patient Population N ot Progres s ing 100% 50% TG : TIME TO PROGRESSION IN ALL POPULATION Arm1: TG CT Arm2: CT ALONE n=148 HR= 0.72 [95% CI : ] Log-Rank test*: p=0.08 *stratified for tumor stage and PS at baseline. med surv = 5.9 mos [95% CI: ] n=74 med surv = 5.2 mos [95% CI: ] n=74 0% Time To Progression (months) Complete Censored F rac tion of Patient Population N ot Progres s ing 100% 50% TG : TIME TO PROGRESSION IN PATIENTS WITH NORMAL ank LEVELS med surv = 4.7 mos [95% CI: ] n=53 0% Time To Progression (months) Arm1: TG CT Arm2: CT ALONE n=101 HR= 0.58 [95% CI : ] Log-Rank test*: p=0.007 med surv = 6.3 mos [95% CI: ] n=48 Complete Censored TTP between Arm 1 (TG chemotherapy) and Arm 2 (chemotherapy) is statistically in favor of Arm 1 in patients with normal levels of activated NKcells at baseline 18

19 TG4010: Overall Survival (ITT population cut off date: Jan 09) F r a c tio n o f P a tie n t P o p u la tio n S u r v iv in g 100% 90% 80% 70% 60% 50% 40% 30% 20% TG : ALL POPULATION, ARM1 vs ARM2 med surv = 10.3 mos (n=74) ARM 1: TG CT ARM 2: CT ALONE n=148 HR=0.88 [95% CI: ] p=0,438 med surv = 10.7 mos (n=74) F rac tion of Patient Population Surv iv ing 100% 90% 80% 70% 60% 50% 40% 30% 20% TG : PATIENTS WITH NORMAL ank LEVELS med surv = 11,3 mos (n=53) ARM 1: TG CT ARM 2: CT ALONE n=101 HR=0.58 [95% CI: ] p=0,02 med surv = 17,05 mos (n=48) 10% 0% Complete Censored Survival(months) 10% 0% Complete Censored Survival (months) Median survival is statistically in favor of Arm 1 (TG chemotherapy) compared to Arm 2 (chemotherapy) in patients with normal levels of activated NK cells at Baseline 19

20 TG4010 Phase IIb Results to Date Safety & Efficacy Experimental Arm (TG chemo) n=74 Control Arm (chemo) n=74 Comments Safety Good (most related adverse events are injection site reaction and asthenia) N/A Classical vaccination reactions. Quality of Life not statistically different between arms Progression Free Survival at 6 months Whole study population Patients with normal level of activated NK cells at baseline* 43% 56% 35% 38% Primary end point met Not statistically significant difference (p= 0.06) Response Rate Whole study population Patients with normal level of activated NK cells at baseline* 42% 54% 28% 28% Not statistically significant difference (p=0.08) Statistically significant difference (p=0.008) Time to Progression Whole study population Patients with normal level of activated NK cells at baseline* 5.9 months 6.3 months 5.2 months 4.7 months HR: 0.72 [95%CI: ] (p=0.08) HR: 0.58 [95%CI: ] (p=0.007) Whole study population 10.7 months 10.3 months HR: 0.88 [95%CI: ] Median Survival HR: 0.58 [95%CI: ] Patients with normal level of Large biomarker program ongoing activated NK cells at 17.1 months 11.3 months aimed at defining mode of action, and baseline* contribute to Phase III design *Patients with normal level of activated Natural Kill Cells at baseline represent 101 of the 138 patients evaluable for immunology analysis with respectively 48 in the experimental arm and 53 in the control arm 20

21 TG4010 Conclusion Phase IIb RESULTS ALLOW US To pursue the next development steps toward registration in advanced NSCLC To negotiate a partnership agreement covering multiple indications FURTHER RESULTS ARE DUE IN Q Include overall survival Full biomarker program analysis 21

22 TG4040 Treatment of Hepatitis C CONSTRUCTION AND MECHANISM OF ACTION TARGET MARKET MVA + NS 3/4/5B immunogenic vector Non structural antigens of the HCV virus 170 million people infected wordwide 12 million people infected in Europe, North America and Japan (genotype 1) A targeted immunotherapy for the treatment of chronic carriers of Hepatitis C Virus Sub-cutaneous injection Standard of treatment Combination with pegylated interferon alpha and ribavarin 48 weeks of treatment Effective in only 50% of genotype 1 cases Major side effects 22

23 TG4040 Clinical Development Strategy PHASE I FRANCE EXTENSION PHASE I PHASE I CANADA 15 patients 27 patients 24 patients Treatment naive Escalating dose 3 initial injections Boost injection at 6 months at highest dose Earlier boosts at 2 and 4 months With more advanced liver disease (2N<ALT<5N) Relapsers after SCT Escalating doses 3 initial injections 1 boost after 6 months Interim Results (March 2009): Good Safety Additional Results (March 2009) Good safety: All studied doses were safe and well tolerated viral load reduction (0.5 log 10 to 1.4 log 10 ) in 6 out of 15 patients encouraging preliminary immunological analysis FINAL RESULTS Q FINAL RESULTS EXPECTED END

24 TG4040 Conclusion The most comprehensive ongoing therapeutic vaccine development program targeted to treat HCV Interim results show evidence of coincident viral load decrease and mounting vaccine-specific immune responses Further data (clinical, Immunological) to be published in Q2, 2009 We intend to initiate phase II trial in combination with SOC, in late 2009 / early

25 TG4001/R3484 A Promising Treatment for Diseases Caused by the HPV Virus CONSTRUCTION AND MECHANISM OF ACTION MVA + HPV16 + IL2 E6 & E7 immunogenic vector antigens A targeted immunotherapy for the treatment of diseases caused by Human Papilloma Virus (HPV) Sub-cutaneous injection cytokine adjuvant TARGET MARKET Prevention of uterine cancer through the treatment of severe precancerous cervical lesions (CIN2/3) caused by HPV16 virus HPV infection: common sexually transmitted disease 900,000 new cases of women with severe lesions are diagnosed each year (EU/US) 50% a target for TG4001/R3484 Potential in other genotypes related to type 16. Exploratory studies to be conducted on CIN1 positive women and patients with cervical cancer Current Treatments Spontaneous clearance in less than a year (70% of cases) CIN2/3 lesions treated via surgery Side effects: bleeding, miscarriage, infertility Significant relapse rate (37%) 25

26 TG4001/R3484: PARTNERED WITH ROCHE A WORLD CLASS PARTNERSHIP AGREEMENT WITH Exclusive world-wide rights to TG4001/R3484 franchise Substantial income flow Phase IIa Phase IIb Phase III Filing Registration Commercialization Signature April 2007, 23m Payment Payment of additional development milestones Up to 195m in various indications Further payments tied to sales targets Progressive double digit royalties on sales Commercial supply of vaccines to Roche 26

27 TG4001 Current Status Roche activities related to start of controlled phase IIb trials in both Europe/US are progressing as planned. Commercial Manufacturing Agreement: Term Sheet discussion initiated. 27

28 TG1042 Immunotherapy for Dermatological Cancers CONSTRUCTION AND MECHANISM OF ACTION TARGET MARKET Adenovirus + IFNγ E1 E3 - deleted vector Gene expressing IFNγ Local stimulation of the immune system through production of interferon gamma (local sustained expression) Intralesional injection into tumors Oncology Indications Cutaneous Lymphomas (CBCL / CTCL) Basal Cell Carcinoma (nbcc) Melanoma Bladder Cancer Onco-dermatology nbcc incidence: % population in developed countries Melanoma incidence: Globally new cases per year Prevalence high in developed countries and steadily increasing Current standard of care: Surgery & Chemotherapy CBCL prevalence: 10 to patients EU/US 28

29 TG1042 Clinical Development and Commercial Strategy Phase I/II Preparation Phase II Phase II Step 1 Phase II Step 2 Filing / Registration Commercialization 33 patients CTCL CBCL 13 patients CBCL Seeking collaborative partnership in broader onco-dermatological franchise RESULTS DEC Good safety Response rate CTCL: 46% (n=26) Response rate CBCL: 100% (n=5) PHASE II Step 1 RESULTS Nov Primary end point met Response rate: 10 out of 12 evaluable patients Good safety DSMB conclusion positive 29

30 TG1042 Adenoviral Platform Current Status and Next Steps Positive phase II step 1 results in CBCL- Favorable recommendation by independent DSMB Preclinical results in other indications and clinical results of TG1024 (Adeno IL2) promising Market analysis and medical positioning ongoing for nbcc Considering scope of possible franchise new development strategy likely to be decided with a partner Business development update in H

31 TG4023 A Unique Approach Combining Immunotherapy and Targeted Chemotherapy CONSTRUCTION AND MECHANISM OF ACTION TARGET MARKET MVA + FCU1* Immunogenic vector Suicide Gene *FCU1 = Bifunctional chimeric enzyme (Cdase;UPRTase) FCU1 converts the prodrug 5-FC (5-Fluorocytosine) into 5-FU (5-Fluorouracil) TG4023 is a gene-directed therapy which may increase the efficacy of chemotherapy in solid tumors accessible to intra-tumoral injection Intra-tumor/metastasis injection in combination with lower dose systemic chemotherapy Treatment of cancerous lesions of the liver: Primary liver tumors: hepatocellular carcinomas (HCC) Liver metastasis of other cancers, mainly colorectal cancer (mcrc) Market potential Hepatocarcinoma 500K+ new cases p.a. 60% of patients not operable Colorectal cancers 1m new cases p.a; 60% of patients develop liver metastasis 80% of patients non resectable Medical Need High Increase cure rate of HCC and mcrc patients and prolong survival of inoperable patients 31

32 TG4023 A Targeted Chemotherapy TG4023 = MVA + FCU1 immunogenic vector suicide gene 5-FC non cytotoxic Cytosine Deaminase (CDase) 5-FU toxic FCU1 5-FUMP toxic Uracil PhosphoRibosylTransferase (UPRTase) FCU1 = bifunctional chimeric enzyme 5-FC: 5-Fluorocytosine 5-FU: 5-Fluorouracil

33 TG4023 Product Description and Rationale What is 5-FU? Chemotherapy with strong clinical practice background (since 1957) Remains the cornerstone of chemotherapy It is low in efficacy and high in toxicity Short half life > need for continuous infusion No oral administration of 5-FU 5-FU (IV, IP, IHA) Systemic 5-FU Systemic Toxicity of 5-FU Product Rationale for TG4023: TG4023 aims at delivering 5-FU in the tumor It aims to improve 5-FU efficacy while abrogating its systemic toxicity Targets all solid tumors accessible to IT injections in combination with lower dose chemotherapy New option for patients with non-operable tumor/metastases New option for patients non eligible for local ablation techniques New option for patients after chemo. failure 5FU 5-FC (oral, IV) TG4023 TG4023 (IT) No systemic toxicity of 5-FU High intra-tumoral concentration 33

34 TG4023 Mechanism of Action FCU1 converts the prodrug 5-FC into 5-FU, resulting in: Sustained (15 days) and high level of in situ production of 5-FU (at a concentration not attainable through systemic administration of 5-FU) Efficacy against neighboring tumor cells that do not express the FCU1 gene through a bystander killing effect 1% infected cells is sufficient to kill the whole cell population 5-FU can diffuse by nonfacilited diffusion into adjacent cells Possible activation of the immune system through cell killing and presence of the virus 5-FU 5-FU 5-FC 5-FU FCU1 gene 5-FUMP 5-FU 5-FU 5-FU 5-FU 5-FU 34

35 TG4023 Preclinical Proof of Concept (2) In vivo results: The anti-tumor effect of TG4023 was demonstrated in nude mice after subcutaneous injection of human tumor cells (colon cancer, liver cancer and glioblastoma). Significant control growth tumor observed in mice treated with TG FC compared to control mice treated with systemic 5-FU. Mean Tumor Volume (mm 3 ) +/-SEM Saline Saline/5-FU MVA-FCU1/saline MVA-FCU1/5-FC 5-FU 100 MVA- FCU1/5- FC Days Post Tumor Implant Nude mice implanted with human colon cancer cells.

36 TG4023 Clinical Development Strategy Preclinical studies provide encouraging data to support future clinical development In vitro and in vivo results, including biological and toxicological studies, suggest a favorable safety profile of TG4023 In conclusion it is a promising, safe candidate for a targeted chemotherapy approach in the treatment of hepatic metastasis We anticipate Phase I entry Q Further details will be provided at product entry into the clinic 36

37 Outlook Comfortable cash position Partnership which allows us to execute Phase IIa Phase IIb Phase III our strategy and accelerate development of our pipeline Phase IIa Exploratory Focus on signing a partnership agreement for TG4010 Adding one new product to the pipeline, TG4023 Preparing for a phase II in HCV within one year Strategic update on our onco-dermatological franchise in H Phase IIb entry for TG4001/R3484 Lower operational cash burn at 20 Million in

38 PIPELINE NEWSFLOW (provisional) R&D OUTLOOK Q1 TG4010 (NSCLC): Phase II median survival data Strong pre-clinical pipeline with a large program in virology Q2 TG4040 TG4010 (NSCLC) TG4001/R3484 (HPV) TG4010 (NSCLC) TG Annual results Phase I (France) and next steps Phase II final results Phase IIb launch Expected partnership Bring one new product into clinic yearly Adjuvant, TLR agonists to further strengthen viral based vaccines Mab against well characterized receptor Q3 Q4 TG4023 (HCC & mcrc): TG4040 (HCV): TG1042 (oncodermato): Phase I entry & strategic positioning Phase I results extension (France) Update strategic positioning Cell line for viral production TG4040 (HCV): Final results phase I Canada Expected entry into phase II 38

39 Contacts Philippe Archinard, CEO Philippe Poncet, CFO Elisabetta Castelli, Director IR