Transgene SA · EURONEXT:TNG
Transgene SA — FY2017 Earnings Presentation
41 slides from Transgene SA's earnings presentation, Mar 21, 2018
Slide 1: Virus-based immunotherapies to transform the fight against cancers and infectious diseases
Virus-based immunotherapies to transform the fight against cancers and infectious diseases March 21, 2018 FY Results 2017 & Business update
Slide 2: Disclaimer
Disclaimer This presentation contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. There can be no guarantee that (i) the results of pre-clinical work and prior clinical trials will be
Slide 3: Transgene | Poised to play a key role in immunotherapy
Transgene | Poised to play a key role in immunotherapy Focus on cancers and infectious diseases: A pioneer in developing viral vector-based • High level of unmet medical need immunotherapies • New treatments leave significant opportunities 2 5 Cutting-edge immunotherapy platforms Immunotherapy produ
Slide 4: Cutting-edge molecular virology applied to Immuno-Oncology
Cutting-edge molecular virology applied to Immuno-Oncology Therapeutic vaccines Oncolytic Viruses • Broad and sustained anti-tumor • Sustained anti-tumor response via response immunogenic cell death • Targeted response against selected TAAs • Increase infiltration of T and NK cells • Increase CD4+ a
Slide 5: 2017 | Key achievements across all of our clinical programs
2017 | Key achievements across all of our 5 clinical programs Therapeutic vaccines Oncolytic Viruses TG4010 – lung cancer Pexa-Vec – solid tumors ✓ 1L and 2L* trials in combination with ICIs ✓ Progress of Phase 3 in HCC 1L initiated ✓ Pexa-Vec + nivolumab trial in HCC 1L started ✓ Clinical collabora
Slide 6: 2017 | Invir.IO platform launch
2017 | Invir.IOTM platform launch Leading the way in multifunctional OVs Transform the fight against cancer • Enhanced modulation of the tumor micro- Designing the next generation of environment (TME) multifunctional oncolytic viruses • Insert a range of transgenes that will be expressed in the TME
Slide 7: 2017 | Research collaborations based on broad OV expertise
2017 | Research collaborations based on broad OV expertise Application of viral vectors technology Application of viral vectors technology to to the engineering of allogenic CAR-T the design of multifunctional OVs – Two collaborative developments signed • Evaluate and select innovative vectors for t
Slide 8: 9 clinical trials to readout in 2018
9 clinical trials to readout in 2018 Preclinical Clinical Phase Product Indication 1 2 3 THERAPEUTIC VACCINES Non-small cell lung cancer – stage 4 1st line + nivolumab (ICI) + CT TG4010 Non-small cell lung cancer – stage 4 2nd line + nivolumab (ICI) Non-small cell lung cancer Neo-adjuvant (translati
Slide 9: TG4010 in non-small cell lung cancer (NSCLC)
TG4010 in non-small cell lung cancer (NSCLC) Clinical development update
Slide 10: Lung cancer | Better therapeutic options still needed
Lung cancer | Better therapeutic options still needed for non-responders (ICIs) First-line therapy Dismal prognosis • Pembrolizumab registered at late stage – in 2016 for patients whose tumor cells express high levels of PD-L1 (≥ 50 %) – in 2017 for all patients, in combination with pemetrexed/ Need
Slide 11: TG4010 | Clinical development plan (non sq. NSCLC)
TG4010 | Clinical development plan (non sq. NSCLC) Positive results from 1st line trial would put us in a strong competitive position • Multi-center Phase 2 trial in US and Europe TG4010 • BMS to supply nivolumab NSCLC - 1st line + chemotherapy • Sponsor: Transgene patients with no or low level • US
Slide 12: TG4001 & TG1050 therapeutic vaccines
TG4001 & TG1050 therapeutic vaccines Clinical updates
Slide 13: TG4001 & TG1050 | Ongoing trials to deliver results in 2018
TG4001 & TG1050 | Ongoing trials to deliver results in 2018 TG4001 – HPV+ head & neck cancer TG1050 – Chronic hepatitis B Clinical collaboration with Merck/Pfizer, First part of the results featured at the AASLD supply of avelumab (ICI) (October 2017) Phase 1b/2 trial Phase 1b trial • PI: Prof. Chri
Slide 14: Oncolytic Viruses – Pioneered by Transgene
Oncolytic Viruses – Pioneered by Transgene A new and highly promising therapeutic class in the fight against cancer. Transgene leading the development of multifunctional OVs for the enhanced modulation of the TME via a single therapeutic.
Slide 15: Oncolytic viruses (OVs) | An attractive therapeutic family
Oncolytic viruses (OVs) | An attractive therapeutic family Rapidly growing interest from big Pharma in this exciting therapeutic approach • One approved product (HSV strain) - There’s interest from Big Pharma Amgen in this field. There is a growing • Most players are still working on view that oncol
Slide 16: Oncolytic viruses | Attack tumors on several fronts
Oncolytic viruses | Attack tumors on several fronts ❷ Immunogenic cell death, proinflammatory response, and induction of both innate & Tumor cell lysis induced ❶ adaptive immune responses after specific viral replication in tumor cells ❸ Local release of active payload in the TME « Warming up » of
Slide 17: Oncolytic viruses | Towards enhanced TME modulation
Oncolytic viruses | Towards enhanced TME modulation FUTURE GENERATIONS Innovative NEW GENERATION content TG6002 • Oncolytic activity • Systemic (IV) administration • Better tumor selectivity Imlygic/T-Vec, Pexa-Vec • Oncolytic activity (double gene deletion) • Systemic (IV) administration • “Armed”
Slide 18: Pexa-Vec Targeting solid tumors
Pexa-Vec Targeting solid tumors Replicative Vaccinia Virus expressing GM-CSF
Slide 19: Pexa-Vec | Lead oncolytic virus
Pexa-Vec | Lead oncolytic virus Ongoing pivotal Phase 3 trial in HCC 1L Global clinical development plan • SillaJen responsible for conducting Phase 3 trial • Transgene own all rights for its territory HCC 1L Other solid tumors • Transgene’s remaining funding obligation amounts to $1.5 million for t
Slide 20: Pexa-Vec | Large unmet medical need in HCC
Pexa-Vec | Large unmet medical need in HCC First-line therapy • Sorafenib is currently the only approved product - modest activity Dismal prognosis – ORR: 2% ; median OS: 10.7 months • Nivolumab could become a new therapeutic option: Promising activity Better therapeutic in Phase 3 (still ongoing) o
Slide 21: Pexa-Vec | Clinical development plan in HCC - 1st line
Pexa-Vec | Clinical development plan in HCC - 1st line Pivotal Phase 3 and combination Phase 2 Position Pexa-Vec with current and future standard of care • Multi-center Phase 3 trial in Europe, US, Asia Advanced HCC Pexa-Vec Conducted by • Randomized, two-arm trial 1st line + sorafenib • Ongoing re
Slide 22: Pexa-Vec | Exploratory clinical trials to deliver results in 2018
Pexa-Vec | Exploratory clinical trials to deliver results in 2018 Led by Transgene in Europe Pexa-Vec + Yervoy® • Centre Léon Bérard (France), sponsor of the trial Solid tumors (ipilimumab) • 1st patient dosed in February 2017 • Institut Bergonié (France), sponsor of the trial Breast cancer Pexa-Vec
Slide 23: TG6002 | Advanced OV already in the clinic
TG6002 | Advanced OV already in the clinic • 100% owned by Transgene Viral oncolysis + local production of chemotherapy • Additional functionality with FCU1 gene Cell chemotherapy Prodrug Cytotoxic drug death activating 5-FU Prodrug enzyme 5-FC • First-in-human • Single-center Phase 1 trial • Multi-
Slide 24: Engineering multifunctional oncolytic viruses
Engineering multifunctional oncolytic viruses Based on large capacity Vaccinia Virus
Slide 25: Invir.IO | Attack tumors on several fronts
Invir.IOTM | Attack tumors on several fronts Combines several MoAs Enhanced modulation of TME Favoring tumor infiltration ❶ Tumor cell lysis induced Unlocking local after specific viral replication immunosuppression in tumor cells Proinflammatory response, and induction of both immune ❷ Immunogenic
Slide 26: Invir.IO | Engineer multifunctional oncolytic viruses
Invir.IO | Engineer multifunctional oncolytic viruses To modulate the tumor micro-environment Proprietary Anti-cancer virus Weapons ICIs Restore T-cell/tumor interaction (Mabs/SdAbs) Depletion of Tregs TG collections + Enzymes Depletion of immuno-suppressive metabolites Ligands Activate immunologica
Slide 27: Transgene well positioned to establish leadership in the OV field
Transgene well positioned to establish leadership in the OV field Mature assets to deliver significant Novel Invir.IOTM platform clinical results in 2018 #Combination x to design next-generation virotherapies #Multifunctional Treatment Pexa-Vec: Next-generation OV, an alternative to • Only OV produc
Slide 28: 2017 Financial results
2017 Financial results Jean-Philippe DEL VP Finance
Slide 29: Key Figures | Cash and cash equivalents
Key Figures | Cash and cash equivalents €75m • €41.4 million in cash and cash €50m equivalents at year end 2017 €28.1m €13.3m • €28.1 million of cash burn €25m €56.2m €41.4m compared with €30.6 million in 2016, excluding capital increase (€13.3m of net proceeds) zero Cash at 2016 Cash BURN New Cash
Slide 30: P&L
P&L in € million 2017 2016 Var. • R&D expenses are controlled despite Revenue 8.1 10.3 (2.1) accelerating our development plan, Research and development expenses (30.4) (26.4) (4.0) starting numerous clinical trials, and a General and administrative expenses (5.7) (6.2) 0.5 planned milestone payment
Slide 31: Revenue
Revenue → €8.1 million in revenue compared with €10.3 million in 2016 In € million 2017 2016 1 Revenue from collaborative and licensing agreements 2.1 2.3 2 Government financing for research expenditures 5.4 6.4 3 Other revenue 0.6 1.6 Revenue 8.1 10.3 1 ▪ R&D Services: €0.9 million vs. €0.5 million
Slide 32: R&D expenses
R&D expenses → €30.4 million in R&D expenses compared with €26.4 million in 2016 In € million 2017 2016 D% 1 Staff costs 11.1 10.8 +3% Share-based payments 0.3 0.1 +58% 2 External IP and licensing costs 4.8 1.1 +325% External expenses on clinical projects 7.0 7.0 +1% External expenses on other proje
Slide 33: Guidance 2018
Guidance 2018 Transgene expects its cash burn for 2018 to be comparable to 2017. The Company has financial visibility until mid-2019. 33
Slide 34: Outlook
Outlook On track to deliver multiple value-enhancing clinical data readouts and preclinical milestones
Slide 35: Significant anticipated value-creating news flow
Significant anticipated value-creating news flow Clinical readout expected on 9 trials in 2018 # trials to readout in 2018 TG4010 Lung cancer (NSCLC) First Phase 2 (1st line and 2nd line) in H2 2018 2 TG4001 HPV+ head & neck cancer (SCCHN) First Phase 2 data in 2H 2018 1 TG1050 Chronic hepatitis B (
Slide 36: We would like to thank patients, clinicians and support personnel
We would like to thank patients, clinicians and support personnel for their commitment to the fight against severe diseases 36
Slide 37: Thanks for your attention
Thanks for your attention Q&A
Slide 38: Contact
Contact Lucie Larguier Director Corporate Communication and Investor Relations +33 3 88 27 91 04 / +33 6 76 24 72 27 larguier@transgene.fr / investorrelations@transgene.fr @TransgeneSA Transgene 400 Boulevard Gonthier d’Andernach - Parc d’Innovation - CS80166 67405 Illkirch Graffenstaden Cedex Franc
Slide 39: Appendices
See immunotherapeutics Appendices
Slide 40: Balance sheet
Balance sheet In € million 2017 2016 D Cash, cash equivalents and other financial assets 41.4 56.2 - 14.8 Other current assets 17.4 17.8 - 0.4 Non current assets 42.1 48.9 - 6.8 Assets 100.9 122.9 - 22.0 In € million 2017 2016 D Current liabilities 16.9 19.9 - 3.0 Non current liabilities 55.9 56.5 -
Slide 41: Cash Flow Statement
Cash Flow Statement In € million 2017 2016 D Cash used in operating activities before change in working capital (26.9) (24.4) (2.5) Change in working capital (8.5) (9.2) 0.7 Cash used in operating activities (35.4) (33.6) (1.8) Cash generated from investing activities (0.4) (2.1) 1.7 Cash generated