Valneva SE · EURONEXT:VLA
Valneva — Investor Presentation (September 2021)
22 slides from Valneva's investor presentation, September 2021
Slide 1: Advancing Vaccines for Better Lives
Advancing Vaccines for Better Lives Company Presentation
Slide 2: Disclaimer
Disclaimer This presentation does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, Valneva SE shares to any person in the USA or in any jurisdiction to whom or in which such offer or solicitation is unlawful. Valneva is a European company. Information d
Slide 3: Valneva in Summary
Valneva in Summary We are a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need Highly specialized and targeted approach to development of unique prophylactic vaccines Advanced pipeline of
Slide 4: Research & Development
Research & Development
Slide 5: Valneva Has An Advanced Clinical Pipeline
Valneva Has An Advanced Clinical Pipeline Upcoming Development Program Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Commercial Milestones Partners VLA151: Further Ph 2 Lyme disease data in 2021 Clinical Portfolio Potentially Final clinical VLA15532: eligible for PRV data in next 6 Chikungunya mont
Slide 6: Lyme Disease Vaccine – VLA15
Lyme Disease Vaccine – VLA15
Slide 7: Lyme Disease Is a Major Health Issue
Lyme Disease Is a Major Health Issue Severe Tick-transmitted Infection, Increasingly Common in the US and Europe Early signs include flu-like symptoms1 and Erythema migrans rash2 which, if left untreated, can spread to joints (arthritis), heart (carditis) and cause neurological problems Spread of Ly
Slide 8: VLA15 – Multivalent Lyme Disease Vaccine Candidate
VLA15 – Multivalent Lyme Disease Vaccine Candidate Only Lyme Disease Program in Advanced Clinical Development Today 1 FDA Fast Track Designation granted Initial results reported from Phase 2 trials 1, 2, Recruitment completed for 2 Phase 2 trial VLA15-221 incl. pediatric participants3 Multivalent va
Slide 9: VLA15: Development Progress
VLA15: Development Progress Phase 2 trial1 in Adults and Pediatric Subjects Ongoing VLA15-221 recruitment completed in June 2021 with a total of 625 participants, 5 to 65 years of age, randomized2 The trial triggered a milestone payment of $10 million, upon dosing of the first subject, from Pfizer
Slide 10: SARS-CoV-2 (COVID-19) Vaccine – VLA2001
SARS-CoV-2 (COVID-19) Vaccine – VLA2001
Slide 11: Valneva's Response to the Global COVID-19 Crisis
Valneva’s Response to the Global COVID-19 Crisis Well-Known Inactivated Approach Based on Proven Technology Intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination, i
Slide 12: VLA2001 – The Only Inactivated Vaccine in Clinical Development in Europe
VLA2001 – The Only Inactivated Vaccine in Clinical Development in Europe Program acceleration enabled through use of Valneva’s FDA-registered facility in 1 Scotland, where commercial manufacturing commenced January 20211 Valneva’s proven approach of inactivated vaccines with Dynavax’s 2 Combines adv
Slide 13: VLA2001: Development Outlook
VLA2001: Development Outlook Rolling Submission to MHRA has Commenced1 “Cov-Compare” (VLA2001-301) is a randomized, observer-blind, controlled, comparative immunogenicity trial in over 4,000 adults (fully enrolled2) Immunological comparison against a licensed vaccine to reasonably predict efficacy
Slide 14: Chikungunya Vaccine – VLA1553
Chikungunya Vaccine – VLA1553
Slide 15: VLA1553: Only Chikungunya Vaccine Candidate in Phase 3 Today
VLA1553: Only Chikungunya Vaccine Candidate in Phase 3 Today Positive Topline Results for Phase 3 trial VLA1553-301 reported1; Use of surrogate marker for 1 Phase 3 endpoint confirmed by FDA2; Accelerated Approval Pathway confirmed3 Potentially eligible for Priority Review Voucher4; FDA Fast Track5
Slide 16: VLA1553: Development Outlook
VLA1553: Development Outlook Pivotal Phase 3 Trial – Final Data Expected Within the Next 6 Months Most advanced chikungunya vaccine development program in the world Pivotal Phase 3 safety and immunogenicity trial progressing towards final analysis, expected within the next six months1 Lot-to-Lot
Slide 17: Commercial Products
Commercial Products
Slide 18: Valneva Has a Specialist Travel Vaccine Business and is a Contractor to the US Military
Valneva Has a Specialist Travel Vaccine Business and is a Contractor to the US Military Prior to the pandemic, Valneva demonstrated a strong track record of sales growth built upon the solid foundation of its business relationship with the US DoD — €129.5m of product sales in 2019 (+25% AER, +22%
Slide 19: Corporate Highlights and Newsflow
Corporate Highlights and Newsflow
Slide 20: Strong Cash Position of €329.8 million at End of June
Strong Cash Position of €329.8 million at End of June including Proceeds from US IPO Cash / cash equivalents of €329.8 million at end of June (including proceeds from Global Offering) Successful Nasdaq listing (Q2); $107.6 million of gross proceeds Raised in an initial US public offering and a
Slide 21: Key Upcoming Catalysts and Potential Inflection Points
Key Upcoming Catalysts and Potential Inflection Points Chikungunya vaccine candidate VLA1553 Final Phase 3 trial results expected within the next six months Topline data of clinical lot-to-lot consistency Phase 3 trial expected late 2021 Lyme disease vaccine candidate VLA15 Further Phase 2 mil
Slide 22: Thank you
Thank you Merci Danke Tack ‘WaAvalneva