Valneva SE · EURONEXT:VLA
Valneva — Investor Presentation (June 2021)
28 slides from Valneva's investor presentation, Jun 7, 2021
Slide 1: Advancing Vaccines for Better Lives
Advancing Vaccines for Better Lives Company Presentation June 2021
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: Three Highly Differentiated Clinical Programs and Two Commercialized Products
Valneva Has Three Highly Differentiated Clinical Programs and Two Commercialized Products Upcoming Development Program Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Commercial Milestones Partners Further Ph 2 VLA151: Milestones in Lyme disease 2021 Clinical Portfolio Potentially VLA15532: Topline P
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 Program in Advanced Clinical Development Today 1 FDA Fast Track Designation granted Initial results reported from Phase 2 trials1, 2 2 Accelerated pediatric trial (VLA15-221) initiated in March 20213 Multivalent vaccine (six serotypes) to protec
Slide 9: VLA15: Development Outlook
VLA15: Development Outlook Phase 2 trial (VLA15-221) in adults and pediatric subjects initiated1 Trial to include participants from 5-65 years of age and a reduced immunization schedule (Month 0-6 compared to Month 0-2-6) Initial pediatric population data expected in Q2 20221 VLA15-221 will al
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; Adjuvanted with CpG 1018 1 UK government deal worth up to €1.4 billion1 with development and manufacturing funding acceleration enabled through use of Valneva’s FDA-registered facility in 2 Program UK; commercial manufacturing
Slide 13: VLA2001 Was Well Tolerated in Phase 1/2
VLA2001 Was Well Tolerated in Phase 1/2 Safety Profile Within the Expected Range for an Inactivated Vaccine Valneva Austria GmbH Page 1 of 1 ( Protocol: VLA2001-201 Figure 1.1.1 Solicited Adverse Events Within 7 Days After First Vaccination ( Safety Analysis Set (N=153) Generally well tolerated ac
Slide 14: VLA2001 Was Highly Immunogenic in Phase 1/2
VLA2001 Was Highly Immunogenic in Phase 1/2 > 90% of Trial Participants Developed Significant Levels of Antibodies Seroconversion as Measured by IgG Against S-protein (ELISA) More than 90% of all trial participants 100 developed significant levels of Proportion of Subjects with Seroconversion in T
Slide 15: VLA2001 Generated Neutralizing Antibody Titers Above Convalescent Sera Levels
VLA2001 Generated Neutralizing Antibody Titers at or Above Levels Generally Seen in Convalescent Sera in Phase 1/2 Valneva Austria GmbH Page 1 of 1 ( Valneva Austria GmbH Page 1 of 1 Valneva Protocol: ( VLA2001-201 Austria GmbH Page 1 of 1 ( Protocol: VLA2001-201 Protocol: VLA2001-201 Figure 1.2.2 F
Slide 16: Immunogenicity Summary – Cellular Response Induced
Immunogenicity Summary – Cellular Response Induced S-protein Exploratory endpoints evaluated T-cell responses by IFNgamma ELISpot analysis against S-protein, Membrane-protein and Nucleocapsid-protein. Reactive Non-reactive At Day 36, in the high dose group: 1 M-protein 76% of study participants (3
Slide 17: VLA2001: Development Outlook
VLA2001: Development Outlook Pivotal Phase 3 Trial Ongoing Pivotal Phase 3 is a randomized, observer-blind, controlled, comparative immunogenicity trial in ~ 4,000 adults, recruitment progressing well Immunological comparison against a licensed vaccine to reasonably predict efficacy (superiority o
Slide 18: Chikungunya Vaccine – VLA1553
Chikungunya Vaccine – VLA1553
Slide 19: Chikungunya is a Significant Public Health Concern
Chikungunya is a Significant Public Health Concern A Mosquito-Borne Viral Disease in Tropical/Sub-Tropical Regions Can cause debilitating joint and muscle pain, fever, headache, nausea and rash, with potential serious, long-term health impairment1 Currently there are no vaccines or effective treatme
Slide 20: VLA1553: Only Chikungunya Vaccine Candidate in Phase 3 Today
VLA1553: Only Chikungunya Vaccine Candidate in Phase 3 Today Phase 3 trial VLA1553-301 fully enrolled1; Use of surrogate marker for Ph3 endpoint 1 confirmed by FDA2; Accelerated Approval Pathway confirmed3 Potentially eligible for Priority Review Voucher4; FDA Fast Track5 and EMA PRIME6 2 designatio
Slide 21: VLA1553: Development Outlook
VLA1553: Development Outlook Pivotal Phase 3 Trial: Topline Read-out Expected Mid-2021 Phase 3 Clinical Development Program underway Pivotal Phase 3 safety and immunogenicity trial in 4,131 healthy volunteers fully recruited1 Topline data read-out on Day 29 (based on surrogate of protection) mid
Slide 22: Commercial Products
Commercial Products
Slide 23: Specialist Travel Vaccine Business and 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 24: Corporate Highlights and Newsflow
Corporate Highlights and Newsflow
Slide 25: Valneva Completed its Nasdaq Listing in May 2021
Valneva Completed its Nasdaq Listing in May 2021 End February 2021 May 2021 Number of ordinary shares: 91.7m Number of ordinary shares: 99.9m Shareholder structure1: Shareholder structure1: Groupe Groupe Grimaud Grimaud BpiFrance/ UK funds2 Groupe CDC8 UK funds2 14.9% US funds3 13.7% 18.0% 8
Slide 26: Strong Cash Position of €235.9 million at End of March 2021
Strong Cash Position of €235.9 million at End of March 2021, Plus Proceeds from US IPO Cash / cash equivalents of €235.9 million at end of March (excluding proceeds from Global Offering) The increase in liquid funds compared to December 31, 2020 results from payments made by the UK government wi
Slide 27: Key Upcoming Catalysts and Potential Inflection Points
Key Upcoming Catalysts and Potential Inflection Points Lyme disease vaccine candidate VLA15 Further Phase 2 milestones and read-outs during 2021; Phase 2 study VLA15-221, including pediatric development, initiated March 2021 COVID-19 vaccine candidate VLA2001 Phase 1/2 initial data reported, Pha
Slide 28: Thank you
Thank you Merci Danke Tack ‘WaAvalneva