Valneva SE · EURONEXT:VLA
Valneva — Investor Presentation (January 2022)
29 slides from Valneva's investor presentation, January 2022
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 and Two Approved Products
Valneva Has An Advanced Clinical Pipeline and Two Approved Products Upcoming Development Program Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Commercial Milestones Partners Further Ph 2 VLA151: data in H1 2022; Lyme disease Ph3 trial initiation expected in 2022 Clinical Portfolio VLA15532: Potenti
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 2 Exclusive, worldwide partnership with Pfizer Topline results reported from Phase 2 trials1, 2, incl. booster response3; 3 Recruitment completed f
Slide 9: VLA15: Development Progress and Outlook
VLA15: Development Progress and Outlook Phase 2 trial1 in Adults and Pediatric Subjects Ongoing VLA15-221 recruitment completed in June 2021 with a total of 625 randomized participants, 5 to 65 years of age2 Topline results for VLA15-221 are expected in the first half of 2022 VLA15-221 will also
Slide 10: SARS-CoV-2 (COVID-19) Vaccine – VLA2001
SARS-CoV-2 (COVID-19) Vaccine – VLA2001
Slide 11: VLA2001 – The Only Inactivated Vaccine Against COVID-19 in Clinical Development in Europe
VLA2001 – The Only Inactivated Vaccine Against COVID-19 in Clinical Development in Europe Builds on Valneva’s IXIARO® manufacturing technology combined with Dynavax’s CpG 1 1018 adjuvant1 2 EMA rolling review and UK MHRA, Bahraini NHRA rolling submissions ongoing 3 Advance purchase agreements for up
Slide 12: Cov-Compare: Head-to-Head vs. AstraZeneca's Approved COVID-19 Vaccine AZD1222
Cov-Compare: Head-to-Head vs. AstraZeneca’s Approved COVID-19 Vaccine AZD1222 Study design and endpoints planned to support regulatory submissions 995 Study Description 1,977 Randomized, observer-blind, controlled, immunogenicity trial comparing VLA2001 to AstraZeneca’s conditionally approved vacc
Slide 13: VLA2001: Statistically More Favorable Tolerability Profile Compared to AZD1222
VLA2001: Statistically More Favorable Tolerability Profile Compared to AZD1222 Generally well tolerated across all tested age groups Solicited AEs within 7 days of vaccination Safety Conclusions • Tolerability profile more favorable vs comparator vaccine in participants aged 30 years and above • Wel
Slide 14: Co-Primary Immunogenicity Endpoints Met
Co-Primary Immunogenicity Endpoints Met Superiority in neutralizing antibody levels (GMT ratio) & non-inferiority in seroconversion rate SARS-CoV-2 Neutralizing Antibody Levels Seroconversion Rate 120 900 (ND50) – IMM population (IgG Against S-protein (ELISA) (Geometric Mean Titer, 95% CI) Neutraliz
Slide 15: Overall Cov-Compare Study Conclusions
Overall “Cov-Compare Study” Conclusions Immunogenicity Safety and Tolerability • VLA2001 met its co-primary endpoints vs • VLA2001 was generally well tolerated: AZD1222, demonstrating: o Significantly more favorable profile compared to o Superiority in terms of geometric mean titer for AZD1222 neutr
Slide 16: Positive Topline Homologous Booster Data
Positive Topline Homologous Booster Data 77 participants, aged 18-55 years, received a third dose (booster dose) seven to eight months after completion of their primary immunization. Excellent immune response after a booster dose of VLA2001 (GMT 9699.3 (95% CI: 8497.76, 11070.71)) Antibody titer
Slide 17: Current Purchase Agreements and Advanced Discussions
Current Purchase Agreements and Advanced Discussions European Commission: Up to 60 million doses of VLA2001 to be supplied in 2022-231 24.3 million doses to be supplied in the second and third quarters of 2022; EC has the option to increase its initial purchase, the remainder of which would be del
Slide 18: VLA2001: Potential to Protect Against Variants
VLA2001: Potential to Protect Against Variants Valneva believes VLA2001 can potentially play a role in protecting against the new Omicron variant1 VLA2001 is developed using the entire SARS-CoV-2 virus envelope (rather than targeting the spike protein alone) › Preserving the whole virus envelope i
Slide 19: VLA2001: Value Growth Through Continuous Extension of Label
VLA2001: Value Growth Through Continuous Extension of Label Primary Immunization 2-11 yrs. Primary Immunization 12-17 yrs. Strategic value development Target Product Profile Booster incl. mix/match Primary Immunization 55 yrs.+ Potential switch to variant if required (VLA2101) Primary Immunization 1
Slide 20: Chikungunya Vaccine – VLA1553
Chikungunya Vaccine – VLA1553
Slide 21: VLA1553: The Most Advanced Chikungunya Vaccine Candidate
VLA1553: The Most Advanced Chikungunya Vaccine Candidate Positive topline Phase 3 data (VLA1553-301)1 and lot-to-lot consistency results (VLA1553-302)2 1 reported 2 Potentially eligible for Priority Review Voucher3; FDA Breakthrough Therapy4, Fast Track5 and EMA PRIME6 designations granted; FDA subm
Slide 22: VLA1553-301: Positive Topline Phase 3 Results
VLA1553-301: Positive Topline Phase 3 Results Immunogenicity • VLA1553 met its primary endpoint: o Protective CHIKV neutralizing antibody titers reported in 98.5% of subjects after a single shot o Highly immunogenic across all age groups, including the elderly Safety and Tolerability • VLA1553 was w
Slide 23: VLA1553: Development Outlook
VLA1553: Development Outlook Pivotal Phase 3 Trial – Final Data Expected in Q1 2022 Most advanced chikungunya vaccine development program in the world Pivotal Phase 3 safety and immunogenicity trial progressing towards final analysis, in Q1 20221 Positive topline lot-to-lot consistency trial res
Slide 24: Commercial Products
Commercial Products
Slide 25: 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 26: Corporate Highlights and Newsflow
Corporate Highlights and Newsflow
Slide 27: VLA Successfully Raised ~ $210 Million in 2021
VLA Successfully Raised ~ $210 Million in 2021 Successful Nasdaq listing (Q2); $107.6 million of gross proceeds Raised in initial US public offering and private placement in Europe Successful follow-on (Q4); $102.0 million of gross proceeds Raised in a global offering in the US and Europe Va
Slide 28: Key Upcoming Catalysts and Newsflow
Key Upcoming Catalysts and Newsflow Chikungunya vaccine candidate VLA1553 Final Phase 3 trial results expected in Q1 2022 (including lot-to-lot consistency trial) Initiation of regulatory submissions with FDA and EMA Lyme disease vaccine candidate VLA15 Remaining Phase 2 results and alignment
Slide 29: Thank you
Thank you Merci Danke Tack ‘WaAvalneva