Valneva IPO Presentation Deck

Made public by

sourced by PitchSend

2 of 44

Creator

Valneva logo
Valneva

Category

Healthcare

Published

April 2021

Slides

Transcriptions

#1Vvalneva Advancing Vaccines for Better Lives Roadshow Presentation April 2021 s и#2V Valneva has filed a registration statement, which includes a preliminary prospectus, with the Securities and Exchange Commission ("SEC") for the offering to which this presentation relates. Before you invest, you should read the preliminary prospectus in that registration statement and other documents Valneva has filed with the SEC for more complete information about the Company and this offering. You may obtain these documents for free by visiting EDGAR on the SEC website at www.sec gov. Alternatively, Valneva, any underwriter or any dealer participating in the offering will arrange to send you the prospectus if you request it by contacting the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone 1-866-471-2526, or by emailing [email protected]; Street, 2nd Floor, New York, New York 10014; or Jefferies LLC Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by emailing Prospectus [email protected] Valneva is a European company. Information distributed is subject to European disclosure requirements that are different from those of the United States. Financial statements and information may be prepared according to accounting standards which may not be comparable to those used generally by companies in the United States. This presentation includes only summary information and does not purport to be comprehensive. Any information in this presentation is purely indicative and subject to modification at any time. Valneva does not warrant the completeness, accuracy or correctness of the information or opinions contained in this presentation. None of Valneva, or any of their affiliates, directors, officers, advisors and employees shall bear any liability for any loss arising from any use of this presentation. Certain information and statements included in this presentation are not historical facts but are forward-looking statements. The forward-looking statements (a) are based on current beliefs, expectations and assumptions, including, without limitation, assumptions regarding present and future business strategies and the environment in which Valneva operates, and involve known and unknown risk, uncertainties and other factors, which may cause actual results, performance or achievements to be materially different from those expressed or implied by these forward-looking statements, (b) speak only as of the date this presentation is released, and (c) are for illustrative purposes only. Investors are cautioned that forward-looking information and statements are not guarantees of future performances and are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Valneva. Disclaimer Valneva - Roadshow Presentation April 2021 2#3Offering Summary Issuer Ticker / Exchange Base Offering Size Options to Purchase Additional Shares ADS ordinary share ratio Price Range Use of Proceeds Cash Position Bookrunners Expected Pricing Lock-up Valneva - Roadshow Presentation Valneva SE Nasdaq Global Market / VALN 7,082,762 shares/3,541,381 ADSS (-$100 million gross proceeds, based on closing price 27/04/2021, 100% primary) 1,062,414 shares/531,207 ADSS (100% primary, 15% of base deal) 2:1 Final offering price will be at least equal to the VWAP of shares on Euronext between 3-5 trading days preceding pricing date with a maximum discount of 15% Valneva intends to use the net proceeds we receive from this offering, together with its existing cash and cash equivalents, as follows: ■ Approximately $100 million to fund further development of our Lyme VLA15 vaccine candidate through completion of Phase 2 clinical trials; ■ Approximately $120 million to fund further development of our chikungunya VLA1553 vaccine candidate through BLA approval; Approximately $80 million to fund further development of our COVID-19 VLA2001 vaccine candidate through conditional licensure; and ■ Any remaining amounts to fund working capital and general corporate purposes. As of December 31, 2020, Valneva had cash and cash equivalents of €204.4 million Goldman Sachs, Jefferies, Guggenheim, Bryan Garnier May 5th, 2021 90 day lock-up for the Company, Management Board, Supervisory Board, and certain of their shareholders, 30 day lockup with respect to one of the company's 5% + shareholders April 2021#4Valneva's Management Team Thomas Lingelbach President & Chief Executive Officer CEO of Intercell, Managing Director for Novartis Vaccines & Diagnostics Germany, VP Global Industrial Operations at Chiron Vaccines; 30 years in the vaccine industry. intercell SMART VACCINES CHIRON U NOVARTIS VACCINES Valneva - Roadshow Presentation Franck Grimaud President & Chief Business Officer CEO of Vivalis, formerly responsible for Groupe Grimaud's development in Asia; 25 years in corporate business development and life sciences. GROUPE GRIMAUD Prendre soin de la vie Vivalis Frédéric Jacotot General Counsel & Corporate Secretary VP Legal & IP and General Counsel of Valneva, former Division Counsel at Abbott; 30 years in the pharmaceutical industry. Abbott Juan Carlos Jaramillo, MD Chief Medical Officer Senior international positions including GSK, Celsion, Grünenthal and Daiichi Sankyo; 20 years in life sciences. gsk Celsion Corporation GRÜNENTHAL Daiichi-Sankyo David Lawrence Acting Chief Financial Officer V CFO of Acambis plc, VP Finance at Chiron Vaccines, GSK, non- executive and strategic advisory experience; 30 years in vaccines and life sciences. gsk CHIRON Acambis The sure of vaccines. Toder April 2021 4#5Valneva 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 V ■ Highly specialized and targeted approach to development of unique prophylactic vaccines ■ Advanced pipeline of differentiated clinical-stage assets designed to address large target populations ■ Product development and regulatory expertise with clear demonstrated ability of rapidly moving new vaccines through the clinic to commercialization Highly developed, nimble and sophisticated manufacturing infrastructure ■ Two commercialized vaccines, a specialist sales infrastructure and distribution rights for third-party vaccines, which help to fund our clinical development efforts Highly experienced leadership team with expertise in the vaccine space Valneva - Roadshow Presentation April 2021 5#6Valneva Has Three Highly Differentiated Clinical Programs And Two Commercialised Products Clinical Portfolio Commercial Portfolio Program VLA15¹: Lyme disease VLA1553²: Chikungunya VLA2001: COVID-19 IXIARO: Japanese Encephalitis DUKORAL: Cholera, ETEC³ Discovery Pre-Clinical Phase 1 Valneva - Roadshow Presentation Phase 2 Phase 3 Commercial Potentially Eligible for PRV Upcoming Milestones Further Ph 2 Milestones in 2021 Topline Ph 3 Data mid-2021 Ph 3 data Q3/2021 M Development Partners Pfizer UK Vaccines Task Force VLA15 received Fast Track designation from the FDA. ² VLA1553 received Fast Track designation from the FDA, PRIME designation from the European Medicines Agency and is also potentially eligible for a U.S. Priority Review Voucher. Indications differ by country - Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which this vaccine is licensed, ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium Note: We are developing VLA1601, a highly purified inactivated vaccine candidate for Zika Virus and VLA84, a vaccine candidate against Clostridium difficile. Both of these programs are currently on hold. April 2021#7Valneva's Global Network ~650 staff mainly in R&D/Operations in Austria, UK, Sweden LIVINGSTON, UK - Manufacturing -Commercial Operations (London) NANTES, FRANCE - Registered office -Vaccine discovery research LYON. FRANCE - Commercial Operations Valneva - Roadshow Presentation SOLNA, SWEDEN - Manufacturing - Commercial Operations Nordics (SE. DK, NO, FI) VIENNA, AUSTRIA - Vaccines pre-clinical and clinical R&D - Manufacturing (Quality Assurance/ Control) - Commercial Operations MONTREAL CANADA Commercial Operations GAITHERSBURG. USA Commercial Operations April 2021 7#8Lyme Disease Vaccine - VLA15 N#9Lyme 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 No available treatment to protect against Lyme disease Global market estimated to reach $1 billion by 2030 Direct medical costs in the U.S. estimated up to $1.3 billion - indicating an attractive health economic benefit³ 2001 Valneva - Roadshow Presentation Spread of Lyme Across the US4 'Fever, chills, headache, fatigue, muscle and joint aches, swollen lymph nodes. 2 Occurs in approx. 70-80% of infected persons, Adrion, E. et al PLOS ONE Feb 2015. *Centers for Disease Control and Prevention April 2021#10VLA15 - Multivalent Lyme Disease Vaccine Candidate Only Program in Advanced Clinical Development Today 1 FDA Fast Track Designation granted 5 2 4 3 Initial results reported from Phase 2 trials ¹, 2 Accelerated pediatric trial (VLA15-221) initiated in March 2021³ Multivalent vaccine (six serotypes) to protect against Lyme disease in the United States and Europe Follows proven Mechanism of Action for a Lyme disease vaccine Exclusive, worldwide partnership with Pfizer Vaineva announces positive initial results for Phase 2 study of Lyme Disease vaccine candidate. 2 Vaineva announces positive initial results for second Phase 2 study of Lyme Disease vaccine candidate VLA15,³ Valneva announces acceleration of pediatric development for Lyme Disease vaccine candidate. Valneva - Roadshow Presentation April 2021 10#11Mechanism of Action of OspA Based Vaccines Is Understood Anti-OspA Protective Response with Lyme Disease Vaccines Step 1 Vaccine, when injected, elicits high levels of anti- OspA antibodies Ha Valneva - Roadshow Presentation Step 2 Tick attaches to vaccinated human and begins blood meal (24- to 48-hour attachment needed to transmit B. burgdorferi) Step 3 Anti-OspA antibodies from human host enter tick Step 4 Human anti-OspA antibodies eliminate B. burgdorferi in tick midgut, preventing transmission to human host April 2021 11#12Phase 1 + Booster Confirmed Substantial Anamnestic Response GMT for Highest Adjuvanted Dose Group in Phase 1 (VLA15-101) IgG GMT of Highest Adjuvanted Group (90µg + Alum) Before and After Primary Series and Booster Dose IgG GMT by Serotype over Time EU 1000 100 10 Post Primary Post Booster N (Day 0-365) = 28 N (Month 14)= 16 ST1 Valneva - Roadshow Presentation ST2 ST3 Serotype ST4 Day 0 Day 84 STS Day 365 ST6 Month 14 April 2021 12#13Phase 2 Month 0-2-6 Schedule Showed High Immunogenicity V SCRS (Seroconversion Rates) after Completion of Primary Vaccination Series Ranged From 93.8% to 98.8% in Highest Dose Seroconversion Rate (%) with 95% Confidence Intervals Seroconversion Rates for OspA-specific IgG by ELISA, per Serotype, D208, PP Population 100 80 60 40 20 0 LLLLLL ST1 I ST2 Treatment Group = 135 µg ST3 Valneva - Roadshow Presentation ST4 ST5 ☐ 180 µg No statistically significant differences observed between 135µg and 180µg treatment groups ■ Placebo ST6 April 2021 13#14VLA15: 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) The trial triggered a milestone payment of $10 million, upon dosing of the first subject, from Pfizer to Valneva Initial pediatric population data expected in Q2 2022¹ VLA15-221 will also investigate a booster dose of VLA15, administered one year following the six Month dose¹ V ■ Phase 3 pivotal efficacy trial planned to commence pending positive readout from VA15-221 in 2022¹ Clinical readout, based on one tick season, projected end 2023 ■ Subject to regulatory approval first licensure anticipated H1 2025 1Valneva and Pfizer Announce Initiation of Phase 2 Study for Lyme Disease Vaccine Candidate Valneva - Roadshow Presentation April 2021 14#15VLA15: Exclusive, Worldwide Partnering Deal with Pfizer Collaboration with Pfizer for Late Stage Development and Future Commercialization Pfizer funding 70% of development costs through program completion Valneva eligible to receive a total of $308 million upfront and milestone payments ($140 million received to date) Valneva to receive tiered royalties starting at 19% Valneva - Roadshow Presentation V 2Pfizer April 2021 15#16Chikungunya Vaccine - VLA1553 M#17Chikungunya is a Significant, Growing Public Health Concern V A Mosquito-Borne Viral Outbreak 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 treatments for chikungunya Global market, including endemic regions (see below), estimated to exceed $500 million annually by 2032² 2020 outbreaks³: The Americas (incl. Brazil, the Caribbean, Colombia, Costa Rica, Mexico), Asia (India, Malaysia, Thailand) and Africa (Congo, Kenya, Sudan) 'Valneva Chikungunya Factsheet. 2 VacZine Analytics Chikungunya virus vaccines Global demand analysis. February 2020. ECDC chikungunya worldwide overview. Valneva - Roadshow Presentation April 2021 17#18VLA1553 - Only Chikungunya Vaccine Candidate in Phase 3 Today 1 Phase 3 trial VLA1553-301 fully enrolled¹; Use of surrogate marker for Ph3 endpoint confirmed by FDA2; Accelerated Approval Pathway confirmed³ 2 3 Potentially eligible for Priority Review Voucher4; FDA Fast Track5 and EMA PRIME designation granted Single shot, live attenuated prophylactic vaccine targeting chikungunya virus neutralization 4 Up to $23.4 million awarded to Valneva for R&D by CEPI; Partnership with Instituto Butantan for LMICS8 Valneva - Roadshow Presentation 5 Excellent fit with existing commercial and manufacturing capabilities Note: Photo credit: James Gathany. 1 Valneva Completes Recruitment for Pivotal Phase 3 Trial of Chikungunya Vaccine Candidate and Initiates Antibody Persistence Trial 2 Valneva Announces Publication of 2020 Universal Registration Document and Provides Business Updates 3 Valneva reports positive End-of-Phase 2 Chikungunya meeting with the U.S. FDA and sets stage for Phase 3 Study; 4 https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority-review-voucher-program. 5 Valneva awarded FDA Fast Track Designation for Chikungunya vaccine candidate. 6 Valneva's Chikungunya vaccine candidate awarded EMA prime designation. 7 CHIKV LR2006-OPY1 infectious clone was attenuated by deleting large part of gene coding nsP3 (alphavirus-replicase). 8 Valneva to partner with Instituto Butantan on single-shot Chikungunya vaccine for low- and middle- Income countries. April 2021 18#19Phase 1 Trial Led to Direct Progression into Phase 3 ■ Observer-blinded, randomized, multicenter, dose escalation study ■ Study Population: 120 healthy volunteers aged 18 to 45 years 50 ■ Dosage: 3.2x10³ TCID 50 (0.1ml), 3.2x104 TCID (1ml), 3.2x105 TCID50 (1ml) ■ Immunization route: intramuscular SCREENING PART A Sample Size N = 120 Day/M -21 Study Arm L R Study Arm M H Study Arm H **** 0 28/M1 Valneva - Roadshow Presentation Dose: 3.2x10³/0.1mL PART B Dose: 3.2x104/1mL Dose: 3.2x105 / 1mL 84/M3 Safety including viremia on Days 0/3/7/14 post-vaccination N=30 N=30 N=60 R RYT Study Arm H1 Study Arm H2 180/M6 M7 ***** PART C N=30 N=30 M12 D COD- **** V M13 Re-vaccination at Month 6 and 12 with the highest dose (homologous viral challenge) April 2021 19#20Phase 1 of VLA1553 Showed Enduring High Immunogenicity V A Single Shot is Sufficient to Induce High-Titre Neutralizing Antibodies Sustained at Twelve Months Post Vaccination 1000 GMT (G5% CI) 100 10 1 Day 0 Study Arm *ANOVA Arm L vs. M p = 0.0348 Arm L vs. Hp = 0.0020 Valneva - Roadshow Presentation Day 3 Arm L Day 7 Day 14 Arm M Day 28 Arm H Day 84 Day 180 Arm H1 Month 12 April 2021 20#21High Dose Vaccination Protects Against Challenge-Induced AES V VLA1553-101: High Dose After Single/Re-Vaccination Reactogenicity of High Dose After Single Vaccination Joint pain Muscle pain Fatigue Rash Headache -Mild (Grade 1) High Dose: 3.2*105 TCID 50 30% Swelling 20% 10% 0% Vomiting Valneva - Roadshow Presentation Redness Nausea -Moderate (Grade 2) Induration Fever Pain Tenderness -Severe (Grade 3) B Reactogenicity of High Dose After Re-Vaccination (M6): Protection from AEs Joint pain, Muscle pain Fatigue Rash Headache -Mild (Grade 1) Swelling 30% 20% 10% Vomiting Redness Nausea -Moderate (Grade 2) Induration Fever Pain Tenderness -Severe (Grade 3) April 2021 21#22VLA1553: Clinical Data in Phase 1 in 120 Subjects Clinical Trial VLA1553-101 Published in Lancet ID¹ Immunogenicity 100% Seroconversion Rate achieved at Day 14 after a single vaccination in all dose groups; fully sustained at 100% by Month 12 A single vaccination of VLA1553 was sufficient to induce sustaining, high-titer, neutralizing antibodies at all dose levels one year after priming ■Upon Re-Vaccination ("Challenge"): No anamnestic response No vaccine-strain viremia Highly immunogenic after single vaccination 1 Wressnigg et al. 2020; Lancet Infect Dis 20:1193-1203. Valneva - Roadshow Presentation V Safety No safety concerns identified, well- tolerated in the low and medium doses Excellent local tolerability ■ Systemic adverse events included short- term fever, headache and fatigue, muscle pain No vaccine related Serious Adverse Events or Adverse Events of Special Interest Safety profile supported Phase 3 progression with medium dose April 2021 22#23VLA1553: 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 enrolled¹ - - - Topline read-out on Day 29 (based on surrogate of protection) mid-2021 Lot-to-Lot consistency trial initiated (VLA1553-302) in ~400 volunteers² Antibody persistence follow-up trial initiated (VLA1553-303) - up to 375 volunteers from VLA1553-301 will be followed up annually for five years after a single immunization¹ Adolescents' clinical trial in 750 volunteers in Brazil planned to commence in 2021³ Accelerated approval pathway agreed with FDA4 ■ VLA1553 may be eligible for Priority Review Voucher upon FDA approval5 ¹ Vaineva Completes Recruitment for Pivotal Phase 3 Trial of Chikungunya Vaccine Candidate and Initiates Antibody Persistence Trial 2 Valneva Initiates Phase 3 Clinical Lot Consistency Study for its Single-Shot Chikungunya Vaccine Candidate. In collaboration with development partner Instituto Butantan, under CEPI funding. Valneva Announces Publication of 2020 Universal Registration Document and Provides Business Updates https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority- review-voucher-program Valneva - Roadshow Presentation April 2021 23#24SARS-CoV-2 (COVID-19) Vaccine - VLA2001#25VLA2001's Inactivated Virus Technology Allows for Potential Differentiation H 81 VLA2001 - an inactivated, adjuvanted COVID- 19 vaccine candidate... ■ Only COVID-19 vaccine candidate in clinical trials in Europe using inactivated virus technology, an approach that is well established ■ Potential to be used as booster vaccine in all age groups ■ Potential ease of storage and distribution (expected 2 to 8°C) ■ Potential platform for new variants ...with a clear go to market strategy V ■ 100M doses contract signed with UK government for 2021-2022 Discussions with other potential customers ongoing ■ Initiated process with potential US partners to evaluate entering the US market ■ Manufacturing track record and FDA/EMA/MHRA approved facilities#26VLA2001 - The Only Inactivated Vaccine in Clinical Development in Europe: Adjuvanted with CpG1018 1 UK government deal worth up to €1.4 billion¹ with development and manufacturing funding; ongoing dialogue with other potential customers 5 2 Program acceleration enabled through use of Valneva's FDA-registered facility in UK; commercial manufacturing commenced January 2021³ Valneva - Roadshow Presentation 3 Combines Valneva's proven approach of inactivated vaccines with Dynavax's advanced CpG 1018 adjuvant Phase 1/2 clinical trial results reported5, Phase 3 initiated Regulatory submission to MHRA planned in autumn 2021, deliveries thereafter, subject to approval Note: Photo credit: CDC/Alissa Eckert, MSMI; Dan Higgins, MAM. Valneva announces major COVID-19 vaccine partnership with U.K. Government. Vaineva in advanced discussion with European Commission to supply up to 60m doses of Inactivated, Adjuvanted COVID-19 vaccine candidate. ³ Valneva commences manufacturing of its Inactivated, Adjuvanted COVID-19 vaccine, completes Phase 1/2 study recruitment. Valneva and Dynavax announce commercial supply agreement for Inactivated, Adjuvanted COVID-19 vaccine. "Vaineva Reports Positive Phase 1/2 Data for Its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001 April 2021 26#27VLA2001 Was Well Tolerated in Phase 1/2 Safety Profile Within the Expected Range for an Inactivated Vaccine First vaccination Second vaccination (5) aug Subjects with Sold Byro (5) 201- 10- DOW GROULOS aching Lab Tenderness Valneva - Roadshow Presentation Terem EVENTS Low Deere Neu Falque JM Fatge EVENTS | Low Doseondt) ■ Vestum Dosef49) © High Dưeep-501 Safety Analysis Set, Figure 1.1.1 and 1.1.2, Table 14.2.1.2 and 14.2.1.3 M Generally well tolerated across all dose groups tested, no safety concerns identified by an independent Data Safety Monitoring Board. No statistically significant differences between dose groups and no differences between first and second vaccinations in terms of reactogenicity. Majority of Adverse Events (AES) were mild or moderate and only two subjects reported severe solicited AEs (headache and fatigue). ■All solicited AEs transient. ■ Only 17.6% of unsolicited AEs up to day 36 were considered related to the vaccine and no severe unsolicited AEs were reported. No serious related AEs. April 2021 27#28VLA2001 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) Proportion of Subjects with Seroconversion in Terms of S-protein specific IgG Antibodies (%) with 95% CI 100 90 80 70 60 40 30 20 10 0 Day 22 Low Dose Medium Dose High Dose Overall Per-Protocol Analysis Set, Table 14.3.5.1, Table 14.3.6.1 Valneva - Roadshow Presentation Day 36 ■ More than 90% of all trial participants developed significant levels of antibodies to the SARS-CoV-2 virus spike protein across all dose groups tested. ■ Seroconversion Rates (SCR) for S- protein binding IgG antibodies were 89.8% in the medium dose and 100% in the high dose group. Two weeks after completion of the two dose schedule, Geometric Mean Fold Rises (GMFRS) from baseline were 26 in the medium dose and 86 in the high dose group. April 2021 28#29VLA2001 Generated Neutralizing Antibody Titers at or Above Levels Generally Seen in Convalescent Sera in Phase 1/2 Neutralizing Antibody Titres (MNA50) 10000 2000 1500 1000 200 10 Figure 1.2.1 Plot of SARS-CoV-2 Neutralizing Antibodies (ND50) Over Time by Dose Groups Per-Protocol Analysis Set (N=150) Day B Day 1 Low Medium High Low High Dose groups Day 1: Low-51) Medium(n-49) High(n-50) Day Lowin=51) Medium(n=49) High-50); ( Day 22: Low(n-50) Medium(-48) High-48) Day38 Lown-51) Medium(-48) High-50% ( Note: Graph shows GMT and 95% Cl. Green scatter dots are the actual distribution of neutralizing antibody tes Data Source: ADS, Table 14.3.1.1 Program Location: E-Projects/1222Malnoval Stats\Programs F_1_2_1.a Day 22 P(0.000 Medium Day 36 P-value: 0.001 Valneva - Roadshow Presentation Low Low Medium High Medium High ( Dato: 01APR2021:00:49 Figure 1.2.2 Plot of SARS-CON-2 Neutralizing Antibodies (N050) for Convalescent Sera All Convalescent Subjects (N=32) Convalescent Sea Graph shows GMT and 95% CI Green scatter dots are the actual distribution of neutralizing antibody titres. Source ADIS, Table 14.5.1.1 M SARS-CoV-2 Neutralizing Antibodies (MNA50) ■ Dose dependent response, statistically significant higher Geometric Mean Titers (GMTs) in high dose group compared to low and medium dose groups. In high dose group, GMT of neutralizing antibody titers of 530.4 (95% CI: 421.49, 667.52). With a GMT ratio of vaccine vs. convalescent sera 21 vaccine efficacy has been reported above 80% for other vaccines. Per-Protocol Analysis Set, Figure 1.2.1; Convalescent Subjects, Figure 1.2.2 Earle et al. MedRxiv, March 2021, https://doi.org/10.1101/2021.03.17.20200246); Khoury et al. MedRxiv, March 2021, https://doi.org/10.1101/2021.03.09.21252641 April 2021 29#30IgG Antibody Response Was Highly Correlated With Neutralization Titers IgG antibody titers (ELISA) [ELU/mL] Scatter Plot between Neutralizing Antibody Titres ND50 (MNA) and IgG Antibody Titres (ELISA) Per-Protocol Analysis Set 10000 1000 100 - (N=150) Valneva - Roadshow Presentation 250 500 Neutralizing antibody titers (MNA50) 0.79 r= P-value <0.001 750 1000 1500 2000 Visit . Day 1 ● Day 8 • Day 22 • Day 36 Note: Scatter plot shows correlation between results of ELISA (ELU/mL) and MNA (ND50). Pearson correlation coefficient (r) between ELISA (ELU/mL) and MNA(ND50) and P-value for testing the significance of correlation coefficient is also presented in the plot. Red dotted lines present the limit of detection for ELISA (50.3 ELU/mL) and MNA (ND50=58). Per-Protocol Analysis Set, Figure 1.5 V ■ Neutralization Titers (MNA50) vs. S-protein Specific IgG (r=0.79, p<0.001) April 2021 30#31Immunogenicity Summary - Cellular Response Induced Exploratory endpoints evaluated T-cell responses by IFNgamma ELISpot analysis against S-protein, Membrane-protein and Nucleocapsid-protein. At Day 36, in the high dose group: ■76% of study participants (34/45) were reactive 1 against peptide pools spanning the full-length S- protein 36% (16/45) against the M-protein 49% (22/45) against the N-protein S-protein ■ Reactive Non-reactive M-protein Reactive Non-reactive N-protein V Reactive Non-reactive ¹Sample is considered reactive against individual stimulation panel (peptide pools) if normalized spot counts (Nil control counts substracted) per 2.10 x 10^5 PBMCs 26 Valneva - Roadshow Presentation April 2021 31#32VLA2001: Development Outlook Pivotal Phase 3 Trial Initiated ■ Pivotal Phase 3 is a randomized, observer-blind, controlled, comparative immunogenicity trial in ~ 4,000 adults Immunogical comparison against a licensed vaccine to reasonably predict efficacy (superiority of VLA2001 in a two-dose immunization schedule four weeks apart - GMTs of neutralising antibodies, at two weeks after the second vaccination) Study conducted in UK supported by DHSC/NIHR, including funding Protocol agreed with MHRA; discussion with other regulatory bodies ongoing ■ Additional studies planned Booster studies (including reduced booster dose) Valneva - Roadshow Presentation April 2021 32#33VLA2001: Collaboration to Provide up to 190 Million Doses of M Inactivated, Adjuvanted Vaccine to the UK ■ UK Government Agreement worth up to €1.4 Billion with Valneva to supply up to 190 million doses¹ Including 100 million doses for 2021/2022 - UK Government retains options over a further 90 million doses for supply between 2023 and 2025² ■ Agreement includes funding support for expansion of Valneva's manufacturing facilities³ and clinical development in the UK ■ Ongoing dialogue with UK VTF regarding variant based vaccines 1 Valneva announces major COVID-19 vaccine partnership with U.K. government. 2 Valneva announces UK Government exercise of option for 40m doses of its Inactivated, Adjuvanted COVID-19 vaccine, ³ Vaineva confirms participation in UK Government COVID-19 vaccine response program. Valneva - Roadshow Presentation April 2021#34Commercial Products 1#35Valneva 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% CER) ¹ Direct sales channels in the US, Canada, UK, France, Nordics, and Austria ■ Distributors in Germany, Australia/NZ and smaller markets Marketing & Distribution of 3rd party specialty vaccines² Three year supply deal with US Military/Dept of Defense representing a base value of $135m if options are exercised Valneva believes that the commercial business is a key asset for the future, e.g. chikungunya route to market, once the travel industry recovers Valneva reports record product sales and major pipeline progress in 2019. Valneva and Bavarian Nordic Announce Marketing and Distribution Partnership Valneva - Roadshow Presentation April 2021 35#36Financial Summary FY 2020 www#37Company in Strong Position to Scale its Business Valneva Has a Strong Cash Position UK Government COVID-19 collaboration including instalments to mitigate capex and working capital related to clinical trials and inventory build-up Finished up 2020 with €204 million in cash Access to largest life science capital market / cash-equivalents ■ Provides capital to accelerate R&D programs Supplements capital received from UK COVID-19 deal Commercial business supported by US Military contract revenues V ¹Market Data 20-04-2021 US IPO Is Part of Capital Formation Strategy Valneva - Roadshow Presentation - Opportunity to build R&D pipeline as current programs advance Valneva (VLA): Approximately 93m Shares in Issue, and a Market Cap of Approximately €1,200m¹ Enables potential opportunistic plays to acquire other vaccine assets April 2021 37#382021 Catalysts N 1#39Key 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; Chikungunya vaccine candidate VLA1553 ■ Initial Phase 3 data expected mid-2021; Phase 3 now fully recruited COVID vaccine candidate VLA2001 ■ Phase 1/2 initial data reported, Phase 3 data expected in Q3 2021 ■ Regulatory submission planned autumn 2021 assuming clinical data positive Further supply deals subject to negotiations and capacity V Valneva - Roadshow Presentation April 2021 39#40Q&A Session#41Thank you Merci Danke Tack Vvalneva

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Fiscal 3Q Investor Presentation image

Fiscal 3Q Investor Presentation

Healthcare

FY23 Full-Year Results Presentation image

FY23 Full-Year Results Presentation

Healthcare

Healthcare Network P&L Statement and Expansion Projects image

Healthcare Network P&L Statement and Expansion Projects

Healthcare

Accreditation and Quality Assurance Overview image

Accreditation and Quality Assurance Overview

Healthcare

Investment Highlights image

Investment Highlights

Healthcare

Investor Presentation image

Investor Presentation

Healthcare

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update image

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update

Healthcare

BioAtla Investor Presentation Deck image

BioAtla Investor Presentation Deck

Healthcare