EX-99.2 3 exh_992.htm EXHIBIT 99.2

Exhibit 99.2

 

Valneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate (“S4V”) August 01, 2024

 

 

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 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 provided as of the date of this presentation only and does not purport to be comprehensive . Any information in this presentation is purely indicative and subject to modification at any time without notice . Valneva does not warrant the completeness, accuracy or correctness of the information or opinions contained in this presentation . None of Valneva, or any of its affiliates, directors, officers, advisors and employees is under any obligation to update such information or shall bear any liability for any loss arising from any use of this presentation . The information has not been subject to independent verification and is qualified in its entirety by the business, financial and other information that Valneva is required to publish in accordance with the rules, regulations and practices applicable to companies listed on Euronext Paris and the NASDAQ Global Select Market, including in particular the risk factors described in Valneva’s universal registration document filed with the French Financial Markets Authority ( Autorité des Marchés Financiers , or AMF) on March 22 , 2024 ( document d’enregistrement universel 2023 ) under number D . 24 - 0157 (the “ 2023 URD”), and in the Form 20 - F filed with the U . S . Securities and Exchange Commission (SEC) on March 22 , 2024 , as well as the information in any other periodic report and in any other press release, which are available free of charge on the websites of Valneva (www . valneva . com) and/or the AMF (www . amf - france . org) and SEC ( www . sec . gov ) . Certain information and statements included in this presentation are not historical facts but are forward - looking statements, including with respect to business partnerships, the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products . 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 This presentation presents information about investigational vaccine candidates that have not been approved for use and have not been determined by any regulatory authority to be safe or effective . Management uses and presents IFRS results, as well as the non - IFRS measure of Adjusted EBITDA to evaluate and communicate its performance . While non - IFRS measures should not be construed as alternatives to IFRS measures, management believes non - IFRS measures are useful to further understand Valneva's current performance, performance trends, and financial condition . Adjusted EBITDA is a supplemental measure of performance used by investors and financial analysts . Management believes this measure provides additional analytical tools . 2 Valneva / LimmaTech - Shigella Partnership

 

 

1 Low - and middle - income countries Opportunity to develop first - in - class vaccine for a life - threatening disease Expected to provide near - term R&D upside for investors with appealing risk - benefit profile 3 Aligned with Our Vision ▪ Addresses significant unmet medical need; Shigellosis is devastating for infants and children in LMICs 1 ▪ An important public health goal, considering potential for herd immunity protection from all - cause diarrhea ▪ Rising antimicrobial - resistant enteric bacteria Aligned with Our Mission ▪ Differentiated asset with potential for first - in - class vaccine solution ▪ Augments clinical stage pipeline – anticipated Phase 3 initiation post potential Lyme approvals (2027) ▪ Potential “Plug - and play” with existing vaccine portfolio (Travel, Military, LMIC) Aligned with Our Corp. Strategy ▪ Expected to provide near - term R&D upside for investors ▪ Aligns with mid - term R&D capital allocation strategy and guidance ▪ Risk - mitigating, staggered development plan: multiple catalysts and decision points Valneva / LimmaTech - Shigella Partnership

 

 

Strategic Partnership with LimmaTech Biologics (“LMTB”) Valneva / LimmaTech - Shigella Partnership 4 1 https://lmtbio.com/wp - content/uploads/2024/02/20240221_LimmaTech_Shigella - Interim - Data - PR_Final.pdf Valneva gains exclusive worldwide rights to world’s most clinically advanced tetravalent Shigella program (“S4V”) LMTB Vaccine candidate “S4V” ▪ World’s most clinically advanced tetravalent Shigellosis vaccine candidate ▪ Tetravalent bioconjugate vaccine for prevention of disease caused by Shigella bacteria ( O - antigens of S. flexneri 2a, 3a, 6 and S. sonnei ) ▪ Developed following positive proof - of - concept clinical data with monovalent vaccine candidate, which demonstrated promising efficacy in challenge model ▪ LMTB reported positive Phase 1/2 clinical data on S4V, including robust immunogenicity against all strains; favorable safety and tolerability 1 ▪ Clinical - stage biotech company with decades of expertise in vaccine technology and disease - specific vaccine development approaches ▪ Backed by specialist healthcare investors ▪ Expanding a pipeline focused on innovative vaccine candidates against antimicrobial - resistant pathogens ▪ Multi - valent bioconjugate vaccine against E. coli developed with Janssen and acquired by Sanofi; now in Phase 3 ▪ Long - term partnerships with Pharma and NGOs

 

 

Shigellosis: Significant Unmet Medical Need 1 No approved Shigella vaccine is currently available Valneva / LimmaTech - Shigella Partnership 5 ▪ Second - leading cause of fatal diarrheal disease worldwide ▪ Estimated to cause up to 165 million cases and 600,000 deaths each year, particularly among children in LMICs 2 ▪ Caused by species of Shigella bacteria 1 . Shigellosis | CDC Yellow Book 2024 ; 2. Low - and - middle - income countries ▪ Highly contagious; person - to - person (directly or by contaminated materials), food - and water - borne transmissions are common ▪ Illness typically begins 1 – 2 days after exposure with symptoms lasting 5 – 7 days. Symptoms include diarrhea, fever and stomach cramps between others. Long term consequences can develop in children (linear growth faltering, stunting) a nd adults (arthritis). ▪ Considering the potential for herd immunity and protection from all - cause diarrhea, the development of a Shigella vaccine is an important goal for public health - priority for the World Health Organization (WHO) ▪ Shigella is a rising antimicrobial - resistant (AMR) enteric bacteria – hence a vaccine may indirectly impact the emergence of AMR

 

 

Potential first - in class vaccine, estimated >$500 million global market 1 Committed to providing equitable access to novel vaccines² Product ▪ 4 - valent Shigella bio - conjugate vaccine ( S. flexneri 2a, 3a, 6 and S. sonnei O - antigens) Indication ▪ Prevention of Shigellosis caused by vacci ne strains ▪ Shigellosis defi ned as severe or moderate diarrhea or dysentery Storage ▪ 2 - 8 ° C; expected shelf life >24 months Travelers/Military LMIC Population ▪ Travelers to endemic areas Registration Administration ▪ Intramuscular injection ▪ One or two doses, dependin g on the target population ▪ Leverage Phase 2 CHIM results for immuno - bridging to remaining S. flexneri serotypes 3a and 6 ▪ F ocus on FDA and EMA accelerated approval pathway (18+ years at launch, down to age 1) ▪ Children <5 years of age living in endemic areas ▪ Sublicense to Global Health Partner(s) to make products available to non - profit/public sector purchasers ▪ Consider applicability for private LMIC markets either directly or via partners ▪ WHO Pre - qualification Valneva / LimmaTech - Shigella Partnership 6 1 Valneva assessment, 2. Supporting Valneva ´ s ESG objectives

 

 

Risk - mitigating and staggered development plan Risk - mitigated clinical strategy allows for efficient capital allocation in line with mid - term guidance 1 Accountable for conduct and payment; 2. Controlled human infection model Valneva / LimmaTech - Shigella Partnership 7 Anticipated read - out Objective Anticipated start Accountable Party 1 Anticipated Clinical Development H2/2025 Dose confirmation, efficacy read - out H2/2024 LMTB CHIM 2 – Adults ( S. sonnei ) Phase 2 H2/2025 Dose confirmation, immunogencity H2/2024 LMTB Pediatric (Global Health) H2/2026 Efficacy read - out H2/2025 VLA CHIM – Adults ( S. flexneri 2a) H2/2029 Efficacy read - out H2/2027 VLA CHIM – Adults Phase 3 H2/2029 Efficacy read - out H2/2027 VLA Field efficacy Pediatric H2/2029 Safety/Immunogenicity/lot - to lot etc. H1/2028 VLA Additional pivotal H2/2030 H2/2029 First approval Multiple catalysts and decision points for envisaged development strategy

 

 

Strategic Partnership with LMTB on Shigella candidate S4V Key terms ▪ VLA receives global exclusive license to develop, manufacture and commercialize “S4V ” (4 valent (flexneri 2a, 3a, 6 and sonnei O - antigens) bio - conjugate vaccine for the prevention of a disease caused by Shigella) ▪ LMTB to receive upfront, is eligible for future milestone and royalty payments  €10 million upfront payment  Future development, regulatory and sales - based milestone payments totaling up to €40 million  Low double - digit royalty on net sales in the travel segment  Additional payments and single - digit royalties based on commercialization in LMICs ▪ Parties to collaborate through Phase 2  LMTB to conduct first Phase 2 “human challenge” study (CHIM trial ( S. sonnei )) and pediatric immunogenicity study in LMICs  Valneva to initiate second Phase 2 “human challenge” study (CHIM trial)( S. flexneri 2a)  LMTB to conduct technology transfer and transfer of IND 1 to Valneva once all Phase 2 studies are fully enrolled ▪ Valneva to lead and manage all future development activities 1 Investigational New Drug Application Valneva / LimmaTech - Shigella Partnership 8

 

 

Commercial Phase 3 Phase 2 Phase 1 Pre - Clinical Vaccine Design Program IXIARO ® Commercial Products DUKORAL ® IXCHIQ ® VLA15: Lyme disease Clinical Programs VLA1553: Chikungunya S4V: Shigellosis VLA1601: Zika VLA2112: EBV Key Pre - Clinical Activities Various Enteric diseases Valneva’s Commercial and R&D Portfolio Further extending a unique, differentiated portfolio Only U.S./ EU approved vaccine against Japanese encephalitis Most clinically advanced Lyme vaccine program worldwide Potential for first/best - in - class Established Cholera (ETEC 1 ) vaccine approved in >30 countries World‘s first and only approved chikungunya vaccine (U.S., Canada); Review ongoing in Europe & Brazil Phase 3 adolescent study (Brazil) and Phase 2 pediatric study support potential label expansion 1 ETEC indication in some markets only; 2 Controlled human infection model Phase 2 CHIM 2 and pediatric studies to begin H2 2024 Valneva / LimmaTech - Shigella Partnership 9

 

 

Thank you Merci Danke Tack