LimmaTech Biologics AG

SAINT HERBLAIN, France and SCHLIEREN, Zurich I November 13, 2024 I Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG , a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participant has been vaccinated in a Phase 2b controlled human infection model (CHIM) study of Shigella4V2 (S4V2), the world’s most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech 1 . In the CHIM study S4V03 (Identifier: NCT06615375 ), S4V2 will be tested for safety and preliminary efficacy in approximately 120 healthy Shigella -naïve participants aged 18 to 50 years at three sites in the United States. The study, sponsored and conducted by LimmaTech, is a parallel-group, randomized, double-blind, multicenter, placebo-controlled study and will include two steps. In a first step, the vaccine dose will be confirmed and, in a second step, participants will be challenged with the Shigella sonnei strain 53G one month after injection of S4V2 or placebo, in order to assess the ability of S4V2 to protect against the Shigella infection. The infection rate of shigellosis caused by the Shigella sonnei strain 53G in the group vaccinated with S4V2 will then be compared to the group of participants who received placebo injections. Thomas Lingelbach, Chief Executive Officer of Valneva , commented, “Human challenge studies are unique in their ability to investigate and understand the onset and development of disease in a safe and highly controlled environment. This CHIM study forms part of our staggered and risk-mitigating development strategy for S4V2, as it should provide the first results on efficacy before potentially advancing to further CHIM and Phase 3 studies.” Dr. Patricia Martin, Chief Operating Officer of LimmaTech, stated, “The start of this trial is a significant milestone for the S4V2 program and our combined efforts with Valneva to bring an effective vaccine against shigellosis to market. Today, we are an important step closer to LimmaTech’s vision of developing vaccines to fight against serious diseases and antimicrobial resistant pathogens.” In addition to the CHIM study, LimmaTech will conduct a Phase 2 pediatric study in Low- and Middle-Income Countries expected to begin before the end of 2024. Valneva will assume all further development, including CMC (chemistry, manufacturing and controls) and regulatory activities, and be responsible for its commercialization worldwide, if approved. Last month, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to S4V2, recognizing its potential to address a serious condition and fill an unmet medical need 2 . Shigellosis is the second leading cause of fatal diarrheal disease worldwide. However, there is currently no approved Shigella vaccine and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO) 3 . About Shigellosis Shigellosis is a global health threat caused by the Gram-negative Shigella bacteria. It is estimated that up to 165 million infections 4 are due to Shigella of which 62.3 million occur in children younger than five years. Diarrheal infection is one of the major causes of morbidity and mortality in numerous countries as well as in travelers and deployed military personnel in endemic regions. There are an estimated 600,000 deaths attributed to Shigella each year and it is the second leading cause for diarrheal deaths 5 . The standard treatment for shigellosis is oral rehydration and antibiotic therapy, however, the bacteria have acquired resistance to many antibiotics with numerous reports of outbreaks of multidrug-resistant strains, making treatment extremely difficult. Currently, no licensed Shigella vaccine is available. About Valneva SE We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com . About LimmaTech Biologics AG LimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections. With decades of expertise and an expanding, robust pipeline, the LimmaTech team is dedicated to generating protective solutions to deliver transformative value worldwide. LimmaTech Biologics is backed by specialist healthcare investors, including Adjuvant Capital, AXA IM Alts, Novo Holdings REPAIR Impact Fund, and Tenmile. For more information, please visit www.lmtbio.com . 1 LimmaTech Biologics AG 2 Valneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V – Valneva 3 Immunization, Vaccines and Biologicals (who.int) 4 Shigellosis | CDC Yellow Book 2024 5 Shigellosis | CDC Yellow Book 2024 SOURCE: Valneva

COPENHAGEN, Denmark, Nov. 14, 2024 /PRNewswire/ -- MinervaX ApS, a privately held Danish biotechnology company developing a novel, prophylactic vaccine against Group B Streptococcus (GBS), today announced the appointment of Veronica Gambillara Fonck as its new Chair of the Board of Directors. Gerd Zettlmeissl, the previous Chair, who was instrumental in the transition of MinervaX from a preclinical-stage company to a well-funded clinical-stage company, has stepped down from his role for personal reasons but will continue to support MinervaX as a senior advisor. Veronica has been a board member of MinervaX since 2022, following an investment by Pureos Bioventures, where she has served as a Partner since 2022. She has over 18 years of experience across the pharma and biotech industry in various operational roles in vaccine development and has been instrumental in building and growing companies. Veronica was the Co-Founder and CEO of LimmaTech Biologics, a company developing vaccines to prevent life-threatening diseases caused by pathogens resistant to antimicrobial treatments, and GlycoEra AG, a biotech company developing medicines for a variety of diseases using its CustomGlycan platform. Per Fischer, Chief Executive Officer of MinervaX, said: "Veronica has been a key member of our board since October 2022 and her extensive vaccine development experience has been invaluable in the progress of our novel, prophylactic vaccine candidate against GBS. Veronica in her new role as Chair will oversee the next important phase of company development as we prepare for Phase III studies with our maternal GBS vaccine. I would like to thank Gerd for his valuable contributions to the success of MinervaX over the past four years, and we are pleased that we will continue to benefit from his vast experience in his new advisory role." Veronica Gambillara, new Chair of the Board of Directors of MinervaX, commented: "I am thrilled to be taking on this role at such a pivotal stage of development for MinervaX as we advance towards Phase III studies with our GBS vaccine in pregnant people and advance our Phase I studies in older adults. GBS remains a significant unmet medical need, and I look forward to working closely with the board and management team to achieve the full potential of our GBS vaccine to prevent these life-threatening infections." Veronica began her career focusing on clinical R&D and international regulation within the MedTech field. In 2009, she moved to GlycoVaxyn, a specialist vaccine biopharmaceutical company where she held roles in clinical, regulatory, and business development. Veronica was a core member of the GlycoVaxyn team responsible for building and contributing to the success of the company in preparation for its acquisition by GSK in 2015 for $190 million. She is also a board member at Memo Therapeutics. The new Chair appointment follows the recently announced manufacturing agreement with Wacker Biotech in September as MinervaX begins establishing commercial manufacturing for its GBS vaccine candidate. GBS is a major global cause of maternal and infant ill health with no approved vaccine available to prevent the rising early and late onset of GBS. The rising number of GBS cases reported globally each year has reached 410,000 with approximately 147,000 stillbirths and infant deaths reported each year, demonstrating the urgent need for an approved GBS vaccine. Notes to Editors: About MinervaX MinervaX is a Danish biotechnology company, established in 2010 to develop a prophylactic vaccine against Group B Streptococcus (GBS), based on research from Lund University. MinervaX is developing a GBS vaccine for maternal immunization, and also for vaccination of older/at risk adults. Phase II clinical data from its maternal vaccination program suggest a high efficacy, based on the preliminary Correlate of Protection data from a natural history study. MinervaX's GBS vaccine is a protein-only vaccine based on fusions of highly immunogenic and protective protein domains from selected surface proteins of GBS, the Alpha-like protein family (AIpN). Given the broad distribution of proteins contained in the vaccine on GBS strains globally, it is expected that MinervaX's GBS vaccine will confer protection against virtually 100% of all GBS isolates. Details of MinervaX's completed Phase II clinical trials in pregnant people can be found at under the identifiers NCT04596878 and NCT05154578. In addition to pregnant people, MinervaX is also pursuing Phase I development of its novel GBS vaccine in older adults, under identifier NCT05782179. SOURCE MinervaX ApS WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Saint Herblain (France) and Schlieren (Zurich), November 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participant has been vaccinated in a Phase 2b controlled human infection model (CHIM) study of Shigella4V2 (S4V2), the world’s most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech1. In the CHIM study S4V03 (Identifier: NCT06615375), S4V2 will be tested for safety and preliminary efficacy in approximately 120 healthy Shigella-naïve participants aged 18 to 50 years at three sites in the United States. The study, sponsored and conducted by LimmaTech, is a parallel-group, randomized, double-blind, multicenter, placebo-controlled study and will include two steps. In a first step, the vaccine dose will be confirmed and, in a second step, participants will be challenged with the Shigella sonnei strain 53G one month after injection of S4V2 or placebo, in order to assess the ability of S4V2 to protect against the Shigella infection. The infection rate of shigellosis caused by the Shigella sonnei strain 53G in the group vaccinated with S4V2 will then be compared to the group of participants who received placebo injections. Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “Human challenge studies are unique in their ability to investigate and understand the onset and development of disease in a safe and highly controlled environment. This CHIM study forms part of our staggered and risk-mitigating development strategy for S4V2, as it should provide the first results on efficacy before potentially advancing to further CHIM and Phase 3 studies.” Dr. Patricia Martin, Chief Operating Officer of LimmaTech, stated, “The start of this trial is a significant milestone for the S4V2 program and our combined efforts with Valneva to bring an effective vaccine against shigellosis to market. Today, we are an important step closer to LimmaTech’s vision of developing vaccines to fight against serious diseases and antimicrobial resistant pathogens.” In addition to the CHIM study, LimmaTech will conduct a Phase 2 pediatric study in Low- and Middle-Income Countries expected to begin before the end of 2024. Valneva will assume all further development, including CMC (chemistry, manufacturing and controls) and regulatory activities, and be responsible for its commercialization worldwide, if approved.Last month, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to S4V2, recognizing its potential to address a serious condition and fill an unmet medical need2. Shigellosis is the second leading cause of fatal diarrheal disease worldwide. However, there is currently no approved Shigella vaccine and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO)3. About ShigellosisShigellosis is a global health threat caused by the Gram-negative Shigella bacteria. It is estimated that up to 165 million infections4 are due to Shigella of which 62.3 million occur in children younger than five years. Diarrheal infection is one of the major causes of morbidity and mortality in numerous countries as well as in travelers and deployed military personnel in endemic regions. There are an estimated 600,000 deaths attributed to Shigella each year and it is the second leading cause for diarrheal deaths5. The standard treatment for shigellosis is oral rehydration and antibiotic therapy, however, the bacteria have acquired resistance to many antibiotics with numerous reports of outbreaks of multidrug-resistant strains, making treatment extremely difficult. Currently, no licensed Shigella vaccine is available. About Valneva SE We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines.Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com. About LimmaTech Biologics AGLimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections. With decades of expertise and an expanding, robust pipeline, the LimmaTech team is dedicated to generating protective solutions to deliver transformative value worldwide. LimmaTech Biologics is backed by specialist healthcare investors, including Adjuvant Capital, AXA IM Alts, Novo Holdings REPAIR Impact Fund, and Tenmile.For more information, please visit www.lmtbio.com. Valneva Investor and Media ContactsLaetitia Bachelot-FontaineVP Global Communications & European Investor RelationsM +33 (0)6 4516 7099laetitia.bachelot-fontaine@valneva.com Joshua Drumm, Ph.D.VP Global Investor RelationsM +001 917 815 4520joshua.drumm@valneva.com For LimmaTechLimmaTech Biologics AGFranz-Werner Haas, CEOE-mail: media@lmtbio.com For media enquiriesTrophic CommunicationsGretchen Schweitzer or Jacob VerghesePhone: +49 172 861 8540E-mail: limmatech@trophic.eu Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to financial results for 2024; mid-term revenue and cash outlook; the progress, timing, results and completion of research, development and clinical trials for product candidates; regulatory approval of product candidates and requested label extensions; and review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 LimmaTech Biologics AG2 Valneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V - Valneva3 Immunization, Vaccines and Biologicals (who.int)4Shigellosis | CDC Yellow Book 20245 Shigellosis | CDC Yellow Book 2024 Attachment 2024_11_13_CHIM_Study_S4V2_PR_EN.Final