Valerio Therapeutics SA

PARIS, France I September 30, 2024 I Valerio Therapeutics S.A. (Euronext Growth Paris: ALVIO), a clinical-stage biotechnology company leading the way in the development of innovative DNA Decoy therapeutics, today announced the acquisition of Emglev Therapeutics, a spinoff of Institut Curie, one of France’s leading cancer centers. Valour Bio has been established as a wholly owned subsidiary of Valerio Therapeutics to focus on discovering single domain antibodies (sdAbs) as drug and radio conjugates, bispecific T-cell engagers, blocking and binding sdAbs, or CAR-T sdAb drug candidates for multiple therapeutic areas. Emglev’s proprietary synthetic sdAb libraries overcome the current barriers of conventional antibody discovery by providing unique targets and selecting humanized or fully human sdAbs entirely in vitro. These sdAbs are validated for a wide array of therapeutic applications, offering a distinct advantage in antibody development. Animal free sdAb screening strategies exploit highly diverse synthetic libraries and functional screening, enabling the identification of validated lead binders in less than two months. Since Emglev’s antibody scaffold is already humanized or derived from human variable region of the heavy chain (VH), there is no need for further humanization, thereby streamlining the development process and reducing the risk of immunogenicity and loss of affinity. Emglev’s sdAb technology has broad applications in several therapeutic areas such as inflammatory disorders, autoimmune diseases and cancer, but it also allows for the development of various treatment modalities including sdAb drug and radio-conjugates, bispecific T-cell engagers, blocking and binding sdAb or CAR-T sdAb drugs to name a few. Pre-clinical proof-of-concept of the sdAb technology has been obtained using CAR-T sdAb, BiTE sdAb and sdAb-drug conjugate, highlighting the ability of Emglev to rapidly and efficiently discover tailored antibody fragments with enhanced properties. Added to the expertise brought by Valerio Therapeutics, this positions Valour Bio with a versatile and promising platform for developing new best-in-class or first-in-class therapies for a wide range of diseases. The acquisition is structured through a sale of shares paid in cash and a contribution in kind of Emglev shares against Valour Bio shares. As a result, shareholders of Emglev became shareholders of Valour Bio. Dr. Shefali Agarwal , President & Chief Executive Officer of Valerio Therapeutics and CEO of Valour Bio, stated: “ The acquisition of Emglev Therapeutics through our newly formed subsidiary Valour Bio reinforces our commitment to bring innovative therapeutics to patients. We are excited to advance this next-generation technology developed by the accomplished scientists at Emglev and we look forward to the novel treatments this platform may yield like sdAb drug and radio -conjugates, bispecific T-cell engagers, blocking and binding sdAb or CAR-T sdAb drugs. Furthermore, we believe that the versatility of this platform can not only target a wide array of antigens but potentially address current limitations of antibody-based therapeutics such as tissue penetration, immunogenicity and ease of manufacturing. Following this acquisition, Valour Bio will focus on optimizing the therapeutic use of single-domain antibodies, focusing on developing treatments for severe and life-threatening diseases, including but not limited to autoimmune and inflammatory diseases as well as cancers .” Christelle Masdeu , CEO of Emglev Therapeutics, commented: “ We are excited to enter into this joint effort with Valerio Therapeutics. As a shareholder of Valour Bio now holding the Emglev platform, we remain committed to investing our energy, expertise and passion to develop unique treatments addressing unmet medical needs. The synergy created by combining Emglev’s proprietary synthetic single-domain antibody platform with Valerio’s distinctive preclinical and clinical development expertise perfectly aligns with our mission to deliver transformative therapies that make a meaningful difference in patients’ lives .” Dr. Sandrine Moutel , Emglev’s co-founder and head of the Antibody facility at Institut Curie and Dr. Franck Perez , Emglev’s co-founder and a member of its scientific board, director of the Cell Biology and Cancer Unit at Institut Curie, stated jointly: “ As founding members of Emglev, we are delighted to enter into this agreement which represents the culmination of tireless work by a dedicated team of scientists. Our team has created a platform that can generate therapeutics including CAR-Ts, T-cell engagers, binders, and bispecifics sdAbs demonstrating wide and versatile applicability to many diseases. This new chapter allows us to bring our vision of single-domain antibodies one step closer to the clinic and we are looking forward to beginning this journey with Valerio Therapeutics .” Cécile Campagne , Director of Institut Curie’s Technology Transfer Office, declared: “ We are proud of the path taken by Emglev Therapeutics, a start-up that has emerged from Institut Curie’s incubation program, which is moving forward at full speed! The acquisition of Emglev, less than two years after its creation, by Valour Bio, a subsidiary of Valerio Therapeutics which is a listed company, reflects the quality of Institut Curie’s innovations and the importance of putting them at the service of the creation of companies that will bring these cutting-edge technologies to all patients. ” To this end, Valerio Therapeutics will provide Valour Bio with services in terms of scientific know-how in drug development, company support and equipment against financial compensation. Given the potential of the technology and depth of the market potential, Valour Bio is confident that it will find the needed financial resources to support the company’s growth. The acquisition and operation of Emglev will enable new scientific and financial synergies to be created within the Valerio Group, with the first benefits for Valerio Therapeutics and Valour Bio expected to materialize in Q1 2025. About Valour Bio Valour Bio is a discovery stage biotechnology company established through acquisition of Emglev’s unique proprietary single-domain antibody platform in September 2024. Valour Bio was established as a subsidiary of Valerio Therapeutics. Through pioneering science, strategic partnerships, and an unwavering commitment to enhancing patient outcomes, we strive to deliver hope and advance healthcare for those who need it most. For further information, please visit valourbio.com About Valerio Therapeutics Valerio Therapeutics is a clinical-stage biotechnology company developing innovative oncology drugs targeting tumor DNA-binding functions through unique mechanisms of action in the sought-after field of DNA Damage Response (DDR). The Company is focused on bringing early-stage first-in-class or disruptive compounds from translational research to clinical proof-of-concept, a value-creating inflection point appealing to potential partners. For further information, please visit valeriotx.com About Emglev Therapeutics Emglev Therapeutics is a biotechnology company established in 2023 as a spin-off of Institut Curie dedicated to the discovery and the development of transformative immunotherapies to address unmet medical needs in oncology. By leveraging its unique proprietary platform, the Company unlocks the current barriers of conventional antibody discovery to provide unique targets and sdAbs selected fully in vitro and validated for therapeutic applications in any format against any target. The Company is focused on the development the next level of immunotherapies for the benefit of all the patients with high unmet needs. For further information, please visit www.emglev-tx.com SOURCE: Valerio Therapeutics

Emglev Therapeutics has expertise in the development of therapeutic solutions based on sDAbs. Credit: THICHA SATAPITANON via Shutterstock. Valerio Therapeutics, a developer of DNA Decoy therapeutics, has announced its acquisition of Emglev Therapeutics, a company specialising in single-domain antibody-based therapeutics. This strategic move aims to enhance Valerio’s drug development capabilities across multiple therapeutic areas. Emglev Therapeutics, originating from Institut Curie, has developed synthetic single-domain antibody (sdAb) libraries that address the limitations of traditional antibody discovery. These libraries enable the identification of humanised or fully human sdAbs completely in vitro, offering a significant edge in antibody development. Valerio Therapeutics president and CEO Dr Shefali Agarwal said: “The acquisition of Emglev Therapeutics through our newly formed subsidiary Valour Bio reinforces our commitment to bring innovative therapeutics to patients. See Also: mRNA Covid-19 vaccines may boost cancer immunotherapy effectiveness J&J clinches EC approval for first single-pill PAH combo “We are excited to advance this next-generation technology developed by the accomplished scientists at Emglev and we look forward to the novel treatments this platform may yield like sdAb drug and radio-conjugates, bispecific T-cell engagers, blocking and binding sdAb or CAR-T sdAb drugs.” Emglev’s sdAb technology, which is already humanised, accelerates the development process and minimises immunogenicity risks. With broad applications in autoimmune diseases, inflammatory disorders and cancer, the technology supports the development of various treatment modalities. These include drug and radio-conjugates, CAR-T sdAb drugs, bispecific T-cell engagers, among others. Preclinical proof-of-concept has been demonstrated with CAR-T sdAb, BiTE sdAb, and sdAb-drug conjugates, showcasing Emglev’s ability to discover tailored antibody fragments. Emglev Therapeutics CEO Christelle Masdeu said: “As a shareholder of Valour Bio now holding the Emglev platform, we remain committed to investing our energy, expertise and passion to develop unique treatments addressing unmet medical needs. “The synergy created by combining Emglev’s proprietary synthetic single-domain antibody platform with Valerio’s distinctive preclinical and clinical development expertise perfectly aligns with our mission to deliver transformative therapies that make a meaningful difference in patients’ lives.”

Saint-Herblain (France), June 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Board of Directors were approved by the shareholders at its Combined General Meeting (CGM) held today in Lyon, France. Among the adopted resolutions were approval of the 2023 financial statements, delegations for the management board to increase Valneva’s share capital and/or issue financial instruments, and the appointment of a new director to its Board. Ms. Danièle Guyot-Caparros was appointed to Valneva’s Board of Directors for a three-year term. Ms. Guyot-Caparros has a proven track record in finance and business operations. She started her career in Audit and Corporate Finance with PWC specializing in the Chemical/Pharma Industry. In 1992, she joined Rhône-Poulenc-Rorer (later Aventis and Sanofi) where she held several senior finance positions (CFO Global R&D, CFO Europe, Group Planning). She also held responsibilities in business development, pricing, and portfolio management. In 2008, she became Senior Advisor for Deloitte France to support the development of the Life Sciences and Health Care Industry practice. Ms. Guyot-Caparros is also an experienced non-executive director with a focus on Biotech/Medtech. She sat on Diaxonhit’s (now Eurobio Scientific) and ONXEO’s Board of Directors and chaired Supersonic Imagine’s and ONXEO’s audit committees. In October 2022, she joined the board of DBV Technologies, listed on Euronext Paris and Nasdaq, and is member of the audit committee as well as of the compensation committee. She is a graduate from ICN (Institut Commercial de Nancy), with a major in finance and accounting. She holds a chartered accountant degree and a certificate of corporate governance/non-executive director from IFA-Science-Po. The AGM’s voting results will be made available in the “Investors & Media” section of Valneva’s corporate website in the coming days. About Valneva SEWe 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, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.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 Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to 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. 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 during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Attachment 2024_06_26_VLA_Post_CGM_PR_EN_Final