Bacterial outer membrane proteins

Designation underlines the need for novel, first-in-class antimicrobials for the treatment of infections with Gram-negative bacteria JERUSALEM, Israel, February 20, 2023 -- Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced that the Company has received fast-track designation for its novel anti-infective OMN6 from the U.S. Food and Drug Administration (FDA). Fast track expedited review is designated to investigational drugs that treat a serious or life-threatening condition and fill an unmet medical need. OMN6 is Omnix Medical´s lead compound and a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) fundamentally differs from conventional anti-infectives by physically destroying bacterial cell membranes and allowing a fast and effective onset of action regardless of bacterial genotype or resistance phenotype. In November 2023, Omnix Medical had been granted an IND for a Phase II trial of OMN6 in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC). Both are life-threatening infections that currently lack fast and effective treatments, most of which fall short due to antimicrobial resistances. "We are excited that the U.S. FDA has granted fast-track designation for our lead compound OMN6," said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical. "This allows us to accelerate the development of game-changing anti-infectives that are designed to be fast-acting and effective without triggering antimicrobial resistances. We are looking forward to obtaining Phase II results." “The fast-track designation brings us one step closer to saving the lives of patients with life-threatening hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) that do not respond to conventional antibiotics and currently have no further therapeutic options,” added Niv Bachnoff, CSO of Omnix Medical. ### About Omnix Medical Omnix Medical was founded in 2015 to address the urgent unmet need for new life-saving anti-infective drugs. Omnix´ proprietary technology eliminates bacteria by mimicking the innate immune system of insects which uses unique molecules to efficiently and selectively kill resistant bacterial strains without toxic effects. This mechanism, which is at the core of Omnix´ technology, kills bacteria upon contact and has successfully evolved over 200 million years. The Company’s lead compound is being developed for the treatment of life-threatening hospital-acquired infections (HIA) and has shown significantly higher potency than currently available treatments. Most importantly, Omnix´ technology prevents the development of new resistances and is thus well positioned to become the first-line-treatment to win the war against AMR. About OMN6 OMN6 is a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) is based on disruption of bacterial cell membranes and is therefore effective regardless of bacterial genotype or resistance phenotype, and unlike conventional bacteriostatic antibiotics, it is fast acting and bactericidal. OMN6 has been optimized from the original AMP by Omnix Medical´s proprietary technology to exhibit not only remarkable efficacy, potency, and safety, but also high stability while maintaining bioactivity. As a result, Omnix Medical believes that its novel peptides can be considered a new class of antimicrobial drugs. OMN6, the Company's lead compound, is intended for the treatment of life-threatening infections caused by Gram-negative bacteria such as Acinetobacter baumannii. Corporate Contacts Moshik Cohen-Kutner, CEO +972-50-8698218 Niv Bachnoff, CSO +972-54-238-6023 contact@omnixmedical.com Media Inquiries akampion Dr. Ludger Wess / Ines-Regina Buth Managing Partners info@akampion.com Tel. +49 40 88 16 59 64 / Tel. +49 30 23 63 27 68 Related Links Twitter LinkedIn

Strong immune response shown in both children and adolescents one month after booster dose (month 19) in VLA15-221 study Previously observed high anamnestic antibody response in adults confirmed VLA15 well-tolerated in all age groups following booster dose Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE) announced today positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster. These results from the VLA15-221 Phase 2 study showed a strong anamnestic antibody response for all serotypes in pediatric (5 to 11 years of age) and adolescent participants (12 to 17 years of age), as well as in adults (18 to 65 years of age), one month after administration of a booster dose (month 19). Depending on the primary schedule they received (month 0-2-6 or month 0-6), participants seroconverted after the booster dose, yielding seroconversion1 rates (SCRs) of 95.3% and 94.6% for all outer surface protein A (OspA) serotypes in all age groups, respectively. Additionally, OspA antibody titers were significantly higher one month after the booster dose compared to one month after the primary schedule with 3.3- to 3.7-fold increases (Geometric Mean Fold Rises) in adults, 2.0- to 2.7- fold increases in adolescents and 2.3- to 2.5-fold increases in children for all serotypes. Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “We are pleased with these data which validate the use of a booster dose in all age groups. Lyme disease continues to spread, representing an important unmet medical need that impacts the lives of many people in the Northern Hemisphere. With each new set of positive data, we come one step closer to potentially bringing this vaccine to both adults and children living in areas where Lyme disease is endemic.” The Phase 2 booster results emphasize the vaccine candidate’s potential to provide immunity against Lyme disease in pediatric and adolescent populations. Geometric Mean Titers (GMTs) one month following the booster dose were similarly high for children and adolescents. The safety and tolerability profile of VLA15 after a booster dose was consistent with previous studies as the vaccine candidate was well-tolerated in all age groups regardless of the primary vaccination schedule. No vaccine-related serious adverse events (SAEs) and no safety concerns were observed by an independent Data Safety Monitoring Board (DSMB). “Protection against Lyme disease is important for anyone who lives or spends time outdoors in areas where Lyme disease is endemic. This data from the VLA15-221 study is vital to improve our understanding of how vaccination may help to protect both adults and children from this potentially devastating disease,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head Vaccine Research and Development at Pfizer. “We are encouraged by the positive Phase 2 results for VLA15, and, in partnership with Valneva, look forward to continuing to study the vaccine candidate in ongoing Phase 3 clinical trials.” These results follow six-month antibody persistence data in children and adults reported for the VLA15-221 study in December 20221 and positive immunogenicity and safety data reported in April 20222. In August 2022, Pfizer and Valneva initiated the currently ongoing Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), to investigate the efficacy, safety and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the United States (U.S.) and Europe3. A second Phase 3 study (VLA15-1012), aiming to provide further evidence on the safety profile of VLA15 in the pediatric population, is also ongoing. Pfizer aims to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2026, subject to positive Phase 3 data. About VLA15 There are currently no approved human vaccines for Lyme disease, and VLA15 is the most advanced Lyme disease vaccine candidate currently in clinical development, with a Phase 3 study in progress. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans. The vaccine covers the six most common OspA serotypes expressed by the Borrelia burgdorferi sensu lato species that are prevalent in North America and Europe. VLA15 has demonstrated a strong immune response and satisfactory safety profile in pre-clinical and clinical studies so far. Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.4,5 The program was granted Fast Track designation by the U.S. FDA in July 2017.6 About Clinical Study VLA15-221 VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study. It is the first clinical study with VLA15 which enrolled a pediatric population (5-17 years old). 585 healthy participants received VLA15 in two immunization schedules (month 0-2-6 [N=190] or month 0-6 [N=187]) or three doses of placebo (month 0-2-6 [N=208]). Vaccine recipients received VLA15 at a dose of 180 µg, which was selected based on data generated in the two previous Phase 2 studies. The main safety and immunogenicity readout was performed one month after the primary vaccination series. All eligible subjects received a booster dose of VLA15 or placebo at month 18 (booster phase) and will be followed for three additional years to monitor antibody persistence. In addition, all eligible subjects will be asked to receive an additional booster dose of VLA15 or placebo at month 30, in order to generate additional data and assess the need for periodic booster doses. VLA15 is tested as an alum-adjuvanted formulation and administered intramuscularly. The study is being conducted at U.S. sites located in areas where Lyme disease is endemic and has enrolled both volunteers with a prior infection with Borrelia burgdorferi as well as Borrelia burgdorferi-naïve volunteers. About Lyme Disease Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by the bite of an infected Ixodes ticks.7 It is considered the most common vector-borne illness in the Northern Hemisphere.8 While the true incidence of Lyme disease is unknown, it is estimated to annually affect approximately 476,000 people in the U.S. and 129,000 people in Europe.9,10 Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called Erythema migrans or more nonspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia or myalgia) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious complications affecting the skin, joints (arthritis), the heart (carditis) or the nervous system.9 The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.11 About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. About Valneva SE We are a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases. We take a highly specialized and targeted approach to vaccine development by focusing on vaccine solutions addressing unmet medical needs to ensure we can make a difference to peoples’ lives. We apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, and our established vaccine development capabilities, to develop vaccines against diseases which are not yet vaccine-preventable, or for which there are limited effective treatment options. Today, we are leveraging our expertise and capabilities to rapidly advance a broad range of vaccines into and through the clinic, including candidates against the chikungunya virus and Lyme disease. References Serconversion was defined as the proportion of subjects that changed from seronegative at baseline to seropositive or showed a ≥four-fold increase in IgG titers compared to baseline if tested OspA seropositive at baseline. Valneva and Pfizer Report Six-Month Antibody Persistence Data in Children and Adults for Lyme Disease Vaccine Candidate. December 2022. Available at: https://valneva.com/press-release/valneva-and-pfizer-report-six-month-antibody-persistence-data-in-children-and-adults-for-lyme-disease-vaccine-candidate/ Accessed: August 2023. Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate. April 2022. Available at: https://valneva.com/press-release/valneva-and-pfizer-report-positive-phase-2-pediatric-data-for-lyme-disease-vaccine-candidate/ Accessed: August 2023. Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15. August 2022. Available at: https://valneva.com/press-release/pfizer-and-valneva-initiate-phase-3-study-of-lyme-disease-vaccine-candidate-vla15/ Accessed: August 2023. Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15. April 2020. Available at: https://valneva.com/press-release/valneva-and-pfizer-announce-collaboration-to-co-develop-and-commercialize-lyme-disease-vaccine-vla15/ Accessed: August 2023. Valneva and Pfizer Enter into Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15. June 2022. Available at: https://valneva.com/press-release/valneva-and-pfizer-enter-into-an-equity-subscription-agreement-and-update-terms-of-collaboration-agreement-for-lyme-disease-vaccine-candidate-vla15/ Accessed: August 2023. Valneva Receives FDA Fast track Designation for its Lyme Disease Vaccine Candidate VLA15. July 2017. Available at: https://valneva.com/press-release/valneva-receives-fda-fast-track-designation-for-its-lyme-disease-vaccine-candidate-vla15/ Accessed: August 2023. Stanek et al. 2012, The Lancet 379:461–473 Centers for Disease Control and Prevention. Lyme Disease. January 2021. Available at : https ://www.cdc.gov/lyme/stats/humancases.html. Accessed: August 2023. Burn L, et al. Incidence of Lyme Borreliosis in Europe from National Surveillance Systems (2005–2020). April 2023. Vector Borne and Zoonotic Diseases. 23(4): 156–171. Kugeler KJ, et al. Estimating the frequency of Lyme disease diagnoses—United States, 2010-2018. February 2021. Emergency Infectious Disease. 27(2). Centres for Disease Control. Understanding Lyme and Other Tickborne Diseases. May 2022. Available from: https://www-cdc-gov.libproxy1.nus.edu.sg/ncezid/dvbd/media/lyme-tickborne-diseases-increasing.html Accessed: August 2023. The content above comes from the network. if any infringement, please contact us to modify.

Product sales increased 98.6% to €32.1 million in the first quarter of 2023 compared to €16.2 million in the first quarter of 2022 Driven by IXIARO® and DUKORAL® sales both of which more than quadrupled year-over-yearTotal revenues of €33.5 million in the first quarter of 2023 compared to €21.8 million in the first quarter of 2022 Strong cash position of €254.5 million at March 31, 2023 Chikungunya: progressing towards delivery of the world’s first chikungunya vaccine Prescription Drug User Fee Act (PDUFA) review goal date confirmed for end of August 2023 by the U.S. Food and Drug Administration (FDA) Additional regulatory submission process to be initiated in the second quarter of 2023 2023 financial guidance confirmed Expected total revenues and other income between €220 million and €260 million, including: €130 million to €150 million of product sales€90 million to €110 million of other income Expected R&D expenses between €70 million and €90 million Financial Information(Unaudited results, consolidated per IFRS) € in million 3 months ending March 31, 2023 2022 Total revenues 33.5 21.8 Product sales 32.1 16.2 Net loss (18.1) (26.0) Adjusted EBITDA1 (12.3) (13.3) Cash 254.5 311.3 Saint-Herblain (France), May 4, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its first quarter financial results ending March 31, 2023, and provided corporate updates. Valneva will provide a live webcast of its first quarter 2023 results conference call beginning at 3 p.m. CEST/9 a.m. EDT today. This webcast will also be available on the Company’s website. Please refer to this link: https://edge.media-server.com/mmc/p/82fytb7o Peter Bühler, Valneva’s Chief Financial Officer, commented, “We entered 2023 with good momentum as we managed to double our first quarter vaccine sales year-over-year, keeping us on track to deliver on our full year sales guidance of €130 million to 150 million. Our objective is to continue driving these sales in 2023 and, at the same time, continue to build a stronger vaccine portfolio and pipeline. As we approach our ten-year anniversary, we look forward to celebrating another major milestone with the potential approval of our chikungunya vaccine candidate in the U.S. later this year.” Clinical Stage Vaccine Candidates CHIKUNGUNYA VACCINE CANDIDATE – VLA1553FDA Mid-cycle review meeting for Biologics License Application (BLA) completed VLA1553 is a live-attenuated, single-dose vaccine candidate against the chikungunya virus (CHIKV), a mosquito-borne virus that has spread to more than 110 countries2 with the potential to rapidly expand further. The Pan American Health Organization (PAHO) issued an epidemiological alert in February 2023 as the number of cases and deaths due to chikungunya continues to rise in the Americas3. With no preventive vaccine or specific treatment yet available, chikungunya is considered a major public health threat. In February 2023, the FDA accepted the filing of a BLA for approval of VLA1553 in persons aged 18 years and above4, and at a recent mid-cycle review meeting, indicated that no significant review or safety concerns were noted. The FDA confirmed the Prescription Drug User Fee Act (PDUFA) review goal date at the end of August 2023, on which an approval decision on the VLA1553 BLA is expected. VLA1553 is currently the only chikungunya vaccine candidate worldwide for which a regulatory review process is underway5 and, if approved, it could become the first licensed chikungunya vaccine available to address this unmet medical need. It would also represent the third vaccine Valneva6 has brought from early R&D to approval. The sponsor of the first chikungunya vaccine approved in the U.S. is eligible to receive a Priority Review Voucher (PRV)7. Valneva’s BLA application follows final pivotal Phase 3 data in March 20228, final lot-to-lot consistency results in May 20229 and positive twelve-month persistence data in December 202210. A clinical study of VLA1553 in adolescents is ongoing in Brazil11, for which Valneva reported enrollment and vaccination completion in February 202312. This trial, conducted by Valneva’s partner Instituto Butantan and funded by the Coalition for Epidemic Preparedness Innovations (CEPI), may support future regulatory submissions in this age group, if VLA1553 is initially approved in adults, as well as licensure of the vaccine in Europe and Brazil, which would be the first potential approval for use in an endemic population. Topline results are expected mid-2023. The program received FDA Fast Track, Breakthrough Therapy and Priority Review designations in 2018, 2021 and 2023, respectively. VLA1553 was also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020. Valneva currently plans to make additional regulatory submissions for VLA1553 in Canada, Europe and the United Kingdom in 2023. LYME DISEASE VACCINE CANDIDATE – VLA15 Phase 3 study ongoing Valneva and Pfizer are developing VLA15, a Lyme disease vaccine candidate that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacterium that causes Lyme disease. VLA15 is a multivalent recombinant protein vaccine that targets six serotypes of Borrelia representing the most common strains found in North America and Europe. VLA15 is the only Lyme disease vaccine program in advanced clinical development today and has received Fast Track designation from the FDA. Valneva and Pfizer reported results for three Phase 2 clinical trials of VLA15 in both adult and pediatric populations, in which high levels of antibodies against all six strains were observed13,14,15. In August 2022, the companies initiated a Phase 3 clinical study, "Vaccine Against Lyme for Outdoor Recreationists (VALOR)", to investigate the efficacy, safety and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the United States and Europe16. The VALOR study is currently ongoing and, as communicated in February 2023, Pfizer had to discontinue approximately half of the total recruited participants in the trial following violations of Good Clinical Practice (GCP) at certain trial sites in the U.S. run by a third-party trial site operator. The clinical trial remains ongoing with other sites not operated by the third party, and Pfizer continues to enroll new participants at those sites in addition to newly added sites in the U.S. and Canada. The original study design and endpoints previously agreed with regulators have not changed. Currently enrolled participants will receive their booster vaccination as planned in the second quarter of 2024 in advance of the 2024 tick season. Additional enrollment for primary immunization will begin in the second quarter of 2023 with overall trial continuation to include the 2025 tick season. As a result, Pfizer is aiming to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2026, subject to positive data. Current projected incremental study execution costs incurred due to the agreed amount of additional enrollment will be borne by Pfizer”. Pre-Clinical Vaccine Candidates Valneva continues to progress select pre-clinical assets and focus on strengthening its future clinical pipeline. The Company is currently focused on VLA2112, a vaccine candidate targeting the Epstein-Barr virus (EBV), which is one of the most common human viruses. EBV can cause infectious mononucleosis17 and is strongly associated with the development of several types of cancer18 and multiple sclerosis19. Valneva is also developing a vaccine candidate targeting the human metapneumovirus (hMPV), which is a major worldwide respiratory pathogen that causes acute upper and lower respiratory tract infection20, and is currently exploring potential partnering opportunities. Additionally, Valneva initiated pre-clinical work on vaccine candidates targeting parvovirus B19, a virus, which can cause hydrops fetalis in pregnant women and aplastic crisis in persons with anemia21, as well as Campylobacter, a bacterium often associated with food poisoning22. Commercial Vaccines JAPANESE ENCEPHALITIS VACCINE (IXIARO®/JESPECT®) IXIARO® is an inactivated Vero cell culture-derived Japanese encephalitis that is the only Japanese encephalitis vaccine licensed and available in the United States, Canada and Europe. IXIARO® is indicated for active immunization against Japanese encephalitis, the most prevalent cause of viral encephalitis in Asia, for adults, adolescents, children and infants aged two months and older. IXIARO®/JESPECT® sales were €17.4 million in the first quarter of 2023 compared to €4.2 million in the first quarter of 2022. This 315.2% sales increase was driven by the significant recovery of the private travel markets following the decline of the COVID-19 pandemic as well as price increases. Valneva has started discussions with the U.S. Department of Defense (DoD) and expects to sign a new contract with the DoD in the coming months. Valneva is also exploring options for its Almeida manufacturing facility in Livingston (Scotland), initially built to produce its COVID-19 vaccine, including a possible sale or a repurposing to produce IXIARO® and its chikungunya vaccine, if approved. CHOLERA / ETEC23-DIARRHEA VACCINE (DUKORAL®) DUKORAL® is an oral vaccine for the prevention of diarrhea caused by Vibrio cholerae and/or heat-labile toxin producing ETEC24, the leading cause of travelers’ diarrhea. DUKORAL® is authorized for use in the European Union and Australia to protect against cholera, and in Canada, Switzerland, New Zealand and Thailand to protect against cholera and ETEC. DUKORAL® sales increased by 302.6% to €10.2 million in the first quarter of 2023 compared to €2.5 million in the first quarter of 2022, also benefitting from the significant recovery in the private travel markets as well as price increases. THIRD-PARTY DISTRIBUTION Valneva distributes certain third-party vaccines in countries where it operates its own marketing and sales infrastructure. In the first quarter of 2023, Valneva’s third party product sales were €4.5 million compared to €5.6 million in the first quarter of 2022. First Quarter 2023 Financial Review (Unaudited, consolidated under IFRS) RevenuesValneva’s total revenues were €33.5 million in the first quarter of 2023 compared to €21.8 million in the first quarter of 2022, an increase of 53.4%.Valneva’s total product sales reached €32.1 million in the first quarter of 2023 compared to €16.2 million in the first quarter of 2022, an increase of 98.6%. This was driven by a continued recovery of travel vaccine sales. On a constant exchange rate (CER) basis, product sales increased by 101.0% in the first quarter of 2023 compared to the first quarter of 2022. No COVID-19 vaccine sales were recorded in the first quarter of 2023 while the previous year’s quarter included €3.8 million. IXIARO®/JESPECT® product sales were €17.4 million in the first quarter of 2023 compared to €4.2 million in the first quarter of 2022, an increase of 315.2% (314.5% at CER) with sales benefitting from the continuing recovery of travel markets and price increases. DUKORAL® sales were €10.2 million in the first quarter of 2023 compared to €2.5 million in the first quarter of 2022, an increase of 302.6% (317.3% at CER), also benefitting from the significant recovery in the private travel markets and price increases. Third Party product sales declined to €4.5 million in the first quarter of 2023 compared to €5.6 million in the first quarter of 2022, a decrease of 19.7%, which was mainly driven by supply constraints of products sold under the distribution agreement with Bavarian Nordic for the sales of Rabipur®/RabAvert® and Encepur®.Other revenues, including revenues from collaborations, licensing and services amounted to €1.4 million in the first quarter of 2023 compared to €5.7 million in the first quarter of 2022. The decline mainly resulted from declining customer services in the Clinical Trial Material (CTM) unit in Sweden and no further revenues recognized from the Pfizer Lyme VLA15 collaboration agreement. Operating Result and adjusted EBITDA Costs of goods and services sold (COGS) were €20.5 million in the first quarter of 2023. The gross margin on commercial product sales excluding COVID-19 sales was 48.4% compared to 68.5% in the first quarter of 2022. COGS of €7.2 million related to IXIARO® product sales yielded a product gross margin of 58.7%. COGS of €6.3 million related to DUKORAL® product sales yielded a product gross margin of 38.3%. Of the remaining COGS for the first quarter of 2023, €3.1 million were related to the Third-Party product distribution business. In the first quarter of 2022, overall COGS were €14.7 million, of which €9.6 million related to cost of goods and €5.1 million related to cost of services.Research and development expenses amounted to €14.1 million in the first quarter of 2023 compared to €20.7 million in the first quarter of 2022. This decrease was mainly driven by lower spend on Valneva’s COVID-19 vaccine VLA2001. Marketing and distribution expenses in the first quarter of 2023 amounted to €9.0 million compared to €2.0 million in the first quarter of 2022. Marketing and distribution expenses in the first quarter of 2023 notably included €3.4 million of expenses related to the launch preparation costs of the chikungunya vaccine candidate, VLA1553, compared to €1.2 million in the first quarter of 2022. In the first quarter of 2023, general and administrative expenses increased to €10.0 million from €5.8 million in the first quarter of 2022. COGS, research and development, marketing and distribution as well as general and administrative expenses benefited in the first quarter of 2022 from an accrual adjustment income of €11.7 million related to the favorable effect of the Company’s share price development on the employee share-based compensation programs. Other income, net of other expenses, increased to €3.5 million in the first quarter of 2023 from €2.1 million in the first quarter of 2022. This increase was mainly driven by recognizing grant income received from Scottish Enterprise into the income statement in the first quarter of 2023.Valneva recorded an operating loss of €16.6 million in the first quarter of 2023 compared to an operating loss of €18.4 million in the first quarter of 2022. Adjusted EBITDA loss in the first quarter of 2023 was €12.3 million compared to an Adjusted EBITDA loss of €13.3 million in the first quarter of 2022 (as explained further below). Net Result In the first quarter of 2023, Valneva generated a net loss of €18.1 million compared to a net loss of €26.0 million in the first quarter of 2022. Finance expense and foreign currency effects in the first quarter of 2023 resulted in a net finance expense of €1.7 million, compared to a net finance expense of €7.1 million in the first quarter of 2022. This was mainly a result of a foreign exchange gain amounting to €3.2 million in the first quarter of 2023, primarily driven by revaluation results of non-Euro denominated balance sheet positions, compared to a net foreign exchange loss of €2.4 million in the first quarter of 2022. Interest expenses net of interest income were €4.8 million in the first quarter of 2023 compared to €4.7 million in the first quarter of 2022. Cash Flow and Liquidity Net cash used in operating activities amounted to €24.3 million in the first quarter of 2023 compared to €26.9 million of cash used in operating activities in the first quarter of 2022. Cash outflows in the first quarter of 2023 and 2022 mainly resulted from the operating loss generated in both periods.Cash outflows from investing activities amounted to €3.6 million in the first quarter of 2023 compared to €9.4 million in the first quarter of 2022, both mainly related to construction activities at the Scottish production site and purchases of equipment.Net cash used in financing activities amounted to €3.8 million in the first quarter of 2023, which was mainly due to interest payments as well as payments of lease liabilities. Cash inflows in the first quarter of 2022 amounted to €1.0 million and was a result of proceeds from the issuance of new shares in relation to employee stock option and free share programs. Cash, cash equivalents and restricted cash amounted to €254.5 million as at March 31, 2023, compared to €289.4 million as at December 31, 2022. Non-IFRS Financial MeasuresManagement 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 common supplemental measure of performance used by investors and financial analysts. Management believes this measure provide additional analytical tools. Adjusted EBITDA is defined as earnings (loss) from continuing operations before interest expense, income taxes, depreciation and amortization. A reconciliation of Adjusted EBITDA to operating loss, which is the most directly comparable IFRS measure, is set forth below: € in million 3 months ending March 31 (unaudited results, consolidated per IFRS) 2023 2022 Net Income (18.1) (26.0) Add: Income tax expense (0.1) 0.5 Total Finance income (0.3) (0.0) Total Finance expense 5.1 4.7 Foreign exchange gain/(loss) – net (3.2) 2.4 Result from investments in associates - - Amortization 1.6 1.6 Depreciation 2.6 3.6 Impairment of Tangible Assets - - Adjusted EBITDA (12.3) (13.3) About Valneva SEWe are a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases. We take a highly specialized and targeted approach to vaccine development by focusing on vaccine solutions addressing unmet medical needs to ensure we can make a difference to peoples’ lives. We apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, and our established vaccine development capabilities, to develop vaccines against diseases which are not yet vaccine-preventable, or for which there are limited effective treatment options. Today, we are leveraging our expertise and capabilities to rapidly advance a broad range of vaccines into and through the clinic, including candidates against the chikungunya virus and Lyme disease. Valneva Investor and Media ContactsLaetitia Bachelot-FontaineVP, Global Communications and European Investor RelationsM +33 (0)6 4516 7099investors@valneva.com Joshua Drumm, Ph.D.VP, Global Investor Relations M +001 917 815 4520joshua.drumm@valneva.com Forward-Looking StatementsThis press release contains certain forward-looking statements relating to the business of Valneva, including with respect to expected total revenues and product sales for full fiscal year 2023 and the expected timing for submissions to and responses by regulatory authorities. 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 indicative of future results. 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 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 involved in the development and manufacture of vaccines, unexpected clinical trial results or delays, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, the ability to obtain or maintain patent or other proprietary intellectual property protection, the cancellation of existing contracts, and the impact of the COVID-19 pandemic, the occurrence of any of which could substantially harm Valneva’s business, financial condition, prospects and results of operations. 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 this press release as of the date hereof 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. Annex 1. UNAUDITED INTERIM CONSOLIDATED STATEMENTS OF INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) € in thousand Three months ended March 31, (except per share amounts) 2023 2022 Product sales 32,100 16,162 Other revenues 1,408 5,686 Revenues 33,508 21,847 Cost of goods and services (20,480) (13,860) Research and development expenses (14,065) (20,689) Marketing and distribution expenses (8,986) (2,034) General and administrative expenses (10,038) (5,770) Other income and expenses, net 3,488 2,084 OPERATING LOSS (16,574) (18,422) Finance income 253 13 Finance expenses (5,096) (4,718) Foreign exchange gain/(loss), net 3,170 (2,412) LOSS BEFORE INCOME TAX (18,247) (25,539) Income tax income/(expense) 120 (502) LOSS FOR THE PERIOD (18,127) (26,041) Losses per share for profit/loss for the period attributable to the equity holders of the Company, expressed in € per share - basic (0.13) (0.24) - diluted (0.13) (0.24) 1.2 Unaudited Interim Condensed Consolidated Statement of Comprehensive Income (Loss) € in thousand Three months ended March 31, 2023 2022 Loss for the period (18,127) (26,041) Other comprehensive income/(loss) Items that may be reclassified to profit or loss Currency translation differences 1,628 (244) Other comprehensive income/(loss) for the period, net of tax 1,628 (244) TOTAL COMPREHENSIVE LOSS FOR THE PERIOD ATTRIBUTABLE TO THE OWNERS OF THE COMPANY (16,500) (26,285) 2. UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS € in thousand March 31, December 31, 2023 2022 ASSETS Non-current assets 200,671 196,685 Intangible assets 27,896 28,711 Right of use assets 43,640 41,603 Property, plant and equipment 114,399 112,435 Deferred tax assets 6,146 5,637 Other non-current assets 8,590 8,299 Current assets 389,329 424,660 Inventories 38,999 35,104 Trade receivables 27,018 23,912 Other current assets 66,693 74,079 Cash and cash equivalents 254,485 289,430 Assets classified as held for sale 2,134 2,134 TOTAL ASSETS 590,000 621,344 EQUITY Capital and reserves attributable to the Company’s equity holders 204,783 219,797 Share capital 20,752 20,755 Share premium 594,043 594,043 Other reserves 58,369 55,252 Retained earnings/(Accumulated deficit) (450,253) (306,974) Loss for the period (18,127) (143,279) LIABILITIES Non-current liabilities 121,958 124,156 Borrowings 83,228 87,227 Lease liabilities 29,556 28,163 Refund liabilities 6,684 6,635 Provisions 1,326 1,320 Deferred tax liabilities 1,057 694 Other liabilities 107 116 Current liabilities 263,260 277,392 Borrowings 14,157 11,580 Trade payables and accruals 33,520 41,491 Income tax liability 420 532 Tax and Employee-related liabilities 15,875 15,738 Lease liabilities 25,787 25,411 Contract liabilities 9,159 9,411 Refund liabilities 135,294 136,450 Provisions 24,037 31,257 Other liabilities 5,010 5,523 TOTAL LIABILITIES 385,217 401,547 TOTAL EQUITY AND LIABILITIES 590,000 621,344 3. UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS € in thousand Three months ended March 31, 2023 2022 Cash flows from operating activities Loss for the period (18,127) (26,041) Adjustments for non-cash transactions 8,438 (6,922) Changes in non-current operating assets and liabilities (269) (4,763) Changes in working capital (13,935) 11,193 Cash generated from/(used in) operations (23,893) (26,533) Income tax paid (433) (318) Net cash generated from/(used in) operating activities (24,326) (26,851) Cash flows from investing activities Purchases of property, plant and equipment, net of proceeds from sale (3,814) (9,385) Purchases of intangible assets, net of proceeds from sale — (76) Interest received 253 13 Net cash used in investing activities (3,561) (9,447) Cash flows from financing activities Proceeds from issuance of common stock, net of costs of equity transactions (194) 3,726 Payment of lease liabilities (933) (835) Interest paid (2,689) (1,909) Net cash generated from/(used in) financing activities (3,816) 982 Net change in cash and cash equivalents (31,703) (35,316) Cash and cash equivalents at beginning of the period 286,532 346,642 Exchange gains/(losses) on cash (344) (107) Restricted cash — 45 Cash and cash equivalents at end of the period 254,485 311,264 1 For additional information on Adjusted EBITDA, please refer to the “Non-IFRS Financial Measures” section at the end of the PR2 https://www-who-int.libproxy1.nus.edu.sg/news-room/fact-sheets/detail/chikungunya3https://www.paho.org/en/documents/epidemiological-alert-chikungunya-increase-region-americas4 FDA Accepts Valneva’s Chikungunya Vaccine License Application for Priority Review - Valneva5 Valneva Initiates Rolling Submission of FDA Biologics License Application for its Single-Shot Chikungunya Vaccine Candidate - Valneva6 This statement refers to Valneva and its predecessor Intercell7 Tropical Disease Priority Review Voucher Program | FDA8 Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate9 Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate10 Valneva Reports Positive 12-Month Antibody Persistence Data for Single-Shot Chikungunya Vaccine Candidate - Valneva11 Valneva Announces Initiation of Adolescent Phase 3 Trial for its Single-Shot Chikungunya Vaccine Candidate – Valneva12 Valneva Completes Enrollment for Adolescent Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate - Valneva13 Valneva and Pfizer Report Six-Month Antibody Persistence Data in Children and Adults for Lyme Disease Vaccine Candidate - Valneva14Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15 - Valneva15 Valneva and Pfizer Report Further Positive Phase 2 Results, Including Booster Response, for Lyme Disease Vaccine Candidate - Valneva16 Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15 - Valneva17 https://www-cdc-gov.libproxy1.nus.edu.sg/epstein-barr/index.html#:~:text=EBV%20can%20cause%20infectious%20mononucleosis,common%20among%20teens%20and%20adults.18 https://www.cancer.org/healthy/cancer-causes/infectious-agents/infections-that-can-lead-to-cancer/viruses.html#:~:text=EBV%20infection%20increases%20a%20person's,some%20cases%20of%20stomach%20cancer.19 https://www-nih-gov.libproxy1.nus.edu.sg/news-events/nih-research-matters/study-suggests-epstein-barr-virus-may-cause-multiple-sclerosis#:~:text=Infection%20with%20Epstein%2DBarr%20virus,could%20help%20prevent%20multiple%20sclerosis20 https://www-cdc-gov.libproxy1.nus.edu.sg/ncird/human-metapneumovirus.html21 Macri A, Crane JS. Parvoviruses. 2022 May 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan–. PMID: 29489222.22https://www-cdc-gov.libproxy1.nus.edu.sg/campylobacter/faq.html#:~:text=Campylobacter%20infection%2C%20or%20campylobacteriosis%2C%20is,year%20for%20every%20100%2C000%20people.23 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.24 Enterotoxigenic Escherichia coli (ETEC) is a type of Escherichia coli and one of the leading bacterial causes of diarrhea in the developing world, as well as the most common cause of travelers’ diarrhea. Attachment 2023_05_04_Q1_Results_PR_EN_Final