Infectious Mononucleosis

Announces next-generation COVID-19 vaccine candidate as fourth respiratory vaccine to successfully meet its Phase 3 endpoints Expects two more Phase 3 readouts in 2024, including combination vaccine against flu and COVID-19, and vaccine against CMV Announces positive clinical trial data from three new vaccines against viruses that cause significant burden (Epstein-Barr virus, Varicella-Zoster virus, norovirus) and advances programs toward Phase 3 development Anticipates U.S. launch of vaccine against RSV following FDA approval and ACIP recommendation in 2024 Announces development and commercialization funding agreement with Blackstone Life Sciences for up to $750 million to advance flu program CAMBRIDGE, MA / ACCESSWIRE / March 27, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced at its fifth Vaccines Day event clinical and program updates demonstrating advancement and acceleration of its mRNA pipeline. The updates include data readouts in the Company's respiratory and latent and other vaccine portfolios, as well as commercial, manufacturing and financial announcements for its vaccines business. "Our mRNA platform continues a remarkable track record across our broad vaccine portfolio. Today, we are excited to share that four vaccines in our pipeline have achieved successful clinical readouts across our respiratory, latent and other virus franchises," said Stéphane Bancel, Chief Executive Officer of Moderna. "With five vaccines in Phase 3, and three more moving toward Phase 3, we have built a very large and diverse portfolio addressing significant unmet medical needs. We are focused on execution to further build momentum across our pipeline and business, and to deliver for patients who are impacted by these infectious diseases." Portfolio Overview The vaccine portfolio seeks to address infectious diseases that cause considerable health burdens and includes 28 vaccines addressing respiratory, latent and other pathogens. Latent and Other Vaccine Portfolio Moderna is advancing five vaccine candidates against viruses that cause latent infections, all of which are in clinical trials. When latent, a virus is present in the body but exists in a resting state, typically without causing any noticeable symptoms. Latent viruses can reactivate and cause clinical symptoms as a person ages, during times of stress or when immunity is compromised. The capacity for latency is a defining feature of members of the Herpesviridae family, including cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus (HSV) and Varicella-Zoster virus (VZV). Cytomegalovirus (CMV) CMV is the most common infectious cause of birth defects in the U.S. and is responsible for several billion dollars in annual healthcare costs. One in 200 babies in the U.S. are born with a congenital CMV infection, and of those affected, one in five will have severe, life-altering health problems. Possible short- and long-term sequelae of CMV infection include microcephaly, chorioretinitis, seizures, sensorineural hearing loss, cognitive impairment and cerebral palsy. There is currently no approved vaccine to prevent congenital CMV. CMVictory is a pivotal Phase 3 trial evaluating mRNA-1647 against primary CMV infection in women 16 to 40 years of age. The trial is a randomized, observer-blind, placebo-controlled study designed to evaluate the efficacy, safety and immunogenicity of mRNA-1647. The trial is fully enrolled with approximately 7,300 participants from 290 clinical sites globally. To date, 50 primary infection cases have accrued and are undergoing confirmation. The first interim analysis for the evaluation of vaccine efficacy, which will be triggered when both 81 confirmed per-protocol cases and 12 median months of safety follow-up have occurred, is expected as early as the end of 2024. Moderna's CMV vaccine candidate mRNA-1647 has advanced to indication expansion studies in adolescents 9 to 15 years of age and adult transplant patients, both of which have begun enrollment. Epstein-Barr virus (EBV) EBV is a major cause of infectious mononucleosis (IM) in the U.S., accounting for more than 90% of IM cases annually. Importantly, EBV and IM are associated with a higher lifetime risk of more serious sequelae including certain cancers such as gastric carcinoma, nasopharyngeal carcinoma and multiple types of lymphoma. The lifetime risk of developing multiple sclerosis (MS) is increased by 32-fold after EBV infection. There is currently no approved vaccine to prevent EBV. Moderna's EBV vaccine candidates are designed to tackle multiple EBV-associated conditions, including prevention of IM (mRNA-1189) and MS and post-transplant lymphoproliferative disorder, a subcategory of lymphoma in solid organ transplant patients (mRNA-1195). The Phase 1 trial for mRNA-1189 was designed to test the safety, reactogenicity and immunogenicity of four different dose levels in participants 12 to 30 years of age in the U.S. The randomized, observer-blind, placebo-controlled study showed mRNA-1189 was immunogenic and generally well tolerated across all dose levels. The Company is advancing mRNA-1189 toward a pivotal Phase 3 trial. The Phase 1 trial for mRNA-1195 was designed to test the safety, reactogenicity and immunogenicity of two drug products at four different dose levels in healthy EBV seropositive participants 18 to 55 years of age in the U.S. The randomized, observer-blind, placebo-controlled study is fully enrolled. Herpes simplex virus (HSV) Herpes simplex virus type 2 (HSV-2) infects approximately 13% of adults globally and is the primary cause of genital herpes. There are an estimated four billion people globally infected with HSV, of which 491 million cases are HSV-2. Recurrent genital herpes causes a reduction in quality of life, which antivirals (current standard of care) only partially restore. Moderna expects that if an HSV vaccine candidate could deliver similar efficacy as a suppressive antiviral treatment, compliance with recommended therapy and associated quality of life would improve. There is currently no approved vaccine to treat HSV-2. The first in human, fully enrolled Phase 1/2 trial of mRNA-1608 is designed to test safety and immunogenicity and to establish a proof-of-concept of clinical benefit in adults 18 to 55 years of age with recurrent HSV-2 genital herpes. The randomized 1:1:1:1, observer-blind, controlled study is fully enrolled with 300 participants in the U.S. Varicella-Zoster virus (VZV) Herpes zoster, also known as shingles, is caused by reactivation of latent VZV, the same virus that causes chickenpox. Declining immunity in older adults decreases immunity against VZV, allowing reactivation of the virus from latently infected neurons, causing painful and itchy lesions. Herpes Zoster occurs in one out of three adults in the U.S. in their lifetime and the incidence increases at 50 years of age. There is potential to reach a growing and underserved patient population. Moderna's VZV vaccine candidate mRNA-1468 has initial data available from a Phase 1/2 trial, which was designed to test safety and immunogenicity in healthy adults 50 years of age and older in the U.S. The randomized 1:1:1:1:1, observer-blind, active-controlled study of mRNA-1468 elicited strong antigen-specific T cell responses at one month after the second dose and was generally well tolerated. Results of the first interim analysis support the further clinical development of mRNA-1468 for the prevention of shingles. Additional results from the ongoing Phase 1/2 study will be available later this year, including persistence data. The Company is planning for a pivotal Phase 3 trial. Norovirus Enteric viruses, including norovirus, are a leading cause of diarrheal diseases, resulting in significant morbidity and mortality worldwide, particularly among young children and older adults. Norovirus is highly contagious and a leading cause of diarrheal disease globally, associated with 18% of all acute gastroenteritis (AGE), resulting in approximately 200,000 deaths per year and substantial healthcare costs. Given the wide diversity of norovirus genotypes, a broadly effective norovirus vaccine will require a multivalent vaccine design. There is currently no approved vaccine to prevent norovirus. The randomized, observer-blind, placebo-controlled Phase 1 trial was designed to evaluate the safety, reactogenicity and immunogenicity of trivalent (mRNA-1403) and pentavalent (mRNA-1405) norovirus vaccine candidates in 664 participants 18 to 49 years of age and 60 to 80 years of age in the U.S. An interim analysis showed that a single dose of mRNA-1403 elicited a robust immune response across all dose levels evaluated with a clinically acceptable reactogenicity and safety profile. The Company is advancing mRNA-1403 toward a pivotal Phase 3 trial. Respiratory Vaccine Portfolio Moderna's approach to ease the global burden of respiratory infections includes vaccine candidates against major causative pathogens, including SARS-CoV-2, respiratory syncytial virus (RSV) and influenza virus. Respiratory infections are a top cause of death in the U.S. and are particularly harmful to the young, immunocompromised, and older adults who experience more severe illness, greater incidence of hospitalization, and greater mortality than younger adults. Moderna's respiratory pipeline includes Phase 3 trials for investigational vaccines including a next-generation COVID-19 vaccine, an RSV vaccine, a flu vaccine, and a flu and COVID-19 combination vaccine. The pipeline includes three additional flu vaccine candidates with expanded antigen coverage as well as combination vaccine programs. COVID-19 Moderna continues to address the needs of the endemic COVID-19 market by focusing on public health efforts to increase vaccination coverage rates to reduce the substantial burden of COVID-19 as well as by advancing next-generation vaccines. The Company's mRNA platform can produce variant-matched vaccines on an accelerated time horizon, consistent with recent U.S. Food and Drug Administration (FDA) comments on the timing of potential strain selection for the fall booster season. A recent announcement of positive interim results from the NEXTCove Phase 3 trial showed that mRNA-1283 elicited a higher immune response against both the Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2 compared to mRNA-1273.222, Moderna's licensed COVID-19 vaccine. mRNA-1283 is designed to be refrigerator-stable and paves the way for a combination vaccine against influenza and COVID-19, mRNA-1083, enhancing the Company's overall respiratory portfolio. This is Moderna's fourth infectious disease vaccine program with Phase 3 data. Respiratory Syncytial Virus (RSV) RSV is the leading cause of respiratory illness in young children, and older adults are at increased risk relative to younger adults for severe outcomes. In addition to acute mortality and morbidity, RSV infection is associated with long-term sequelae such as asthma and impaired lung function in pediatric populations, and exacerbation of chronic obstructive pulmonary disease in older adults. Annually, there are approximately two million medically attended RSV infections and 58,000 to 80,000 hospitalizations in children younger than five years old in the U.S. In the U.S., each year there are up to 160,000 hospitalizations and 10,000 deaths in adults 65 years and older due to RSV. Across high-income countries in 2019, RSV caused an estimated 5.2 million cases, 470,000 hospitalizations and 33,000 in-hospital deaths in adults 60 years and older. mRNA-1345 Moderna's RSV vaccine candidate, mRNA-1345, is in an ongoing Phase 2/3, randomized, observer-blind, placebo-controlled case-driven trial (ConquerRSV) in adults over 60 years of age. In this study, approximately 37,000 participants from 22 countries were randomized 1:1 to receive one dose of mRNA-1345 or placebo. Based on positive data from the ConquerRSV trial, Moderna has filed for regulatory approvals for mRNA-1345 for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults over 60 years of age. The trial met both its primary efficacy endpoints, with a vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-LRTD as defined by two or more symptoms, and a VE of 82.4% (96.36% CI: 34.8%, 95.3%; p=0.0078) against RSV-LRTD defined by three or more symptoms. These data were published in the New England Journal of Medicine in December 2023. A subsequent analysis from the ConquerRSV study with a longer median follow-up duration of 8.6 months (versus 3.7 months in the primary analysis), with a range of 15 days to 530 days, and including subjects from the Northern and Southern Hemispheres was recently presented at the RSVVW'24 conference. In this supplemental analysis, mRNA-1345 maintained durable efficacy, with sustained VE of 63.3% (95.88% CI: 48.7%, 73.7%) against RSV-LRTD including two or more symptoms. VE was 74.6% (95% CI: 50.7%, 86.9%) against RSV-LRTD with ≥2 symptoms, including shortness of breath and 63.0% (95% CI: 37.3%, 78.2%) against RSV-LRTD including three of more symptoms. The stringent statistical criterion of the study, a lower bound on the 95% CI of >20%, continued to be met for both endpoints. mRNA-1345 has been granted Breakthrough Therapy designation by the FDA for the prevention of RSV-LRTD in adults over 60 years of age. The Company is awaiting regulatory approvals and the U.S. ACIP recommendation in 2024. Indication expansion studies for mRNA-1345 mRNA-1345 has the potential to protect all vulnerable populations from RSV. Moderna has initiated multiple Phase 3 expansion studies in adults over 50 years of age to evaluate co-administration and revaccination. Additional trials (Phase 1 - Phase 3) have been initiated for high-risk adults, as well as maternal and pediatric populations. Interim data from these studies could be available as early as 2024. Influenza (Flu) Worldwide, influenza leads to 3-5 million severe cases of flu and 290,000-650,000 flu-related respiratory deaths annually. Two main types of influenza viruses (A and B) cause seasonal flu epidemics, and the influenza A viruses lead to most flu-related hospitalization in older adults. The Company has several seasonal influenza vaccine candidates in clinical development. Moderna's seasonal flu vaccine, mRNA-1010, demonstrated consistently acceptable safety and tolerability across three Phase 3 trials. In the most recent Phase 3 trial (P303), which was designed to test the immunogenicity and safety of an optimized vaccine composition, mRNA-1010 met all immunogenicity primary endpoints, demonstrating higher antibody titers compared to a currently licensed standard-dose flu vaccine. In an older adult extension study of P303, mRNA-1010 is being studied against high dose Fluzone HD®; the trial is fully enrolled. The Company is in ongoing discussions with regulators and intends to 2024. Combination Respiratory Vaccines Moderna's combination vaccine candidates cover respiratory viruses associated with the largest disease burden in the category. The Phase 3 combination study of the Company's investigational combination vaccine against flu and COVID-19 (mRNA-1083) for adults aged 50 years and older is fully enrolled and data are expected in 2024. mRNA-1083 was granted Fast Track designation by the FDA in May 2023. Commercial Updates Respiratory viruses in addition to latent and other viruses represent large unmet or underserved medical needs, and the human and economic costs from these infectious diseases highlight the need for effective vaccines. To help address this need, Moderna expects multiple vaccine product launches in the next few years, each with significant addressable markets. The 2024 global endemic COVID-19 vaccine market alone is estimated by Moderna to be approximately $10 billion. COVID-19 continues to show a high burden of disease, and while COVID-19 hospitalizations remain high relative to RSV and flu, the risks of Long COVID are also becoming better understood. Moderna is focused on improving education and awareness to increase vaccination rates as Long COVID data suggests even traditionally low-risk groups should be vaccinated. Moderna is also working with health authorities to align the timing of COVID-19 and flu vaccine launches to help improve public health. For RSV, Moderna estimates the peak annual market to be approximately $10 billion. The Company expects a strong RSV vaccine launch into a large market in 2024. As the only mRNA investigational vaccine with positive Phase 3 data, Moderna's RSV vaccine candidate has a strong pro consistently strong efficacy across vulnerable and older populations, a well-established safety and tolerability profile, and ease of administration with a ready-to-use, pre-filled syringe formulation, which could relieve some of the burden that falls on pharmacies during the fall vaccination season. An interim analysis from an ongoing time and motion study evaluating differences in preparation time between a pre-filled syringe (PFS) presentation and vaccines that require reconstitution showed that a PFS presentation could relieve some of the burden that falls on pharmacies during the fall vaccination season. Results from this study suggest that pharmacies may be capable of preparing up to four times as many doses of PFS in an hour compared to vaccines requiring reconstitution. Moderna estimates flu vaccines represent an approximately $7 billion market in 2024. The market is expected to grow with the rise of more effective vaccines and there is an opportunity to expand the market with next-generation premium flu vaccines as well as combination respiratory vaccines, adding increased value to the health ecosystem. CMV is expected to be a $2-5 billion annual market. With no vaccine currently on the market and a potential vaccine launch in 2026, Moderna could be the first CMV vaccine in multi-billion-dollar latent vaccine market. In addition, EBV has the potential to address and reduce the burden and cost of EBV infection in multiple populations, while VZV provides the opportunity to enter a large and growing market, which could be $5-6 billion annually. The market for norovirus vaccines is similar to that of rotavirus in pediatrics with opportunity to expand into the adult population, and represents a $3-6 billion annual market. Moderna's vaccine portfolio targets large addressable markets, with an estimated total addressable market (TAM) of $52 billon for Moderna infectious disease vaccines, which includes a respiratory vaccines TAM of more than $27 billion and a latent and other vaccines TAM of more than $25 billion. Manufacturing The Company's manufacturing innovation supports expanding commercialization of a diverse pipeline through efficiency and productivity gains. Its mRNA manufacturing platform enables benefits such as quality, speed, scale and cost efficiency across a footprint that broadly includes the manufacture of plasmid, mRNA, lipid nanoparticles, as well as fill/finish and quality control capabilities. As the Company continues to build its footprint for the future, it is developing an agile global manufacturing network to meet commercial demand and support its growing pipeline. Pre-clinical through commercial manufacturing occurs at the Moderna Technology Center in Norwood, Massachusetts, which remains central to the Company's network. New facilities being constructed in Australia, Canada and the UK are expected to come online in 2025, and drug product capacity is achieved through a flexible contract manufacturing network. Additionally, the Company has purchased and started build-out of a manufacturing site in Marlborough, Massachusetts, to enable commercial scale of its individualized neoantigen therapy program. By continuing to pioneer new technologies, including advanced robotics, applying AI and other digital solutions, and driving network and capital efficiency, Moderna's manufacturing network is expected to also drive more predictable cost of sales. Research and Development Investment Strategy Today's updates provide further evidence that Moderna's mRNA technology platform is working, and with a rate of success higher than industry standard. Looking ahead, research and development will continue to be the Company's top capital allocation priority. As Moderna looks to create value through the research and development strategy for its vaccine portfolio, it is taking three prioritization parameters into consideration: pipeline advancement, revenue diversification and risk reduction. As part of its strategy, the funding options Moderna considers are self-funding, project financing and partnerships. Moderna recently entered into a development and commercialization funding agreement with Blackstone Life Sciences to advance the Company's flu program. As part of the agreement, Blackstone will fund up to $750 million with a return based on cumulative commercial milestones and low-single digit royalties. Moderna expects to recognize the funding as a reduction in research and development expenses and will retain full rights and control of the Company's flu program. This funding does not result in any change to Moderna's 2024 research and development framework of approximately $4.5 billion. About Moderna Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. INDICATION (U.S.) SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. IMPORTANT SAFETY INFORMATION Do not administer to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine. Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine. Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age. Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting. Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the vaccine. The vaccine may not protect all vaccine recipients. Adverse reactions reported in clinical trials following administration of the vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site, and rash. The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at or by calling 1-800-822-7967. Please see the SPIKEVAX Full Prescribing Information. For information regarding authorized emergency uses of the Moderna COVID-19 Vaccine, please see the EUA Fact Sheet. Spikevax® is a registered trademark of Moderna. Fluzone® is a registered trademark of Sanofi Pasteur. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the advancement of Moderna's programs under clinical development; the timing for anticipated approvals of vaccine candidates; the efficacy, safety and tolerability of vaccine candidates; the total addressable markets for programs under development; the efficiencies and advantages of Moderna's mRNA platform; future capital allocation and financing efforts; and anticipated spending for R&D in 2024. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at . Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this presentation in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. ​ ### Moderna Contacts Media: Chris Ridley Head, Global Media Relations +1 617-800-3651 Chris.Ridley@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 Lavina.Talukdar@modernatx.com SOURCE: Moderna, Inc. View the original press release on accesswire.com

Total revenues of €153.7 million, including product sales of €144.6 million Product sales surpassed pre-pandemic (2019) sales by 12% and 2022 sales by 26% Excluding COVID-19 vaccine sales, product sales grew by 63% compared to 2022 Cash position of €126.1 million at year-end 2023 enhanced by €95 million from sale of Priority Review Voucher (PRV)1 Extended the interest-only period of existing debt financing agreement to January 2026 significantly extending cash runway2 Operational business considered sufficiently funded (excluding debt repayment) until commercial revenues from Lyme program enable sustained profitability Excellent progress across R&D pipeline Approval of single-shot chikungunya vaccine IXCHIQ® in the United States (U.S.) The world’s first and only vaccine to address this significant unmet medical need U.S. CDC recently adopted ACIP recommendations3 Regulatory reviews ongoing in Europe, Canada and Brazil Completion of recruitment for Lyme disease Phase 3 study conducted in collaboration with Pfizer All execution milestones on track Advancing second-generation ZIKA vaccine candidate into Phase 1 clinical trial Addressing a re-emerging medical need Updated FY 2024 guidance Valneva raises its 2024 product sales4 guidance to between €160 million and €180 million due to an improved outlook regarding the IXIARO® supply constraints that were anticipated in February 2024. As such, 2024 total revenues are now expected to reach between €170 million and €190 million compared to €153.7 million in 2023, driven by continued sales growth of the Company’s proprietary travel vaccines and the launch-year sales of IXCHIQ®. Sales are expected to grow this year despite an estimated 20-30% reduction in third-party sales as a result of anticipated supply constraints. In 2024, the Company anticipates lower R&D expenses than previously communicated, narrowing guidance to €60 million to €75 million, based on additional visibility for its chikungunya- and Zika- related expenses. Additionally, Valneva expects non-dilutive contributions from institutions for R&D costs in connection with its ongoing chikungunya activities and the product tech transfers to Valneva’s brand-new state-of the art facility (“Almeida”) in Scotland. Other income is now expected between €100 million and €110 million in 2024, reflecting €95 million in proceeds from the PRV sale in early 2024. Valneva anticipates a significantly lower cash burn this year than in 2023 and expects its commercial business to be cash-flow positive and contribute significantly to funding the Company’s R&D from 2025. Valneva’s cost contributions for the Lyme disease Phase 3 study are expected to be completed in the first half of 2024. All remaining payments to Pfizer are reflected in current refund liability at December 31, 2023, and will not impact the Profit & Loss statement in 2024. The Company has re-negotiated the terms of its loan agreement with Deerfield and OrbiMed5 and will now start reimbursing the first $100 million tranche in January 2026 instead of July 2024. The loan interest rate remains unchanged and this portion of the loan will still mature in the first quarter of 2027. Mid-term outlook Product sales In the mid-term, Valneva expects continued sales growth for its travel vaccines IXIARO® and DUKORAL®, and with the current launch of IXCHIQ®, the Company anticipates annual product sales to approximately double by the end of 2026. This will be driven by IXIARO®, for which continued double-digit annual growth is expected for at least the next three years, and by ramping IXCHIQ® sales, which are expected to exceed €100 million in year three after initial launch, subject to anticipated regulatory approvals and even assuming potential competitive product entry. There may also be upside from potential IXCHIQ® stockpiling opportunities. Regulatory reviews are ongoing in Europe, Canada and Brazil, and decisions for these submissions are expected in 2024. The Company currently estimates that the travel market opportunity for chikungunya vaccines could be valued between €300 million to €400 million based on the number of travelers to endemic regions and their anticipated adoption of the vaccine. Additionally, considering the high unmet medical need that chikungunya represents in Low- and Middle-Income Countries (LMICs), Valneva expects strong adoption of its chikungunya vaccine in these countries. The third-party product business supported Valneva’s revenues as a complement to its existing travel vaccine portfolio, especially during the COVID-19 pandemic. However, 2023 third-party sales of more than €35 million yielded only 36% gross margin, diluting Valneva’s overall margins, and the Company has therefore decided to focus resources on direct sales of its proprietary products. Valneva expects that third-party sales will gradually wind down to less than 5% of product sales by 2026/2027, considering the anticipated end to its collaboration with Bavarian Nordic by the end of 2025. This is expected to bring the gross margin back to pre-COVID levels or better, with additional margin improvements expected from the cost-efficient manufacturing process of IXCHIQ® and scaling effects from leveraging the Company’s new manufacturing facilities in Livingston (Scotland) and Solna (Sweden). R&D Valneva will continue leveraging its proven capabilities to develop differentiated first-, best- or only-in-class vaccine solutions in areas of high unmet medical need. As in previous years, the Company will focus on advancing a limited number of promising product candidates with the aim to have an additional clinical program entering Phase 3 upon completion of the Phase 3 program for Lyme. Valneva may reach its pipeline development objective organically and/or via strategic transactions. Over the next three years, the Company expects approximately 40% of its R&D expenses to be linked to chikungunya development activities, including ongoing and anticipated clinical studies. These chikungunya expenses are expected to be supported at a sizable level by non-dilutive contributions from several institutions. Cash management In the mid-term, Valneva will continue focusing on stringent cost management with a particular focus on marketing and distribution as well as general and administrative costs. In parallel, IXCHIQ® sales ramp-up and anticipated gross margin improvements will further reduce the Company’s cash burn. The Company reduced its loss by more than €40 million in 2023 and expects to further reduce it in the coming years, anticipating that Valneva may achieve sustained profitability with potential commercial revenues from a successful development, approval and launch of its Lyme disease vaccine candidate partnered with Pfizer. With the eighteen-month extension of the interest-only period of its Deerfield and OrbiMed loan6, and based on 2023 year-end cash as augmented by the proceeds from the PRV sale, Valneva believes that it is sufficiently financed for its operational business, excluding debt repayment, until potential commercial revenues from its Lyme program enable the Company to operate in a sustained profitable way. Financial Information (Audited 2023 results, consolidated per IFRS) € in million 12 months ending December 31 2023 2022 Total revenues 153.7 361.3 Product sales 144.6 114.8 Net profit/(loss) (101.4) (143.3) Adjusted EBITDA (loss) (65.2) (69.2) Cash 126.1 289.4 Saint-Herblain (France), March 20, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today reported its consolidated financial results for the year ending December 31, 2023 and provided several key corporate updates. Valneva will provide a live webcast of its full-year 2023 results conference call beginning at 3 p.m. CET/10 a.m. EDT today. This webcast will also be available on the Company’s website. Please refer to this link: Peter Bühler, Valneva’s Chief Financial Officer, commented, “In 2023, Valneva successfully executed on key strategic objectives despite a difficult economic environment. Our chikungunya vaccine IXCHIQ® became the world’s first licensed chikungunya vaccine available to address this significant unmet medical need and we also managed to surpass our pre-pandemic product sales. Our objective for 2024 is to continue capitalizing on the travel industry recovery to generate further commercial growth and successfully launch our chikungunya vaccine IXCHIQ®. With the recent successful sale of our PRV, and extension of our loan repayment, we have entered 2024 in a solid financial position to support our near- and mid-term commercial and R&D objectives.” Commercial Portfolio Valneva’s commercial portfolio is composed of three travel vaccines, IXIARO®/JESPECT®, DUKORAL® and IXCHIQ®. The Company also distributes certain third-party products in countries where it operates its own marketing and sales infrastructure. JAPANESE ENCEPHALITIS VACCINE IXIARO®/JESPECT® IXIARO®, or JESPECT® in Australia and New Zealand, is an inactivated Vero cell culture-derived Japanese encephalitis and is the only Japanese encephalitis vaccine currently approved for use 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, and is a required vaccine for U.S. military personnel who are deployed to areas of risk for Japanese encephalitis. The virus is spread by mosquitos and is the most important cause of viral encephalitis in Asia and the Western Pacific. In 2023, IXIARO®/JESPECT® sales increased 78% to €73.5 million compared to €41.3 million in 2022, primarily benefiting from the continued travel market recovery after the COVID-19 pandemic, and price increases. At the end of September 2023, Valneva also signed a new one-year contract with the U.S. Department of Defense (DoD) worth a minimum of $32 million for the supply of IXIARO®. CHOLERA / ETEC7-DIARRHEA VACCINE DUKORAL® DUKORAL® is an oral vaccine for the prevention of diarrhea caused by Vibrio cholerae and/or heat-labile toxin producing ETEC8, 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. In 2023, DUKORAL® sales increased 72% to €29.8 million compared to €17.3 million in 2022, of which Canada represented €17.5 million of global sales due to the strong overlap between Canadian travelers to regions of high ETEC prevalence and the vaccine’s approved indication. Similar to IXIARO®, DUKORAL® benefitted from the significant recovery in the private travel markets. CHIKUNGUNYA VACCINE IXCHIQ® IXCHIQ® is a single-dose, live-attenuated vaccine against the chikungunya virus (CHIKV), which in November 2023 was approved in the U.S. by the Food and Drug Administration (FDA) for the prevention of disease caused by CHIKV in individuals 18 years of age and older who are at increased risk of exposure to the mosquito-borne CHIKV. With this approval, IXCHIQ® became the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. At the end of February 2024, the U.S. Advisory Committee on Immunization Practices (ACIP), which develops recommendations on how to use vaccines in the U.S., recommended IXCHIQ® for persons aged 18 years and above traveling to a country or territory where a chikungunya outbreak is occurring. Additionally, IXCHIQ® may be considered for persons traveling to a country or territory without an outbreak but with evidence of CHIKV transmission within the last five years, who are aged 65 years and above, and likely to have at least moderate exposure to mosquitos (at least two weeks, cumulatively) or who are traveling for a longer duration (six months or more, cumulatively). ACIP also recommended chikungunya vaccination for laboratory workers with potential for exposure to CHIKV. The ACIP recommendations were recently adopted by the Centers for Disease Control and Prevention9. Valneva’s commercial team is currently launching the vaccine in the U.S. The single-shot vaccine is also under regulatory review in Canada, Brazil and Europe, where it was granted accelerated assessment by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP). Decisions for these submissions are expected in 2024. IXCHIQ®’s final pivotal Phase 3 data were published in The Lancet, the world’s leading peer-reviewed medical journal, in June 202310. The article provides a detailed analysis of the Phase 3 results showing that VLA1553 demonstrated a very high seroresponse rate of 98.9% in participants 28 days after receiving the single administration compared to the 70% threshold (for non-acceptance) agreed with the FDA. Valneva is working on the preparation of two Phase 4 post-marketing effectiveness studies, required as part of the FDA’s approval under the accelerated pathway. The Company expects to launch these studies in 2025. Earlier clinical data, published in the Lancet Infectious Diseases, showed a rapid onset of immune response with a single dose of VLA1553 between 7- and 14-days post-vaccination11. This was later confirmed in a further analysis of the Phase 1 data12, which showed that 100% of vaccinated individuals reached the immune threshold13 established with the FDA at day 14. Additionally, VLA1553 was able to demonstrate a robust immune response which was sustained for 12 and 24 months by 99% and 97% of participants, respectively, and was equally durable in younger and older adults1415. This dedicated antibody persistence trial (VLA1553-303) will continue to evaluate persistence for a period of at least five years. A clinical study in adolescents, VLA1553-321, is ongoing in Brazil, for which Valneva reported initial safety data in August 202316. Funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and conducted in collaboration with Instituto Butantan, the VLA1553-321 adolescent trial is intended to support the label extension to this age group following initial approvals in adults. The trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations. Additionally, the Company initiated a Phase 2 pediatric trial in children aged 1 to 11 years, VLA1553-221, in January 202417 to support a Phase 3 pivotal pediatric study and potentially extend the label to this age group following initial regulatory approvals in adults and possibly in adolescents. THIRD-PARTY DISTRIBUTION Valneva distributes certain third-party vaccines in countries where it operates its own marketing and sales infrastructure. The Company notably has distribution agreements with Bavarian Nordic18 and VBI Vaccines19. In the year ended December 31, 2023, third-party product sales grew 34% to €35.7 million compared to €26.5 million in the year ended December 31, 2022. Clinical Stage Vaccine Candidates LYME DISEASE VACCINE CANDIDATE – VLA15 Phase 3 study ongoing Valneva and Pfizer are developing VLA15, a Phase 3 vaccine candidate targeting Borrelia, 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 the United States and Europe. VLA15 is the only Lyme disease program in late-stage 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 observed20,21,22. These include the announcement in September 2023 of positive Phase 2 pediatric and adolescent immunogenicity and safety data following a booster vaccination with VLA15. 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). The safety and tolerability pro VLA15 after a booster dose was consistent with previous studies23. 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 Europe24. Recruitment completion for the study was announced in December 2023. 9,437 participants five years of age and older were enrolled in the trial and will receive, as part of the primary series, three doses of VLA15 or a saline placebo (1:1 ratio) within the first year, and one booster dose approximately one year after vaccination with the first three doses25. The VALOR study is currently ongoing and is designed to follow vaccinated participants over two consecutive tick seasons. In the second quarter of 2024, participants enrolled in the first cohort will receive their booster vaccination and participants of the second cohort will receive the last of their initial three doses ahead of the 2024 tick season. Topline data from the VALOR trial are expected by the end of 2025, with the aim for Pfizer to submit a Biologic License Application to the FDA and Marketing Authorization Application to the EMA in 2026, subject to positive data. ZIKA VACCINE CANDIDATE – VLA1601 Entering Phase 1, further program evaluation planned VLA1601 is a highly purified inactivated, adjuvanted vaccine candidate against the mosquito-borne viral disease caused by the Zika virus (ZIKV). Disease outbreaks have been reported in tropical Africa, Southeast Asia, the Pacific Islands, and, since 2015, in the Americas. Zika virus transmission persists in several countries in the Americas and in other endemic regions. To date, a total of 89 countries and territories have reported evidence of mosquito transmitted Zika virus infection26; however, surveillance remains limited globally. There are no preventive vaccines or effective treatments available and, as such, Zika remains a public health threat and is included in the Food and Drug Administration’s Tropical Disease Priority Review Voucher Program27. VLA1601 is being developed on the original manufacturing platform of Valneva’s licensed Japanese Encephalitis vaccine IXIARO®, which was further optimized to develop the Company’s inactivated, adjuvanted COVID-19 vaccine VLA2001, the first one to receive a standard marketing authorization in Europe28. Valneva reported Phase 1 results from its first-generation Zika vaccine candidate in 2019 showing excellent immunogenicity and safety results in all tested doses and schedules29. The Company now expects to start the clinical evaluation of its second-generation vaccine in the coming weeks. A vaccine against the Zika virus (ZIKV) would nicely complement Valneva’s portfolio of travel vaccines against mosquito-borne diseases, which already includes IXCHIQ® and IXIARO®. 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 mononucleosis30 and is strongly associated with the development of several types of cancer31 and multiple sclerosis32. Valneva has also been working on a vaccine candidate targeting the human metapneumovirus (hMPV), which is a major worldwide respiratory pathogen that causes acute upper and lower respiratory tract infection33 and is exploring potential partnering opportunities. Additionally, Valneva initiated pre-clinical work on vaccine candidates against different enteric diseases. Full Year 2023 Financial Review (Audited34, consolidated under IFRS) Revenues Valneva’s total revenues were €153.7 million in 2023 compared to €361.3 million in 2022. Total revenues in 2022 included €280.0 million of revenue recognition mainly related to the COVID-19 supply agreements in the prior year. Valneva’s total product sales reached €144.6 million in 2023 compared to €114.8 million in 2022. Currency fluctuations of €2.8 million adversely impacted product sales. COVID-19 vaccine sales in 2023 amounted to €5.7 million compared to €29.6 million in 2022. Excluding COVID-19, product sales reached €138.9 million in 2023 compared to €85.2 million in 2022, an increase of 63%. IXIARO®/JESPECT® sales were €73.5 million in 2023 compared to €41.3 million in 2022. The 78% increase in sales is primarily the result of the continued travel market recovery, as well as price increases. The increase in IXIARO®/JESPECT® product sales included an adverse €1.5 million foreign currency impact. DUKORAL® sales were €29.8 million in 2023 compared to €17.3 million in 2022. This 72% increase is also a result of the significant recovery in the private travel markets and price increases. Foreign currency fluctuations reduced DUKORAL® sales by €0.9 million. Third Party product sales were €35.7 million in 2023 compared to €26.5 million in 2022, a 34% increase which was mainly driven by sales of Rabipur®/RabAvert® and Encepur® under the distribution agreement with Bavarian Nordic. Other revenues, including revenues from collaborations, licensing and services amounted to €9.1 million in 2023 compared to €246.5 million in 2022. Other revenues in 2022 included COVID related one-time effects of €280.0 million consisting of released refund liability as a result of the settlement with the UK government, as well as released non-refundable advance payments from European Member States, partially offset by €45.9 million of negative revenue resulting from an increase in the refund liability linked to the amended VLA15 collaboration and license agreement with Pfizer. Operating Result and adjusted EBITDA Costs of goods and services sold (COGS) were €100.9 million in 2023. The gross margin on commercial product sales amounted to 46.0% compared to 45.5% in 2022. COGS of €35.1 million related to IXIARO® product sales, yielding a product gross margin of 52.3%. COGS of €17.1 million related to DUKORAL® product sales, yielding a product gross margin of 42.4%. Of the remaining COGS in 2023, €22.8 million related to the third-party products distribution business, €5.3 million to VLA2001 and €10.2 million to cost of services. In 2022, overall COGS were €324.4 million, of which €314.7 million related to cost of goods and €9.7 million related to cost of services. In 2022, COGS of the COVID-19 vaccine program amounted to €267.1 million and included effects from the significant reduction of sales volumes to the European Union Member States which resulted in impairment of fixed assets and inventories. Research and development expenses amounted to €59.9 million in 2023, compared to €104.9 million in 2022. This decrease was exclusively driven by the lower spend on Valneva’s COVID-19 vaccine, VLA2001. At the same time, costs related to the Zika vaccine candidate increased as the Company has been working towards re-initiation of clinical development. Marketing and distribution expenses in 2023 amounted to €48.8 million compared to €23.5 million in 2022. The increase is mainly related to €20.7 million of expenses associated with launch preparations for IXCHIQ® (2022: €7.3 million). In 2023, general and administrative expenses increased to €47.8 million from €34.1 million in 2022. In the previous year 2022, COGS, research and development, marketing and distribution as well as general and administrative expenses all benefited from a non-cash accrual adjustment related to the positive effect of the Company’s share price development on employee share-based compensation programs. This income compares to an expense in 2023. Other income, net of other expenses, increased to €21.5 million in 2023 from €12.2 million in 2022. The increase was mainly driven by grant income received from Scottish Enterprise in the amount of €11.1 million and by a gain from a settlement with a supplier in connection with COVID-19 activities of €4.7 million. Valneva recorded an operating loss of €82.1 million in 2023 compared to an operating loss of €113.4 million in 2022. The higher loss in 2022 was primarily driven by non-recurring expenses of goods and services related to valuation of inventory, and onerous agreement provisions for material in connection with our COVID-19 vaccine and its program suspension. Adjusted EBITDA (as defined below) loss in 2023 was €65.2 million, nearly unchanged to the Adjusted EBITDA loss of €69.2 million in 2022. Net Result In 2023, Valneva generated a net loss of €101.4 million compared to a net loss of €143.3 million in 2022. Finance expense and currency effects in 2023 resulted in a net finance expense of €16.5 million, compared to a net finance expense of €31.4 million in 2022. This increase in finance income/expenses, net was mainly due to foreign exchange gains of €5.6 million in 2023 compared to a loss of €12.6 million in 2022, primarily related to the development of the USD and GBP exchange rates. Cash Flow and Liquidity Net cash used in operating activities amounted to €202.7 million in 2023 compared to €245.3 million of cash used in operating activities in 2022. Cash outflows in 2023 were derived from the loss for the period amounting to €101.4 million and from working capital in the amount of €145.6 million, which largely were related to payments to Pfizer in conjunction with Valneva’s contribution to the Phase 3 costs of the Lyme VLA15 R&D program, reducing the refund liability. Cash outflows from investing activities amounted to €20.6 million in 2023 compared to €29.1 million in 2022, both mainly a result of construction activities across production sites in Scotland and Sweden, as well as equipment purchases. Net cash generated from financing activities decreased to €63.1 million in 2023 from €215.1 million in 2022. Cash inflows in 2023 were primarily due to €81.1 million of net proceeds from the additional tranches from the loan agreement with Deerfield and OrbiMed drawn in the second half of the year. Cash inflows in 2022 were mainly a result of proceeds from the equity subscription agreement with Pfizer, proceeds from a global offering as well as a draw-down of the loan provided by Deerfield and OrbiMed. Cash and cash equivalents were €126.1 million as at December 31, 2023, compared to €289.4 million as at December 31, 2022. Cash and Cash equivalents in 2023 included the drawing of a total of $100 million from the Deerfield and OrbiMed loan agreement as well as significant payments made to Pfizer related to the companies’ Phase 3 Lyme disease study “VALOR”. Cash at the end of 2023 does not include $103 million of proceeds from the PRV, which Valneva sold in February 2024. Non-IFRS Financial Measures 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 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) for the period before income tax, finance income/expense, foreign exchange gain/(loss), results from investments in associates, amortization, depreciation, and impairment (excluding impairment loss of disposal). A reconciliation of Adjusted EBITDA to net loss for the period, which is the most directly comparable IFRS measure, is set forth below: € in million Twelve months ending December 31 (consolidated per IFRS) 2023 2022 Loss for the period (101.4) (143.3) Add: Income tax expense 2.8 (1.5) Total Finance income (1.2) (0.3) Total Finance expense 23.3 19.1 Foreign exchange gain/(loss) – net (5.6) 12.6 Result from investments in associates - - Amortization 5.8 7.0 Depreciation 11.8 14.0 Impairment (0.7) 23.2 Adjusted EBITDA (65.2) (69.2) 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, as well as vaccine candidates against the Zika virus and other global public health threats. About IXCHIQ® In the U.S., IXCHIQ® is a live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under FDA’s accelerated approval pathway, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies. Pleaseclick herefor full Prescribing Information for IXCHIQ®. Valneva Investor and Media Contacts Laetitia Bachelot-Fontaine VP, Global Communications and European Investor Relations M +33 (0)6 4516 7099 investors@valneva.com Joshua Drumm, Ph.D. VP, Global Investor Relations M +001 917 815 4520 joshua.drumm@valneva.com Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to guidance for certain financial results in fiscal year 2024 and mid-term outlook on financial results, cash position, and other business developments, including results of ongoing clinical trials, the timing and possible occurrence of further or initial regulatory approvals of its product candidates, the anticipated size of markets for its approved products and sales of those products, receipt of funding from external sources, supply of products sold by Valneva, and relationships with current business partners. 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. These risks and uncertainties include those developed or identified in any public documents filed with the French financial markets authority (Autorité des marchés financiers) and the U.S. Securities and Exchange Commission made or to be made by Valneva. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines (including in relation to organic or strategic expansion of Valneva’s clinical pipeline), unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis and other global economic or political events, the ability to obtain or maintain patent or other proprietary intellectual property protection, the cancellation of existing contracts, the impact of a pandemic, and changes in the regulatory environment in which Valneva operates. The occurrence of any of these risks and uncertainties 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. 1 Valneva Announces Sale of Priority Review Voucher for $103 Million - Valneva 2 Valneva Announces Extension of the Interest-Only Period of Its Debt Facility with Deerfield and OrbiMed - Valneva 3 ACIP Vaccine Recommendations and Schedules | CDC 4 Valneva Reports Full Year 2023 Revenue and Cash, Provides First 2024 Guidance - Valneva 5 Valneva Announces Extension of the Interest-Only Period of Its Debt Facility with Deerfield and OrbiMed - Valneva 6 Valneva Announces Extension of the Interest-Only Period of Its Debt Facility with Deerfield and OrbiMed - Valneva 7 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. 8 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. 9 ACIP Vaccine Recommendations and Schedules | CDC 10 Valneva Announces Publication of its Chikungunya Vaccine Candidate Phase 3 Data in The Lancet - Valneva 11 Wressnigg N, Hochreiter R, Zoihsl O, Fritzer A, Bézay N, Klingler A, Lingnau K, Schneider M, Lundberg U, Meinke A, Larcher-Senn J, Čorbic-Ramljak I, Eder-Lingelbach S, Dubischar K, Bender W. "Single-shot live-attenuated chikungunya vaccine in healthy adults: a phase 1, randomised controlled trial." Lancet ID, 2020: 20(10):1193-1203. 12 McMahon R, Töpfer S, Schneider M, Hadl S, Hochreiter R, Kosulin K, Mader R, Zoihsl O, Wressnigg N, ​Dubischar K, Buerger V, Eder-Lingelbach S, Jaramillo JC. "One year antibody persistence and safety of a live-attenuated chikungunya virus (CHIKV) vaccine candidate (VLA1553) in adults aged 18 years and above." CISTM. Basel, 2023. 13 Seroresponse 14 Valneva Reports Positive 12-Month Antibody Persistence Data for Single-Shot Chikungunya Vaccine Candidate - Valneva 15 Valneva Reports Positive 24-Month Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ® - Valneva 16 Valneva Reports Positive Initial Phase 3 Safety Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate - Valneva 17 Valneva Vaccinates First Participant in Pediatric Trial of Single-Shot Chikungunya Vaccine - Valneva 18 Valneva and Bavarian Nordic Announce Marketing and Distribution Partnership - Valneva 19 Valneva and VBI Vaccines Announce European Partnership for Marketing and Distribution of PreHevbri® - Valneva 20 Valneva and Pfizer Report Six-Month Antibody Persistence Data in Children and Adults for Lyme Disease Vaccine Candidate - Valneva 21Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15 - Valneva 22 Valneva and Pfizer Report Further Positive Phase 2 Results, Including Booster Response, for Lyme Disease Vaccine Candidate - Valneva 23 Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate - Valneva 24 Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15 - Valneva 25 Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15 - Valneva 26 Zika virus disease (who.int) 27 Tropical Disease Priority Review Voucher Program | FDA 28 Valneva Receives Marketing Authorization in Europe for Inactivated Whole-Virus COVID-19 Vaccine VLA2001 - Valneva 29 Emergent Biosolutions and Valneva Report Positive Phase 1 Results for Their Vaccine Candidate Against the Zika Virus - Valneva 30 . 31 's,some%20cases%20of%20stomach%20cancer. 32 33 34 The audit procedures on the consolidated financial statements have been performed. The audit report will be issued upon finalization of procedures regarding the filing. Attachment 2024_03_20_VLA_FY2023_Results_PR_Annex_EN_Final

Completed Stage 2 enrollment in the NAVAL-1 trial of Nana-val in patients with relapsed or refractory EBV+ peripheral T-cell lymphoma supporting its speed to market strategy; topline results from Stage 1 of the study expected in the second quarter of 2024 Completed enrollment into first split daily dosing cohort of the Phase 1b/2 study of Nana-val in patients with advanced EBV+ solid tumors Strengthened balance sheet following receipt of non-dilutive proceeds of $5.0 million through monetization of a pre-commercialization, event-based milestone from Day One Biopharmaceuticals, Inc., extending cash runway into mid-Q1 2025 SAN DIEGO, March 07, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today reported financial results for the fourth quarter and full-year of 2023 and provided a business update. “Nana-val is a first-in-class, all-oral combination treatment regimen that has entered late-stage development to target and treat EBV-associated cancers. Our near-term goal is to address the high unmet medical need of patients living with relapsed or refractory EBV-positive PTCL by advancing Nana-val in this lead indication through regulatory approval as quickly as possible,” said Mark Rothera, President and Chief Executive Officer of Viracta. “We are pleased to have successfully completed patient enrollment across both Stage 1 and Stage 2 of the PTCL cohort in our pivotal NAVAL-1 trial. Building on this momentum, we anticipate reporting topline data from Stage 1 in the second quarter of 2024 and engaging with the FDA on a potential accelerated approval pathway in mid-2024.” Clinical Trial Updates and Anticipated Milestones Pivotal NAVAL-1 trial of Nana-val (nanatinostat in combination with valganciclovir) in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma Clinical Trial Updates: Completed enrollment of Stage 1 in the R/R EBV+ PTCL cohort (in patients treated with nanatinostat with [n=10] or without [n=10] valganciclovir) in the fourth quarter of 2023. Completed enrollment of Stage 2 in the R/R EBV+ PTCL cohort of patients treated with Nana-val (n=21, Stage 1 + Stage 2 patients) in the first quarter of 2024. Amended protocol to additionally enable enrollment of second-line R/R EBV+ DLBCL patients and R/R EBV+ PTLD patients, including pediatric EBV+ PTLD patients ≥ 12 years of age. Anticipated 2024 Milestones: Present topline Stage 1 data from both arms of the R/R EBV+ PTCL cohort (in patients treated with nanatinostat with [n=10] or without [n=10] valganciclovir) in the second quarter of 2024, with an aim to clearly delineate the differentiation of Nana-val’s ‘kick and kill’ mechanism of action. Engage with U.S. Food and Drug Administration (FDA) in mid-2024, to align on requirements for accelerated approval. Enroll patients into the post-Phase 2 expansion cohort to support potential accelerated approval. Present Stage 1 + Stage 2 data (n=21) in the R/R EBV+ PTCL cohort in patients treated with Nana-val in the third quarter of 2024. Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma (DLBCL) and R/R EBV+ post-transplant lymphoproliferative disorder (PTLD) by year-end 2024. Phase 1b/2 trial of Nana-val in patients with recurrent/metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors (Study 301) Clinical Trial Updates: In December 2023, the FDA granted an orphan drug designation (ODD) to Nana-val for the treatment of NPC, the fifth ODD granted to Nana-val by the FDA, the seventh ODD for Nana-val globally, and the first ODD granted to Nana-val in EBV+ solid tumors. Presented data at ESMO Asia Congress 2023 that confirmed partial responses without dose-limiting toxicities through the initial five dose cohorts, supporting continued dose escalation to potentially enhance Nana-val’s antitumor activity. Completed enrollment of the sixth dose cohort of patients with R/M EBV+ NPC, evaluating the novel split daily dosing (SDD) regimen. Anticipated 2024 Milestones: Determine the recommended Phase 2 dose (RP2D) in the second half of 2024. Initiate a dose-optimization cohort to confirm the RP2D as part of the study’s Phase 2 expansion by year-end 2024. Business Updates Executed an amended license agreement with Day One Biopharmaceuticals In March 2024, to receive non-dilutive proceeds of $5.0 million related to monetization of a pre-commercialization, event-based milestone from Day One Biopharmaceuticals, Inc. Executed an amended Royalty Purchase Agreement with XOMA Amended the Royalty Purchase Agreement with XOMA, modifying the economic value-share under the Royalty Purchase Agreement by which the Company has retained the right, under certain circumstances, to participate in a pre-commercialization event-based milestone up to $5.0 million. Executed the second amendment under the SVB-Oxford Loan Facility Amended the SVB-Oxford Loan Facility, providing for a modification of the loan amortization period and a pro-rata reduction in the prospective debt amortization schedule, in exchange for a partial prepayment of the term loan. Pursuant to the terms of the second amendment, the Company has agreed to remit a prepayment of $5.0 million toward the outstanding principal, plus a pro-rata portion of the final payment, by March 15, 2024. Under the terms of the amendment, principal amortization will be deferred between March 2024 and June 2024, totaling approximately $2.9 million. Amortization payments will recommence in July 2024, reflecting the prepayment and reducing prospective amortization payments in 2024 by approximately $3.3 million, in addition to significantly reducing interest owed over the term of the loan. There were no changes to the maturity date of the term loan, which is November 2026. “We are pleased to have strengthened our balance sheet through the imminent receipt of $5 million in non-dilutive capital at this important time,” said Dan Chevallard, Chief Operating Officer and Chief Financial Officer of Viracta. “The proceeds will be used to make a partial prepayment of our outstanding debt balance, while also enabling a concurrent amendment to our credit facility to avail ourselves of an additional interest-only period through June 2024, and further reduce future amortization and interest payments reflecting the prepayment. Pro forma for this prepayment, we will have reduced our debt balance by over 25% since year-end to $18.6M and anticipate ending 2024 with less than $15 million in debt outstanding. The totality of this coordinated set of transactions will extend our cash runway into mid-Q1 2025 and provides a meaningful aggregate cash impact to Viracta well in excess of the proceeds.” Fourth-Quarter and Full-Year 2023 Financial Results Cash position – Cash, cash equivalents, and short-term investments totaled approximately $53.7 million as of December 31, 2023. Pro forma for the aforementioned business transactions, our cash runway to fund operations is extended into mid-Q1 2025. Research and development expenses – Research and development expenses were approximately $9.4 million and $6.7 million for the three months ended December 31, 2023 and 2022, respectively. Research and development expenses increased to $33.4 million compared to $26.3 million for the years ended December 31, 2023 and 2022, respectively. The increase in research and development expenses in 2023 was primarily driven by increases in costs incurred to support the advancement and expansion of our clinical development programs, including incremental costs to support NAVAL-1, our pivotal trial of Nana-val in patients with R/R EBV+ lymphomas, and our Phase 1b/2 study of Nana-val in patients with advanced EBV+ solid tumors, as well as an increase in personnel-related costs. General and administrative expenses – General and administrative (G&A) expenses were approximately $4.2 million and $4.9 million for the three months ended December 31, 2023 and 2022, respectively, compared to $17.3 million and $24.3 million for the years ended December 31, 2023 and 2022. The decrease in G&A expenses year over year was largely due to a one-time expense associated with the modification of certain equity awards totaling $5.6 million and $0.8 million in severance-related charges associated with the transition of the former Chief Executive Officer in 2022. The decrease over the comparative three-month period was primarily due to a decrease in share-based compensation expense and corporate liability insurance premiums. Net loss – Net loss was approximately $13.8 million, or $0.35 per share (basic and diluted), for the quarter ended December 31, 2023, compared to a net loss of $10.3 million or $0.27 per share (basic and diluted), for the same period in 2022. Net loss was approximately $51.1 million, or $1.32 per share (basic and diluted), for the year ended December 31, 2023, compared to a net loss of $49.2 million or $1.30 per share (basic and diluted), for the same period in 2022. About the NAVAL-1 Trial NAVAL-1 (NCT05011058) is a global, multicenter, clinical trial of Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma. This trial employs a Simon two-stage design where, in Stage 1, participants are enrolled into one of three indication cohorts based on EBV+ lymphoma subtype. If two objective responses are achieved within a lymphoma subtype in Stage 1 (n=10), then additional patients will be enrolled in Stage 2 for a total of 21 patients. EBV+ lymphoma subtypes demonstrating promising antitumor activity in Stage 2 may be further expanded following discussion with regulators to potentially support registration. About the Phase 1b/2 Study of Nana-val in Patients with Advanced EBV+ Solid Tumors (Study 301) This Phase 1b/2 trial (NCT05166577) is an open-label, multinational clinical trial evaluating Nana-val alone and in combination with pembrolizumab. The Phase 1b dose escalation part is designed to evaluate safety and to select the recommended Phase 2 dose (RP2D) of Nana-val in patients with recurrent or metastatic (R/M) Epstein-Barr virus-positive (EBV+) nasopharyngeal carcinoma (NPC). Along with the U.S. Food and Drug Administration’s Project Optimus initiative, at the start of Phase 2, up to 40 patients with R/M EBV+ NPC will be randomized to receive either the RP2D or a dose level below the RP2D in a dose-optimization cohort. Once the RP2D has been confirmed, up to 60 patients with R/M EBV+ NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab to further evaluate antitumor activity, safety and tolerability, pharmacokinetics, and potential pharmacodynamic biomarkers. Additionally, patients with other advanced EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort. About Nana-val (Nanatinostat and Valganciclovir) Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory (R/R) EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 clinical trial in patients with recurrent or metastatic (R/M) EBV+ NPC and other advanced EBV+ solid tumors. About Peripheral T-Cell Lymphoma T-cell lymphomas comprise a heterogeneous group of rare and aggressive malignancies, including peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) and angioimmunoblastic T-cell lymphoma (AITL). There are approximately 5,600 newly diagnosed T-cell lymphoma patients and approximately 2,600 newly diagnosed PTCL-NOS and AITL patients in the U.S. annually. Approximately 70% of these patients are either refractory to first-line therapy, or eventually experience relapse of their disease. Clinical trials are currently recommended for all lines of PTCL therapy, and most patients with R/R PTCL have poor outcomes, with median progression-free survival and median overall survival times reported to be 3.7 and 6.5 months, respectively. Approximately 40% to 65% of PTCL is associated with EBV, the incidence of EBV+ PTCL varies by geography, and reported outcomes for patients with EBV+ PTCL are inferior to those whose disease is EBV-negative. There is no approved targeted treatment specific for EBV+ PTCL, and therefore this represents a high unmet medical need. About EBV-Associated Cancers Approximately 90% of the world's adult population is infected with EBV. Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient's life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV-positive (EBV+) lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer. About Viracta Therapeutics, Inc. Viracta is a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide. Viracta’s lead product candidate is an all-oral combination therapy of its proprietary investigational drug, nanatinostat, and the antiviral agent valganciclovir (collectively referred to as Nana-val). Nana-val is currently being evaluated in multiple ongoing clinical trials, including a pivotal, global, multicenter, open-label Phase 2 basket trial for the treatment of multiple subtypes of relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma (NAVAL-1), as well as a multinational, open-label Phase 1b/2 clinical trial for the treatment of patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors. Viracta is also pursuing the application of its “Kick and Kill” approach in other virus-related cancers. For additional information, please visit . Forward-Looking Statements This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the details, timeline and expected progress for Viracta's ongoing and anticipated clinical trials and updates regarding the same, the Company’s expectations related to the FDA submission process and timelines, expectations regarding our target patient populations, and expectations regarding our cash runway. Risks and uncertainties related to Viracta that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but are not limited to: Viracta's ability to successfully enroll patients in and complete its ongoing and planned clinical trials; Viracta's plans to develop and commercialize its product candidates, including all oral combinations of nanatinostat and valganciclovir; the timing of initiation of Viracta's planned clinical trials; the timing of the availability of data from Viracta's clinical trials; previous preclinical and clinical results may not be predictive of future clinical results; the timing of any planned investigational new drug application or new drug application; Viracta's plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits, and market acceptance of Viracta's product candidates; Viracta's ability to manufacture or supply nanatinostat, valganciclovir, and pembrolizumab for clinical testing; and Viracta's estimates regarding its ability to fund ongoing operations into 2025, future expenses, capital requirements, and need for additional financing in the future. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Viracta's reports and other documents that Viracta has or will file, with the SEC from time to time and available at . The forward-looking statements included in this communication are made only as of the date hereof. Viracta assumes no obligation and does not intend to update these forward-looking statements, except as required by law or applicable regulation. Investor Relations Contact: Ashleigh Barreto Head of Investor Relations & Corporate Communications Viracta Therapeutics, Inc. abarreto@viracta.com SOURCE Viracta Therapeutics, Inc. -- Financial tables attached – Viracta Therapeutics, Inc. Selected Balance Sheet Highlights (in thousands) December 31, December 31, 2023 2022 Cash, cash equivalents and short-term investments $ 53,691 $ 91,043 Total assets $ 56,692 $ 95,991 Total liabilities $ 38,373 $ 34,888 Stockholders' equity $ 18,319 $ 61,103 Viracta Therapeutics, Inc. Condensed Consolidated Statement of Operations and Comprehensive Loss (in thousands except share and per share data) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Operating expenses: Research and development $ 9,406 $ 6,703 $ 33,369 $ 26,262 General and administrative 4,154 4,871 17,324 24,327 Total operating expenses 13,560 11,574 50,693 50,589 Loss from operations (13,560 ) (11,574 ) (50,693 ) (50,589 ) Total other income (expense) (205 ) 1,248 (365 ) 1,392 Net loss (13,765 ) (10,326 ) (51,058 ) (49,197 ) Unrealized gain (loss) on short-term investments 73 21 187 (178 ) Comprehensive loss (13,692 ) (10,305 ) (50,871 ) (49,375 ) Net loss per share, basic and diluted $ (0.35 ) $ (0.27 ) $ (1.32 ) $ (1.30 ) Weighted-average common shares outstanding, basic and diluted 38,790,480 38,315,658 38,624,462 37,790,981