Core Insights - Valneva SE has submitted a label extension application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) to expand the use of its chikungunya vaccine, IXCHIQ®, to adolescents aged 12 to 17 years, following a positive opinion from the European Medicines Agency (EMA) for the same extension in the EU [1][2]. Company Developments - IXCHIQ® is the world's first licensed chikungunya vaccine, currently approved for individuals aged 18 and older in the U.S., Europe, Canada, and the UK [2][3]. - Valneva has committed to supplying 40,000 doses of IXCHIQ® to La Réunion, responding to a call from the French government amid ongoing chikungunya outbreaks [3][4]. - The company is focused on expanding the vaccine's accessibility, with positive Phase 3 data showing a 99.1% immune response in adolescents after a single dose, and a sustained 98.3% sero-response rate one year post-vaccination [4][5]. Partnerships and Funding - In Q3 2024, Valneva expanded its partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) through a $41.3 million grant aimed at increasing vaccine access in low- and middle-income countries (LMICs) [5][6]. - An exclusive license agreement was signed with the Serum Institute of India to supply IXCHIQ® in Asia, ensuring affordable pricing for public health markets in LMICs [6][7]. - Valneva previously established a license agreement with Instituto Butantan in Brazil for a local chikungunya vaccine, further enhancing its distribution capabilities in Latin America [7]. Public Health Context - Chikungunya has emerged as a significant public health concern, with outbreaks reported in India, Brazil, and La Réunion, and the World Health Organization (WHO) has identified it as a major public health problem [3][9]. - The chikungunya virus has been reported in over 110 countries since its re-emergence in 2004, with over 3.7 million cases documented in the Americas between 2013 and 2023 [9].

Core Viewpoint - Valneva SE is responding to a chikungunya outbreak in La Réunion by providing 40,000 doses of its vaccine IXCHIQ, with a focus on vaccinating vulnerable populations, particularly adults aged 65 and over with co-morbidities [1][2][4]. Group 1: Company Actions and Vaccine Details - Valneva will supply 40,000 doses of IXCHIQ starting in early April, with the option to provide more doses as needed [1]. - IXCHIQ is the world's first licensed chikungunya vaccine, approved for individuals aged 18 and older in the U.S., Europe, Canada, and the UK, with a recent positive opinion from the EMA for a label extension to individuals aged 12 and older [3][5]. - The company is focused on expanding access to IXCHIQ, including a partnership with CEPI that received a $41.3 million grant to enhance vaccine access in Low- and Middle-Income Countries (LMICs) [5][6]. Group 2: Public Health Context and Response - Chikungunya cases in La Réunion have surged, with 8,600 cases reported and nearly 3,000 new cases in the week of March 3 to 9, 2025, prompting local authorities to implement a Level 4 emergency crisis management plan [2]. - The Haute Autorité de Santé recommended prioritizing vaccination for adults aged 65 and over, especially those with co-morbidities, followed by adults aged 18 and over with co-morbidities [4]. - The CDC has issued a travel alert due to the outbreak, highlighting the potential for transmission to mainland France and other territories [2]. Group 3: Broader Implications and Partnerships - Valneva has signed an exclusive license agreement with the Serum Institute of India to supply IXCHIQ in Asia, ensuring affordable access to public health markets in LMICs [6][7]. - The company previously established a partnership with Instituto Butantan in Brazil for the development and marketing of a local chikungunya vaccine for Latin American countries [7]. - The World Health Organization has identified chikungunya as a significant public health issue, with the disease affecting over 110 countries and the economic impact expected to grow due to climate change [9].

Financial Data and Key Metrics Changes - Revenue for 2024 was $28.7 million compared to $7.4 million in 2023, primarily from government contracts related to BARDA and non-cash royalty revenue from sales of INNOVERE in Japan [25] - The company ended 2024 with cash, cash equivalents, and investments of $51.7 million, and anticipates cash runway into the fourth quarter of 2025 [26] Business Line Data and Key Metrics Changes - The COVID-19 program received an award of approximately $460 million for a 10,000 participant study, with initial enrollment of 400 participants completed [6][7] - The norovirus program initiated a Phase one trial evaluating second-generation oral vaccine constructs against first-generation constructs, with promising preclinical data indicating improved immune responses [10][15] Market Data and Key Metrics Changes - The norovirus market represents a $10 billion annual economic burden in the U.S., affecting approximately 20 million Americans, highlighting the unmet need for effective vaccines [11][62] Company Strategy and Development Direction - The company aims to transform global public health by developing next-generation oral pill vaccines, focusing on pandemic preparedness and addressing the shortcomings of injectable vaccines [4][5] - Vaxart is committed to advancing multiple vaccine programs and exploring strategic partnerships and non-dilutive funding to extend its cash runway [26][55] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenges posed by the regulatory environment but emphasizes the importance of their oral vaccine platform's safety profile and potential for broader acceptance [54] - The company remains optimistic about the progress of its vaccine candidates and looks forward to sharing updates in 2025 and beyond [27] Other Important Information - The company is reviewing preclinical programs for avian influenza and HPV vaccines, with plans for further studies [24] - A stop work order related to the BARDA-funded project has been issued, impacting the planned 10,000 participant study but not affecting the ongoing SENTINEL cohort activities [8][9] Q&A Session Summary Question: Can you discuss the new Phase one study for norovirus and its product type? - The Phase one study will enroll individuals aged 18-49, focusing on second-generation constructs G11 and G24 [31][33] Question: How does the new second-generation product's animal data translate to efficacy? - The new constructs are expected to yield significantly better immune responses in humans, enhancing protective efficacy [37][40] Question: What immunogenicity measurements should be focused on in the Phase one trial? - Key measurements will include serum norovirus blocking antibody responses and fecal IgA levels [45] Question: How does the stop work order impact manufacturing? - The company maintains its own GMP manufacturing facilities, allowing for quick adjustments and confidence in product stability [60] Question: What is the market opportunity for norovirus given existing competition? - There is a significant market opportunity for norovirus vaccines, and the company believes an oral option will be competitive [62]

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on July 22, 2024 Registration Statement No. 333-279153 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Evaxion Biotech A/S (Exact name of Registrant as specified in its charter) The Kingdom of Denmark (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Not applicab ...