Core Insights - Vaxcyte, Inc. announced positive topline results from its Phase 2 dose-finding study for VAX-24, a 24-valent pneumococcal conjugate vaccine (PCV) candidate, demonstrating safety and immunogenicity comparable to Prevnar 20® (PCV20) in healthy infants [2][3][4] Group 1: VAX-24 Study Results - VAX-24 was well-tolerated across all evaluated doses, with a safety profile similar to PCV20, and no serious adverse events related to the vaccine were reported [3][4] - Substantial immune responses were elicited post-primary three-dose immunization series, with robust IgG and opsonophagocytic assay (OPA) responses observed across all doses [4][5] - The mid dose of VAX-24 (2.2 mcg) was selected for further development based on its ability to meet non-inferiority criteria and generate robust immune responses [5][6] Group 2: Future Development Plans - The company plans to advance VAX-24 to a potential Phase 3 program, pending topline data from the VAX-31 Phase 2 study expected in mid-2026 [2][6] - Vaxcyte is also introducing VAX-XL, a third-generation PCV candidate aimed at expanding the spectrum of coverage against pneumococcal disease [2][6] - Key milestones include the initiation of a Phase 3 infant program with either VAX-24 or VAX-31 and the announcement of additional data from ongoing studies [8][10][11] Group 3: Study Design and Participant Information - The VAX-24 Phase 2 study is a randomized, observer-blind, dose-finding study involving 802 healthy infants, assessing safety, tolerability, and immunogenicity [7][9] - The study design includes a primary immunization series of three doses followed by a booster dose, with ongoing evaluations of immunogenicity and safety [9][10] Group 4: Industry Context - Pneumococcal disease remains a significant health threat, particularly in children under five, with Streptococcus pneumoniae being a leading cause of vaccine-preventable deaths globally [14][15] - The development of broader-spectrum vaccines like VAX-24 and VAX-31 is critical to addressing the substantial burden of invasive pneumococcal disease [6][14]

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]