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Core Insights - Vaxcyte, Inc. is advancing its VAX-31 infant Phase 2 randomized, dose-finding study to the final stage, focusing on a 31-valent pneumococcal conjugate vaccine designed to prevent invasive pneumococcal disease (IPD) in infants [1][2][3] - The VAX-31 Optimized Dose aims to elicit stronger immune responses in infants, with the majority of serotypes dosed at 4.4mcg and the balance at 3.3mcg, potentially covering approximately 92% of IPD and 93% of acute otitis media in U.S. children under five [1][3][6] - The company plans to release topline data from the primary immunization series and booster dose by the end of the first half of 2027 [1][2] Company Overview - Vaxcyte is a clinical-stage vaccine innovation company focused on developing high-fidelity vaccines to combat bacterial diseases [1][8] - The company is also developing VAX-24, a 24-valent PCV candidate, which aims to cover more serotypes than any existing infant PCV on the market [8][9] - Vaxcyte utilizes the XpressCF platform for cell-free protein synthesis, enhancing its ability to produce complex vaccines [9] Study Details - The VAX-31 infant Phase 2 study is a randomized, double-blind, active-controlled trial evaluating safety, tolerability, and immunogenicity compared to Prevnar 20 (PCV20) [4][10] - The study will enroll approximately 900 participants, including those previously in the Low Dose arm, and will assess immune responses through serotype-specific immunoglobulin G (IgG) seroconversion rates [2][10] - The study consists of three stages, with the first stage completed and the second stage modified to include the new Optimized Dose arm [4][10] Disease Context - Pneumococcal disease, caused by Streptococcus pneumoniae, is a leading cause of vaccine-preventable deaths among children under five, with significant morbidity and mortality [5][6] - The disease can lead to severe conditions such as meningitis and bacteremia, highlighting the urgent need for a broader-spectrum vaccine [5][6] Regulatory Status - The FDA has expanded the Breakthrough Therapy designation for VAX-31 to include the prevention of pneumonia caused by Streptococcus pneumoniae, indicating potential substantial improvement over existing therapies [7]

Core Insights - Valneva SE announced positive immunogenicity and safety data from the Phase 2 study of its Lyme disease vaccine candidate, VLA15, showing strong immune response and favorable safety profile after a third booster dose [1][3][4] Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [12] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [13] Vaccine Development - VLA15 is the only Lyme disease vaccine candidate in advanced clinical development, with two Phase 3 trials nearing completion [2][6] - The vaccine targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria causing Lyme disease, and aims to inhibit the bacterium's ability to infect humans [6][8] Clinical Study Results - The Phase 2 study (VLA15-221) involved 560 healthy participants aged 5 to 65, demonstrating a 100% seroconversion rate across all age groups after the third booster dose [3][9] - The safety profile after the third booster was consistent with previous doses, with no safety concerns reported by the independent Data Monitoring Committee [4][7] Market Need - There are currently no approved human vaccines for Lyme disease, with approximately 476,000 cases diagnosed annually in the U.S. and 132,000 in Europe, highlighting a significant unmet medical need [2][11] - The geographic expansion of Lyme disease increases the urgency for vaccination solutions [3][11] Collaboration - Valneva has a collaboration agreement with Pfizer for the development and commercialization of VLA15, initiated in April 2020 [4]

Core Insights - Evaxion A/S is a clinical-stage TechBio company focused on developing AI-Immunology™ powered vaccines and will present updates at various conferences in the latter half of 2025 [1][3][7] Company Updates - The company will engage with stakeholders and potential partners at multiple conferences across the US, Europe, and Asia to explore business partnerships and scientific collaborations [2][5] - Evaxion is particularly excited about presenting two-year clinical data for its personalized cancer vaccine EVX-01 at the ESMO congress in October 2025 [3][5] Conference Participation - Evaxion's conference schedule includes: - Vaccine Congress, September 7-10, Kyoto - HC Wainwright Global Investment Conference, September 8-10, New York - ESCMID Conference on vaccines, September 10-13, Lisbon - Lake Street Best Ideas Growth Conference, September 12, New York - HC Andersen seminar, September 18, Copenhagen - Vax On Vaccines: Present and future in oncology, October 1, Milan - BiotechX Europe, October 6-8, Basel - World Vaccine Congress Europe, October 14-16, Amsterdam - ESMO Congress 2025, October 17-21, Berlin - Society for Immunotherapy of Cancer (SITC) 2025, November 5-9, National Harbor - Vaccines Summit, November 13-15, Boston - NextGen Omics, November 13-14, London [5][6] Company Background - Evaxion utilizes its proprietary AI platform, AI-Immunology™, to develop novel immunotherapies targeting cancer, bacterial diseases, and viral infections, aiming to transform patient care with innovative treatment options [6][7]

Core Viewpoint - Bavarian Nordic A/S is undergoing a voluntary public takeover offer from Innosera ApS, backed by Nordic Capital Fund XI and Permira, with the Board of Directors recommending shareholders accept the offer as it presents immediate and attractive value [1][2]. Company Overview - Bavarian Nordic has evolved into a leading vaccine company since 2018, receiving multiple unsolicited inquiries for potential takeover bids [2]. - The company specializes in innovative vaccines, including mpox and smallpox vaccines, and has a strong portfolio of travel vaccines [4]. Offer Details - The Board of Directors has conducted a thorough analysis of the takeover offer, considering the company's financials, performance, and future prospects [2]. - The offer is positioned as an opportunity for shareholders to realize immediate value, which the Board finds attractive [2]. - The Board Statement regarding the offer is available in both Danish and English, with the Danish version prevailing in case of discrepancies [2][3]. Communication and Availability - Offer-related documents, including the Board Statement, are accessible on Bavarian Nordic's website, with notifications sent to registered shareholders [3].

Core Viewpoint - Innosera ApS, controlled by Nordic Capital Fund XI and Permira, has made a voluntary all-cash takeover offer for Bavarian Nordic A/S at DKK 233.0 per share, with a revised minimum acceptance condition of 75% of shares [1][3]. Group 1: Offer Details - The takeover offer is for all issued and outstanding shares of Bavarian Nordic, excluding treasury shares [1]. - The offer document has been approved by the Danish Financial Supervisory Authority and includes an acceptance form [1]. - The initial minimum acceptance condition was over 90% but has been lowered to 75% [3]. Group 2: Shareholder Guidance - Shareholders are advised to read the Offer Document and the forthcoming Board Statement in full before making a decision [4]. - The Board of Directors will issue a statement regarding the Offer as soon as possible [2]. Group 3: Company Background - Bavarian Nordic is a global vaccine company focused on innovative vaccines, including mpox and smallpox vaccines, and has a strong portfolio of travel vaccines [7].

Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [7] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [8] Recent Developments - The FDA has suspended the license for Valneva's chikungunya vaccine IXCHIQ® due to four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness, effective immediately [1][2] - This suspension follows the FDA's earlier decision to lift a recommended pause for individuals aged 60 and older, based on an investigation of reported SAEs primarily among elderly individuals with multiple underlying health conditions [2] Financial Impact - Sales of IXCHIQ® contributed €7.5 million to Valneva's total product sales of €91 million in the first half of 2025, with a significant portion attributed to a one-time delivery of vaccine doses for a chikungunya outbreak in La Reunion [4] - Valneva is evaluating the potential financial impact of a permanent withdrawal of the IXCHIQ® license in the United States but has not modified its revenue guidance at this time [4] Commitment to Safety and Access - Valneva is committed to upholding high safety standards and will continue to engage proactively with health authorities in all territories where IXCHIQ® is licensed [3] - The CEO emphasized the company's commitment to maintaining access to IXCHIQ® as a global health tool for addressing chikungunya outbreaks, particularly in low-and-middle-income countries [4] Chikungunya Overview - Chikungunya virus (CHIKV) is a mosquito-borne viral disease that has caused significant outbreaks globally since 2004, with over 3.7 million cases reported in the Americas between 2013 and 2023 [5][6] - The World Health Organization (WHO) has highlighted chikungunya as a major public health problem, with the medical and economic burden expected to grow due to climate change [6]

Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [7] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [8] Recent Developments - The FDA has suspended the license for Valneva's chikungunya vaccine IXCHIQ due to four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness, effective immediately [1][2] - This suspension follows the FDA's earlier decision to lift a recommended pause for individuals aged 60 and older, based on an investigation of reported SAEs [2] Financial Impact - IXCHIQ sales contributed €7.5 million to Valneva's total product sales of €91 million in the first half of 2025, with a significant portion attributed to a one-time delivery of vaccine doses for a chikungunya outbreak in La Reunion [4] Commitment to Safety and Access - Valneva is committed to maintaining high safety standards and will continue to engage with health authorities regarding IXCHIQ [3] - The CEO emphasized the company's commitment to providing access to IXCHIQ globally, especially in low-and-middle-income countries affected by chikungunya outbreaks [4] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease that has been identified in over 110 countries, with significant medical and economic burdens expected to grow due to climate change [5][6] - The World Health Organization (WHO) has highlighted chikungunya as a major public health problem, indicating the ongoing need for effective vaccines [6]

Core Viewpoint - Bavarian Nordic A/S reported strong interim financial results for the first half of 2025, showcasing significant growth in both Travel Health and Public Preparedness segments, while refining its revenue guidance for the year [1][3]. Financial Performance - Revenue for H1 2025 increased by 33% to DKK 2,998 million compared to DKK 2,259 million in H1 2024 [5]. - Travel Health revenue rose by 24% to DKK 1,386 million, driven by demand for rabies and TBE vaccines [5]. - Public Preparedness revenue surged by 51% to DKK 1,546 million, attributed to quarterly phasing of orders [5]. - EBITDA for H1 2025 was DKK 961 million, resulting in an EBITDA margin of 32% [5]. - Full year revenue guidance is narrowed to DKK 6,000-6,600 million, with Travel Health expected to contribute DKK 2,750 million and Public Preparedness narrowed to DKK 3,100-3,700 million [5]. Business Highlights - The launch of the chikungunya vaccine, Vimkunya, has been a significant milestone, with approvals in the US, EU, and UK, and commercial launches in multiple countries [6][7]. - The sale of a Priority Review Voucher generated net proceeds of DKK 810 million, enhancing the company's financial position [6][13]. - The company has secured approximately DKK 3,100 million in contracts for Public Preparedness in 2025, aligning with its targeted guidance [13]. Strategic Outlook - The company maintains its EBITDA margin guidance before special items at 26-30% for 2025, with an expected total EBITDA margin of 40-42% including special items [3][5]. - Recent orders for mpox/smallpox vaccines and the expansion of the Travel Health business are expected to contribute positively to revenue growth [3][13].

Core Viewpoint - Valneva SE has received marketing authorization from Health Canada for its single-dose chikungunya vaccine, IXCHIQ®, for individuals aged 12 years and older, marking a significant milestone in addressing the chikungunya virus [1][3]. Company Developments - IXCHIQ® is now authorized for adults in Canada and has received an adolescent label extension in Europe [1]. - The vaccine demonstrates a sustained immune response for 24 months in 97% of participants, with similar durability across age groups [2]. - Valneva's Chief Medical Officer emphasized the importance of making the vaccine accessible to all age groups, especially in endemic regions [3]. - IXCHIQ® was the first chikungunya vaccine approved in an endemic country, receiving authorization from Brazil earlier this year [3][4]. Industry Context - Chikungunya is increasingly recognized as a public health issue, with recent outbreaks reported in Brazil, India, and China [3][5]. - The World Health Organization has identified chikungunya as a major public health problem, with over 3.7 million cases reported in the Americas between 2013 and 2023 [5]. - Valneva's partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) aims to enhance access to IXCHIQ® in low- and middle-income countries [3][4][6].