"We are pleased to receive BARDA approval to move forward with dosing in this large-scale study and expect to dose the first patient in this cohort in the second quarter of 2025," said Steven Lo, Chief Executive Officer of Vaxart. "We are deeply grateful for the continued support of our government partners at HHS and BARDA, whose collaboration is critical to advancing our clinical development program." The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study. It is designe ...

Core Insights - Vaxart, Inc. announced the publication of complete data from a Phase 2b challenge study of its first-generation oral pill norovirus vaccine candidate, which met five of its six primary endpoints, demonstrating safety, efficacy, and immunogenicity [1][4] - Machine learning analyses identified functional blocking antibody and fecal IgA as robust correlates of protection, which will inform the development of Vaxart's second-generation norovirus vaccine candidate currently in a Phase 1 clinical trial [1][2] Study Details - The Phase 2b challenge study enrolled 165 healthy adults, randomized to receive either the vaccine candidate targeting norovirus GI.1 genotype or a placebo, with a primary objective to determine vaccine efficacy against norovirus infection and gastroenteritis [3] - Key findings included a 30% relative reduction in norovirus infection for the vaccine group compared to placebo (p=0.003) and a 21% relative reduction in norovirus gastroenteritis, although not statistically significant (p=0.178) [4] Immunogenicity and Safety - The vaccine significantly increased serum IgA, IgG, and norovirus-blocking antibodies (p<0.001 for all endpoints), and stimulated mucosal-homing B cells, increasing norovirus-specific antibodies in saliva, nasal lining fluid, and intestine [4] - The vaccine was reported to be safe and well-tolerated, with no serious vaccine-related events or dose-limiting toxicities, and most adverse events were mild [4] Future Development - Vaxart initiated a Phase 1 trial comparing its first- and second-generation norovirus vaccine candidates in March 2025, aiming to enhance immunogenicity and protection [1][5][6] - The company believes that a safe and effective norovirus vaccine is essential for global health and is confident in its oral pill vaccine platform [6]

Vaxart (VXRT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Edward Berg - Senior Vice President and General CounselSteven Lo - CEO , President & DirectorJames Cummings - Chief Medical OfficerSean Tucker - Founder & Chief Scientific OfficerPhillip Lee - Chief Financial OfficerCheng Li - Director - Equity ResearchMayank Mamtani - Senior Managing Director & Group Head of HealthcareLiang Cheng - Senior Research Associate Operator Greetings. Welcome to Vaxart Business Update and First Quart ...

Vaxart (VXRT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Speaker0 Greetings. Welcome to Vaxart Business Update and First Quarter twenty twenty five Financial Results Conference Call. A question and answer session will follow management's opening remarks. Individual investors may submit written questions to vaxart.com. As a reminder, this conference is being recorded. I would now like to turn the webcast over to your host, Ed Berg, Senior Vice President and General Counsel. Speaker1 Good afternoon, and w ...

Core Insights - Vaxart, Inc. has resumed screening for the 10,000 participant portion of its COVID-19 Phase 2b trial, with dosing expected to start in Q2 2025 [4][7] - The company completed enrollment for its Phase 1 clinical trial of a second-generation oral norovirus vaccine, with topline data anticipated in mid-2025 [4][7] - A new avian influenza vaccine candidate demonstrated 100% protection in a ferret challenge model, contrasting with 0% survival in placebo-treated animals [9] COVID-19 Vaccine Developments - The stop work order for the COVID-19 Phase 2b trial was lifted, allowing Vaxart to proceed with participant screening [4][7] - The company is operating under a Project NextGen award, potentially receiving up to $460.7 million, with $240.1 million currently available [7] - Screening for the trial is currently underway, with dosing expected to begin in the second quarter of 2025 [7] Norovirus Vaccine Developments - Vaxart completed enrollment of 60 participants in its Phase 1 trial for the second-generation oral norovirus vaccine, with results expected in mid-2025 [7] - An independent Data and Safety Monitoring Board recommended the continuation of the study without modifications [7] Avian Influenza Program Developments - The new avian influenza vaccine candidate showed 100% protection against death in a ferret model, with plans to publish the findings in a peer-reviewed forum [9] Financial Results - For Q1 2025, Vaxart reported revenue of $20.9 million, a significant increase from $2.2 million in Q1 2024 [12][18] - Research and development expenses rose to $30.7 million in Q1 2025, compared to $19.0 million in Q1 2024, primarily due to increased clinical trial costs [12][18] - The net loss for Q1 2025 was $15.6 million, an improvement from a net loss of $24.4 million in Q1 2024, with a net loss per share of $0.07 compared to $0.14 in the previous year [12][18][19] Leadership Changes - Jeroen Grasman has been appointed as Chief Financial Officer effective May 19, 2025, succeeding Phillip Lee, who will remain as a non-executive employee until June 1, 2025 [12]

Company Urges Stockholders to Vote FOR Reverse Stock Split Proposal at Upcoming Annual Meeting to Avoid Nasdaq Delisting SOUTH SAN FRANCISCO, Calif., May 12, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today addresses frequently asked stockholder questions regarding a reverse stock split proposal at the Company’s Annual Meeting taking place on Wednesday, May 21, 2025, to regain Nasdaq compliance. 1) Why is Vaxart proposing a reverse stock split? a. Vaxart is at risk of being delisted from Nasdaq si ...

2025Q1疫苗行业跟踪报告（附批签发） 西南证券研究院 2025年5月 分析师：杜向阳 执业证号：S1250520030002 电话：021-68416017 邮箱：duxy@swsc.com.cn 联系人：雷瑞 邮箱：leir@swsc.com.cn 2012.08.13 10287 Hib疫苗：2025Q1批签发7批次(-50%)。 肠道病毒疫苗：2025Q1，EV71疫苗批签发4批次(-69%) 。 数据来源：医药魔方，中检院，西南证券整理，备注：本篇报告括号内均为同比变化数据，后续不一一指出，数据整理截至2025.4.7 1 2025Q1疫苗批签发批次情况 重点疫苗批签发情况： 多联苗：2025Q1，四联苗无批签发，五联苗同比下滑，赛诺菲巴斯德五联苗批签发17批次(+0%)。 肺炎疫苗：2025Q1，肺炎疫苗批累计签发23批次(-30%) ，其中13价肺炎疫苗批签发19批次(+0%)，其中 沃森生物9批次，民海生物6批次，辉瑞4批次。23价肺炎疫苗批签发4批次(-71%)。 HPV疫苗：2025Q1批签发57批次(+63%)。其中双价HPV疫苗批签发42批次（+367%），双价苗需求快速 增长，全部 ...

Total revenues of €49.2 million compared to €32.8 million in the first quarter of 2024Cash and cash equivalents of €153.0 million at end of March 2025Further clinical and regulatory progress2025 financial outlook confirmed Saint-Herblain (France), May 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2025, provided key corporate updates and confirmed its 2025 financial guidance. The condensed co ...

Core Viewpoint - Valneva SE reported strong financial results for Q1 2025, with significant revenue growth and reduced operational cash burn, while confirming its financial guidance for the year [3][5][6]. Financial Performance - Total revenues for Q1 2025 were €49.2 million, a 50.3% increase from €32.8 million in Q1 2024 [5][6]. - Product sales reached €48.6 million, up 51.2% from €32.1 million in the same period last year [6][31]. - The company reported a net loss of €9.2 million compared to a net profit of €58.9 million in Q1 2024, which included €90.8 million from the sale of a Priority Review Voucher [6][45]. - Operating cash burn was reduced by 71% to €8.1 million in Q1 2025 from €28.4 million in Q1 2024 [6][47]. - Cash and cash equivalents stood at €153.0 million as of March 31, 2025, down from €168.3 million at the end of 2024 [6][50]. Product Sales and Market Developments - IXIARO®/JESPECT® sales increased by 65.5% to €27.5 million, driven by demand from travelers and the U.S. Department of Defense [10][32]. - DUKORAL® sales grew 9.4% to €12.3 million, supported by a supply agreement with the French government [12][33]. - IXCHIQ® sales surged to €3.0 million from €0.2 million in Q1 2024, with initial sales related to a chikungunya outbreak response [13][34]. - Third-party product sales increased to €5.8 million from €4.1 million, reflecting recovery from previous supply constraints [18][35]. Research and Development Highlights - Valneva is advancing its Lyme disease vaccine candidate, VLA15, with primary vaccinations completed and data expected by the end of 2025 [20][21]. - The company is also developing a tetravalent Shigella vaccine candidate, S4V2, with ongoing Phase 2 studies [23][24]. - A Phase 1 trial for a Zika vaccine candidate, VLA1601, is currently underway, with results anticipated this year [28][29]. Strategic Partnerships and Regulatory Progress - Valneva secured a $32.8 million supply contract for IXIARO® with the U.S. Department of Defense [7][11]. - The company received marketing authorization for IXCHIQ® in the UK and Brazil, marking significant milestones for its chikungunya vaccine [7][14][15]. - Valneva has entered into a licensing agreement with the Serum Institute of India to expand access to its chikungunya vaccine in Asia [15][61]. Financial Outlook - The company expects product sales to grow to €170-180 million in 2025, with total revenues projected to reach €180-190 million [6][5]. - R&D investments are anticipated to be between €90-100 million in 2025, partially offset by grant funding and tax credits [6][5].

Core Insights - Bavarian Nordic A/S has received an additional contract option from BARDA valued at USD 143.6 million for the supply of freeze-dried JYNNEOS smallpox vaccine [1][10] - The new contract options will support the manufacturing and supply of the freeze-dried formulation, which has an extended shelf life, with deliveries planned for 2026 [2][8] Financial Guidance - Bavarian Nordic's financial guidance for 2025 remains unchanged, projecting total revenues between DKK 5,700 million and DKK 6,700 million, with an EBITDA margin of 26-30% [3] - Revenue from the Public Preparedness business is expected to be between DKK 3,000 million and DKK 4,000 million, with DKK 2,650 million already secured, reflecting an increase of DKK 150 million due to the exercise of the options [3] Product Development and Approval - The freeze-dried formulation of JYNNEOS was approved by the FDA in March 2025, offering advantages in transportation, storage, and shelf life compared to the liquid-frozen version [8] - JYNNEOS is the first smallpox vaccine developed under Project BioShield, which aims to enhance the availability of medical countermeasures against various threats [6] Historical Context - Bavarian Nordic has been collaborating with the U.S. government since 2003 for the development and supply of smallpox vaccines, including the liquid-frozen formulation supplied since 2010 [5][7] - The company has a ten-year contract awarded in 2017, which includes options valued at USD 299 million for the fill and finish of freeze-dried vaccines, of which USD 284 million has been exercised to date [7]