Vaxart (VXRT) 2025 Conference June 05, 2025 02:00 PM ET Speaker0 Good afternoon, everyone. Thanks for coming for the last day of the Jefferies Healthcare Conference. Last but not least, we have Vexard with us today. Together with me is a CEO, mister Steve Lowe, and also CMO, James Cumming. Alright. So, Steve, I know you have a very unique platform oral vaccine. So maybe we can start with some, like, high level introduction on your platform, and that'll be very helpful. Speaker1 Sure. That's that's great. We ...

Core Insights - Valneva SE announced positive six-month antibody persistence and safety data for its Phase 2 clinical trial of the chikungunya vaccine IXCHIQ in children, supporting the initiation of a pivotal Phase 3 study in early 2026 [1][2][8] Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, with a strong track record in advancing multiple vaccines from early R&D to approvals [10][11] - The company currently markets three proprietary travel vaccines, including the world's first and only chikungunya vaccine, and has a pipeline that includes candidates for Lyme disease, Shigella, and Zika virus [12] Clinical Trial Results - The Phase 2 trial (VLA1553-221) involved 304 healthy children aged one to eleven years, demonstrating that a full dose of the vaccine elicited a more robust immune response compared to a half dose, with a 96.5% seroresponse rate at Day 180 [2][3][8] - The vaccine was well tolerated across all age groups tested, with no safety concerns identified, supporting the selection of the full dose for the upcoming Phase 3 trial [4][5][8] Market Context - Chikungunya poses a significant health risk, particularly in endemic areas, with Brazil reporting over one million cases from January 2019 to July 2024, and India reporting 370,000 cases during the same period [5][7] - The World Health Organization has identified chikungunya as a major public health problem, with the economic impact expected to grow due to climate change and the geographical spread of mosquito vectors [7]

Core Viewpoint - Vaxart, Inc. is urging stockholders to vote in favor of a reverse stock split proposal to regain compliance with Nasdaq's minimum bid price rule by the deadline of June 1, 2025 [1][2] Group 1: Reverse Stock Split Proposal - Dr. Sean Tucker, Founder and CSO of Vaxart, emphasizes the importance of voting FOR Proposal No. 2, which would allow the Board of Directors to implement a reverse stock split [1] - The company has provided a fact sheet to clarify misconceptions regarding the reverse stock split proposal [2] - Stockholders who have not yet voted are encouraged to do so by the deadline, and those who previously voted against the proposal can change their vote [2] Group 2: Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [4] - The company's vaccines are designed to be administered in pill form, which can be stored and shipped without refrigeration, thus eliminating the risk of needle-stick injury [4] - Current development programs include vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [4]

- Study will assess relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA comparator at 12 months - SOUTH SAN FRANCISCO, Calif., May 27, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced the first patient was dosed in the 10,000-participant portion of its ongoing Phase 2b clinical trial evaluating its oral pill COVID-19 vaccine candidate. “Initiating dosing in the 10,000-participant portion of this study is a significant st ...

Core Insights - Evaxion A/S is progressing well with its strategy, achieving key milestones and focusing on the execution of its clinical trials and collaborations [2][4][11] - The company is advancing its AI-Immunology™ platform and pipeline, with a focus on personalized cancer vaccines and infectious disease candidates [3][10][31] Business Highlights - The company has achieved the first two milestones for 2025, including the ongoing phase 2 trial of EVX-01 for advanced melanoma, which is expected to yield two-year data in the second half of 2025 [2][4] - Collaboration with MSD on EVX-B2 and EVX-B3 is on track for potential option exercise, which could lead to significant milestone payments and royalties for Evaxion [11][12] Research & Development Update - The phase 2 trial of EVX-01 has shown promising results, with 80% of vaccine targets triggering a tumor-specific immune response, an increase from previous hit rates of 71% and 79% [5][7] - The company is also developing a precision vaccine targeting non-conventional endogenous retrovirus (ERV) tumor antigens, with plans to select a lead candidate in 2025 [7][9] Financial Overview - As of March 31, 2025, cash and cash equivalents were $17.8 million, a significant increase from $6.0 million at the end of 2024, providing a cash runway until mid-2026 [17][27] - The company reported a net loss of $1.6 million for the first quarter of 2025, compared to a net income of $1.2 million for the same period in 2024, primarily due to changes in financial income [22][30] Equity and Liabilities - Total equity improved to $10.3 million as of March 31, 2025, compared to a negative equity of $(1.7) million at the end of 2024, reflecting the company's strengthened financial position [23][27] - The company is in the process of converting €3.5 million of its €7 million loan from the European Investment Bank into an equity-type instrument, expected to enhance financial flexibility [15][16]

Saint-Herblain (France), May 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and hold investor meetings at several upcoming investor conferences in the United States and Europe in June 2025. Key topics for discussion include Valneva’s commercial stage vaccines and its differentiated portfolio of vaccine candidates, including VLA15, the world’s leading Lyme disease vaccine candidate. VLA15 is partnered with Pfize ...

Company Overview - Evaxion A/S is a clinical-stage TechBio company that specializes in developing AI-Immunology™ powered vaccines [4] - The company utilizes proprietary AI prediction models to decode the human immune system and create novel immunotherapies for cancer, bacterial diseases, and viral infections [4] - Evaxion has a clinical-stage oncology pipeline of personalized vaccines and a preclinical pipeline targeting infectious diseases with high unmet medical needs [4] Upcoming Events - Evaxion will provide a business update and report its first quarter 2025 financial results on May 27, 2025, before the opening of Nasdaq CM [1] - The Executive Management will host a conference call and webcast on the same day at 14:30 CET/08:30 EST, which is free and open to the public [2] - Participants can register in advance to receive dial-in numbers and a unique PIN code for the conference call [2] Communication and Contact - Mads Kronborg is the Vice President of Investor Relations & Communication at Evaxion, and can be contacted at +45 53 54 82 96 or via email at mak@evaxion.ai [4]

Core Viewpoint - Evaxion A/S has initiated a one-year extension of its ongoing phase 2 trial for its personalized cancer vaccine EVX-01, aimed at treating advanced melanoma, leveraging its AI-Immunology™ platform to explore the vaccine's long-term clinical and immune benefits [1][2][4]. Group 1: Trial Details - The first patient has been dosed in the one-year extension of the trial, which will involve two additional doses of EVX-01 as monotherapy [3]. - The initial two years of the trial involved EVX-01 in combination with standard anti-PD-1 therapy, and the extension phase allows for evaluation of EVX-01 as a standalone treatment [4][5]. - The trial extension incurs minimal costs since trial sites are already operational and the vaccine has been produced [2][10]. Group 2: Clinical Data and Results - Interim one-year data presented at the ESMO Congress in September 2024 showed a 69% Overall Response Rate, with tumor target lesions reduced in 15 out of 16 patients [8]. - At the AACR Annual Meeting in April 2025, it was reported that 80% of EVX-01's vaccine targets triggered a targeted immune response, indicating favorable outcomes compared to other treatment approaches [9]. - The completed phase 1/2a clinical trial demonstrated that 67% of metastatic melanoma patients had objective clinical responses, highlighting the predictive power of the AI-Immunology™ platform [12]. Group 3: Product and Technology Overview - EVX-01 is a personalized peptide-based cancer vaccine designed to engage the patient's immune system against tumors, tailored to each individual's unique tumor profile [6][11]. - The AI-Immunology™ platform is central to Evaxion's approach, enabling the development of novel immunotherapies for various diseases, including cancer [13].

Meeting adjourned to June 2, 2025 at 8:30 a.m. Pacific Time Vaxart encourages all stockholders of record on March 26, 2025 who have not yet voted to do so by 11:59 p.m. Eastern Time on June 1, 2025 SOUTH SAN FRANCISCO, Calif., May 21, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) (“Vaxart” or the “Company”) announced today that its 2025 annual meeting of stockholders (the “Annual Meeting”) has been adjourned to Monday, June 2, 2025 at 8:30 a.m. Pacific Time with respect to all proposals described in ...

Company Urges Stockholders to Vote ‘FOR’ Reverse Stock Split Proposal at Upcoming Annual Meeting to Avoid Nasdaq Delisting Leading Independent Proxy Advisory Firms, ISS and Glass Lewis, Support Proposal #2 SOUTH SAN FRANCISCO, Calif., May 16, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it has filed a supplement to its proxy statement for its Annual Meeting. The board of directors approved the following two items, if Proposal #2 passes: The current authorized number of shares of ...