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]

Core Insights - Cosmos Health Inc. reported a revenue increase of 2.0% to $54.43 million for FY 2024, driven by organic growth and contributions from prior acquisitions [5][12] - The company experienced a significant reduction in total operating expenses by 24.16% to $19.86 million, primarily due to cuts in general and administrative expenses and sales and marketing expenses [5][12] - Adjusted EBITDA was negative $3.73 million, a decline from positive $0.06 million in FY 2023, while adjusted net loss widened to $4.74 million from $0.81 million [5][12] Financial Performance - Revenue for FY 2024 was $54.43 million, up from $53.38 million in FY 2023 [5][12] - Gross margin decreased to 7.92% from 8.15% in FY 2023, attributed to a higher revenue mix from lower-margin logistics distribution [5] - Total operating expenses fell to $19.86 million from $26.18 million, with a 40.26% reduction in general and administrative expenses and a 71% decrease in sales and marketing expenses [5][12] Balance Sheet Overview - The liabilities-to-assets ratio was 55% at year-end 2024, indicating a balanced capital structure [3] - Total assets decreased by 17.72% to $54.31 million from $66.01 million at the end of 2023 [5][21] - Total liabilities slightly decreased by 0.64% to $29.78 million as of December 31, 2024 [5][21] R&D and Product Innovation - The company is leveraging AI-driven drug repurposing technologies and is advancing the commercialization of a proprietary weight loss drug [8] - Significant progress was made in securing long-term manufacturing agreements, enhancing revenue visibility [9] - The oncology portfolio was strengthened with the acquisition of two WIPO-patented anticancer drugs valued at over $24.5 million [11] Strategic Developments - The company expanded its nutraceutical brand, Sky Premium Life, with 60 new SKUs and launched the brand in Albania and Qatar [11] - A €2.2 million loan was secured against the CosmoFarm logistics center, providing strategic financial flexibility [10] - CEO Greg Siokas increased personal ownership by over 1 million shares, reflecting confidence in the company's long-term strategy [11]

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]