Axsome Therapeutics (AXSM) 2025 Conference Summary Company Overview - Axsome Therapeutics is a CNS-focused biopharmaceutical company with three commercial programs: - **Avelity** for major depressive disorder (MDD) - **Sunosi** for excessive daytime sleepiness associated with obstructive sleep apnea (OSA) and narcolepsy - **Simbravo** for migraine, which is set to launch imminently [5][8][4] Key Programs and Developments - **Commercial Programs**: - Avelity has an annualized run rate of **$400 million** as of Q1 2025, with **15%** frontline use and **35%** second-line use among scripts [16][17] - Sunosi has approximately **75 sales reps**, while Avelity has expanded to **300 reps** from **260** earlier in the year [11][12] - Simbravo will launch with **100 reps** focused on headache centers [14][38] - **NDA Stage Programs**: - AXS-05 for Alzheimer's disease agitation - AXS-14 for fibromyalgia - AXS-12 for narcolepsy [6][8] Financial Outlook - Axsome expects to reach cash flow positivity but has not specified a timeline [8] - The company is focused on disciplined capital deployment and efficient launches due to high synergy within its sales teams [9][8] Market Strategy and Growth Drivers - Axsome plans to increase engagement with primary care physicians, which currently account for **20-25%** of scripts for Avelity [22] - A national direct-to-consumer (DTC) campaign is in development, with testing in regional markets [23][24] - The company anticipates improvements in coverage and access for patients, which could drive volume [24] Product Differentiation and Competitive Landscape - Avelity is positioned as a potential multi-billion dollar opportunity in MDD, with a unique profile compared to competitors like Rexulti and Vraylar [16][18] - The product is expected to have a distinct label and safety profile, differentiating it from atypical antipsychotics [30][32] Upcoming Approvals and Pipeline - Axsome is preparing to file an sNDA for Avelity in Q3 2025 for Alzheimer's agitation [27][35] - The company is also working on NDA submissions for AXS-14 (fibromyalgia) and AXS-12 (narcolepsy) [49][46] Clinical Data and Efficacy - AXS-14 has shown potential in addressing fatigue, a significant symptom for fibromyalgia patients, which may differentiate it from existing treatments [52] - The FOCUS Phase III trial for Sunosi in adults was positive, and a pediatric trial is planned to complete the NDA package [59] Conclusion - Axsome Therapeutics is strategically positioned for growth with multiple product launches and a robust pipeline. The focus on CNS disorders, combined with a disciplined approach to capital and market engagement, suggests a promising outlook for the company in the coming years [5][8][24]

Summary of Conference Call Company Overview - **Company**: MannKind Corporation - **Core Product**: Afrezza, an inhaled insulin product - **Key Partnerships**: United Therapeutics Key Points and Arguments Financial Performance - MannKind has reduced its debt significantly, paying down over $250 million, leaving $35 million remaining on the balance sheet [3] - The company reported a 20% growth in new prescriptions (NRx) for diabetes in Q1 [4] - Cash equivalents stood at nearly $200 million [6] - Revenue growth year-over-year was 18%, with royalties up 32% [37] Product Development and Pipeline - **Afrezza**: - Expected label change in Q4, which is anticipated to drive growth [5] - Pediatric data submission to the FDA is planned for late June to early July, with hopes for approval next year [5][9] - The company is focusing on expanding Afrezza's use in gestational diabetes, with ongoing studies and published data [10][19] - The company aims to achieve a run rate of $203 million for Afrezza sales in the near term [20] - **Tyvaso DPI**: - Licensed to United Therapeutics, showing strong year-over-year growth [20] - Anticipated readout from the TETON-two study in the second half of the year [21] - **Clofazamine**: - Enrollment targets for the trial are ahead of schedule, with a focus on non-tuberculous mycobacterial (NTM) disease [6][24] - The inhaled formulation aims to mitigate risks associated with the oral version of the drug [25] - **02/2001 (IPF Asset)**: - Development is ongoing, with plans to initiate a Phase 2 study [33][34] Market Dynamics - The inhaled insulin market is becoming competitive with insulin pumps, but Afrezza offers unique advantages such as fixed dosing without the need for carb counting [8][9] - The pediatric market is seen as a pivotal opportunity for growth, with a focus on improving A1C levels in children with diabetes [44][45] Strategic Outlook - The company is optimistic about its growth trajectory, with multiple label changes and product approvals expected in the coming year [42] - MannKind is positioning itself to capture a significant share of the diabetes market, particularly among children and pregnant women [44][45] - The company anticipates that every 10% market share in pediatrics could yield approximately $150 million in net revenue [44] Risks and Considerations - The company acknowledges the challenges in scaling Afrezza's growth and the need for effective marketing strategies to overcome competition [4][39] - There are concerns regarding the variability in trial results and the need for proper dosing to achieve better control for patients [18] Additional Important Information - MannKind has a strong focus on improving patient outcomes and providing alternatives to traditional insulin delivery methods [12][19] - The company is actively engaging with the FDA and other stakeholders to ensure successful product development and market entry [5][42] - The potential market for NTM is estimated to be a billion-dollar market, with significant unmet needs [22][23]

Summary of the Conference Call Company and Industry - **Company**: Atomic Therapeutics - **Industry**: Biotechnology, specifically focusing on oncology and cancer treatment Key Points and Arguments 1. **Introduction of APKAN ADC**: Atomic Therapeutics presented data on CX-2051, a Probody ADC targeting EpCAM, which shows potential in treating metastatic colorectal cancer (CRC) and other cancer types [4][5] 2. **Clinical Data Highlights**: - 25 patients treated with a confirmed overall response rate (ORR) of 28% across 18 efficacy evaluable patients, with a 43% ORR at the highest dose of 10 mg/kg [9] - Median progression-free survival (PFS) of 5.8 months, significantly higher than the current standard of care [10] - Disease control rate of 94% across all measures [10] 3. **Safety Profile**: - The drug demonstrated minimal on-target toxicity, which is a significant concern with EpCAM-targeting therapies due to its expression in normal tissues [12][14] - Anticipated payload toxicities were manageable, with low rates of cytopenias and moderate gastrointestinal toxicity [15][17] 4. **Expansion of Clinical Trials**: Plans to expand patient cohorts at dose levels 7.2, 8.6, and 10 mg/kg to 20 patients each by the end of the year, with a dataset expected in Q1 2026 [21][22] 5. **Regulatory Strategy**: The company aims for accelerated approval in late-line metastatic CRC, with ambitions to move into earlier treatment lines [24][25][28] 6. **Market Opportunity**: - The fourth-line CRC market is estimated to have around 15,000 treatable patients annually in the U.S., with significant revenue potential demonstrated by Fruquintinib's sales [35] - The overall market for metastatic CRC across multiple lines of treatment is approximately 150,000 patients [37] 7. **Future Development Plans**: - The company is considering combination studies with bevacizumab and exploring opportunities in other solid tumors beyond CRC [40][42] - A second drug, CX-801, is in Phase 1 trials, focusing on melanoma in combination with PD-1 inhibitors [45][48] 8. **Financial Position**: The company recently completed a financing round, providing a cash runway into Q2 2027, ensuring funding for ongoing clinical trials [52] Other Important Content - **Technological Innovation**: The Probody masking platform is highlighted as a key differentiator, allowing for targeted therapy with reduced toxicity [12][14] - **Investor Interest**: Positive investor feedback has been noted following the data release, indicating strong market confidence in the drug's potential [10][11] - **Long-term Vision**: The company envisions CX-2051 as a disruptive treatment option that could replace systemic chemotherapy in earlier lines of CRC treatment [26][30]

Summary of Arvinas (ARVN) Conference Call Company Overview - Arvinas is focused on protein degradation and was founded in 2013 by Craig Kruse at Yale University, being the first company in this space [1][2] - The company has achieved several milestones, including being the first to obtain INDs, enter phase one and phase two trials, and complete pivotal trials with positive data for ProTAC technology [2][3] Core Technology and Benefits - Protein degradation technology allows for the elimination of targeted proteins through the cell's natural degradation system, offering advantages over traditional inhibitors [3][4] - ProTACs are catalytic, allowing for multiple rounds of degradation, and are orally bioavailable with broad tissue distribution [4][5] - The technology shows promise in oncology by overcoming resistance mechanisms and targeting previously undruggable targets [5][6] Current Portfolio and Collaborations - The primary focus is on Vebdegastrant (ER degrader) in partnership with Pfizer, with pivotal trial data recently presented at ASCO [7][9] - Other programs include ARV393 (BCL6 degrader), ARV102 (LARC2 degrader), and ARV806 (KRAS G12D degrader), with several in various stages of clinical trials [8][12] - The company has a strong capital position with nearly $1 billion in cash, providing a runway into the second half of 2028 [12] Clinical Data and Future Plans - Vebdegastrant showed a median progression-free survival (PFS) of 5 months in the ESR1 mutant group, outperforming fulvestrant by 2.9 months [9][10] - The NDA submission for Vebdegastrant is imminent, with plans for a potential launch in 2026 [11][12] - Upcoming data releases include results from the SCD cohort and initial phase one data for ARV393 and ARV806 [11][12] Strategic Considerations and Market Position - The partnership with Pfizer is under review, with discussions on potential changes to the collaboration structure due to evolving market conditions [13][14] - There is a belief that Vebdegastrant has opportunities in both second-line and first-line settings, although Pfizer has expressed hesitance to pursue first-line development [15][16] - The market for second-line treatments is estimated to be significantly larger than current figures, with potential sales for Vebdegastrant projected in the range of $500 million to $700 million [24][68] Investor Insights and Future Catalysts - The company is focused on balancing the potential of Vebdegastrant with other promising assets in its pipeline, including LARC2 and KRAS G12D [48][64] - Key inflection points for upcoming clinical data are expected by the end of 2026, with interim data available along the way [75][79] - The company aims to maintain a strong cash position while exploring strategic partnerships or licensing opportunities for its assets [52][84] Conclusion - Arvinas is positioned as a leader in the protein degradation space with a robust pipeline and strategic partnerships, while navigating challenges in collaboration and market dynamics. The upcoming clinical data and potential NDA submissions are critical for the company's future growth and investor confidence.

Summary of Nasdaq (NDAQ) Conference Call - June 05, 2025 Company Overview - **Company**: Nasdaq, Inc. - **Industry**: Global exchange operator and financial technology company Key Points Economic Environment and IPO Market - The U.S. economy shows strength and resilience, which supports capital deployment by companies and investors [5][6] - The IPO pipeline is expected to open up as volatility moderates, with companies preparing to enter public markets [5][6] - There is pent-up supply from companies ready to go public, indicating optimism for increased IPO activity in the summer and second half of the year [6] Sector Engagement - High engagement is noted in sectors related to AI technology and financial services, particularly fintech [7] - Companies in the digital economy are more attractive to investors compared to those affected by tariff uncertainties [8] Sales Cycle and Demand for Financial Technology - Demand for Nasdaq's financial technology solutions remains strong, with normalized conversations following tariff volatility [10] - The company is well-positioned competitively, with a healthy demand orientation for its products [10] One Nasdaq Strategy - Progress is being made towards the goal of $100 million in cross-selling opportunities by 2027, with 15% of the fintech pipeline currently in cross-sells [11][12] - The strategy involves aligning teams, tracking client data, and engaging clients holistically [11] Product Demand and Market Modernization - Strong demand across all product vectors, including surveillance and market modernization solutions [15] - New regulations and the need for modernization in risk management are driving demand for Nasdaq's products [15][16] Crypto and Tokenization Opportunities - Nasdaq is actively providing trading and clearing technology for crypto markets, with growth potential as cryptocurrencies become more bankable [19] - The company aims to leverage its technology to reduce friction in the financial system through tokenization [20] Index Business Performance - The index business has shown strong revenue growth, with a focus on transparency and alpha generation [22] - New product launches and global expansion are key growth drivers [24] 24/5 Trading Initiative - Nasdaq is exploring the implementation of 24/5 trading to meet global retail demand, while ensuring investor protections are in place [26][27] - The company is working on building the necessary infrastructure and regulatory approvals for this initiative [29][30] Texas as a Capital Markets Hub - Texas is emerging as a significant capital markets hub, with Nasdaq planning to establish a regional headquarters in Dallas [32][34] - The pro-business environment and the state's efforts to create a capital markets hub present growth opportunities for Nasdaq [34][36] M&A Strategy - Nasdaq is focused on organic growth and deleveraging, with no immediate plans for large-scale M&A [40][41] - The company is open to small bolt-on acquisitions but prioritizes optimizing organic growth [41] Artificial Intelligence Integration - Nasdaq is implementing AI in product development and business operations, with a focus on enhancing efficiency and client service [42][43] - The company anticipates that AI will support margin expansion over time [48] Future Trends in the Exchange Business - Major trends identified include AI, tokenization, and the potential for 24/5 trading, with Nasdaq committed to being an innovator in these areas [50][51] Additional Insights - Nasdaq's engagement with clients in Texas and the broader regulatory environment is crucial for future growth [36] - The company is actively working on corporate reforms to improve the public company experience in the U.S. [36]

Jamf (JAMF) 2025 Conference Summary Company Overview - Jamf is a 22-23 year old company originally focused on managing education devices, specifically Macs in the education sector. Currently, approximately 25% of its Annual Recurring Revenue (ARR) comes from education, with the remainder from commercial sectors [6][8]. - The company has expanded into the security space, with security now contributing about $160 million to ARR, showing significant growth [7]. Key Developments - Jamf has made strategic acquisitions, including Wandera in 2021, which enhanced its security offerings, and Identity Automation, acquired on April 1, 2025, marking its entry into identity management [6][8][31]. - The company has launched a combined management and security platform, offering products like Jamf for Mac, Jamf for mobile, and Jamf for K-12 [8][17]. Market Position and Strategy - Jamf operates in approximately 20 countries, with 85% of its international revenues generated through channel sales. In the U.S., about 55% of revenues come from channel sales [8]. - The company is focusing on mixed device environments, supporting both Apple and Android devices, which is expected to enhance its competitive position [12][37]. Sales Pipeline and Trends - The sales pipeline is increasingly driven by combined product offerings, leading to lower churn rates and higher adoption among customers [16][17]. - Mobile solutions are identified as a significant growth opportunity, particularly in sectors like transportation, healthcare, and retail [19][20]. Financial Guidance and Market Conditions - The company has noted an uncertain macroeconomic environment, with recent layoffs impacting overall demand. However, Q4 was strong, and the company maintained its full-year guidance despite some deal cancellations and delays [23][25][27]. - Net Revenue Retention (NRR) has stabilized around 104, with expectations for improvement as the security business grows [28][29]. International Growth Potential - Jamf has seen strong traction in international markets, particularly in APAC and EMEA, with expectations for continued growth driven by its core management products and security add-ons [48][49]. - The company is prioritizing regions with increasing Apple adoption, such as EMEA, while also exploring new markets [51]. Margin Expansion and Capital Allocation - Operating margin guidance for the year is set at 21%, with a goal of achieving a "rule of 40" run rate by the end of fiscal 2026 [55][56]. - The company plans to utilize its term loan and cash reserves for strategic investments, including paying down debt and funding acquisitions [62][63]. Pricing Strategy - Jamf has been cautious with price increases, focusing on providing value while embedding reasonable annual price increases in new platform products [60][61]. Conclusion - Jamf is positioned for growth through strategic acquisitions, a focus on mixed device management, and expanding its international presence. The company is navigating a dynamic market environment while maintaining a strong emphasis on security and identity management solutions.

Summary of Zeta Global Conference Call Company Overview - **Zeta Global** is a marketing technology company focused on helping mid-market to large enterprises acquire, grow, and retain customers, primarily in consumer-facing sectors [3][4][6]. Core Business Model - Zeta Global emphasizes **identity-based marketing** on the open web, differentiating itself from traditional platforms like Facebook and Google, which operate within closed ecosystems [5][6]. - The company claims to reach about **90% of the US adult population** monthly, allowing it to synthesize consumer intent and identity effectively [6][7]. Market Demand and Performance - Despite concerns about unstable macroeconomic conditions, Zeta Global reports strong demand, with **April being one of their strongest months** and the signing of three of their largest contracts in history within the last 90 days [11][12]. - Consumer behavior remains stable, with demand in sectors like retail reportedly increasing [11][14]. Data Assets and Compliance - Zeta Global operates two major data networks: **Disqus**, a commenting platform, and **LiveIntent**, an ad exchange for publishers [22][23]. - The company emphasizes compliance with regulations, particularly in highly regulated industries like banking and telecom, and has taken steps to improve transparency with investors [20][21]. Data Strategy - Zeta Global's data strategy includes a **mature identity graph** representing approximately **200 to 245 million individuals** in the US, which is crucial for understanding consumer behavior [25][26]. - The company plans to expand its data assets and geographic reach, particularly in Western Europe and Latin America [31][32]. AI and Technology Integration - Zeta Global is leveraging **AI** to enhance marketing automation and customer engagement, with tools like **Compass** designed to reduce onboarding time significantly [52][54]. - The company has introduced the **Answers Framework**, which integrates intelligence and action, making it easier for marketers to interpret data and take action [56][58]. Competitive Landscape - Zeta Global believes that traditional marketing clouds have lost focus, allowing them to grow faster than competitors like Salesforce, which reported only **4% growth** in their marketing cloud [69]. - The company asserts that replicating their data asset and operational model is challenging due to the scale and integration required [71][73]. Future Focus - Zeta Global's key investment priority is to enhance **outcomes** for customers through generative capabilities that improve ROI, rather than solely differentiating on the data side [74]. Conclusion - Zeta Global is positioned as a leader in the marketing technology space, leveraging a unique data strategy and AI capabilities to drive customer acquisition, growth, and retention while navigating a complex macroeconomic environment.

Amphastar Pharmaceuticals Conference Call Summary Company Overview - Amphastar Pharmaceuticals is a biopharmaceutical company focused on injectable and inhalation products, emphasizing complex generic injectables and proprietary products [4][5] - Key products include Primatene Mist, the only OTC FDA-approved asthma medication, and Baqsimi, a nasal glucagon product acquired from Eli Lilly [5] Financial Performance - The company anticipates flat revenues for the year, with slight declines in earnings due to increased competition affecting gross margins on key products [7] - A significant increase in R&D budget is noted as the company explores more complex generic products and proprietary offerings [7] - The goal is to return to double-digit sales growth in the following year [8] Product Insights Baqsimi - Baqsimi is a major growth driver, with growth attributed to increased awareness and feasibility among insulin-prescribing patients [9] - Currently, only about 12% of insulin patients have glucagon on hand, indicating significant room for growth [10][11] - The product's ease of use compared to traditional glucagon kits is highlighted as a competitive advantage [15][19] - Baqsimi is expected to see high single-digit growth for the year, with a price increase of 3% in the U.S. contributing to overall sales growth [22][28] Primatene Mist - Primatene Mist is projected to grow by high single digits this year, supported by national media coverage and expanded marketing efforts targeting primary care physicians [30][31] - The company is piloting a small sales force to enhance brand growth, with plans to evaluate its success in 2026 [32][35] Competitive Landscape - Baqsimi is the leading prescribed glucagon in the U.S., outperforming competitors like Gvoke due to its intranasal delivery method, which is preferred by caregivers [18][20] - The company is optimistic about maintaining its market position and continuing to grow its share [16][19] Pipeline and Future Growth - Amphastar has four ANDAs under FDA review, with expectations to receive approvals for two products by year-end [39] - The pipeline includes complex generics and an inhalation product, which is seen as promising due to the lack of existing generics in the market [53][56] - The company anticipates peak sales for Baqsimi in the range of $250 million to $275 million over the next several years [26] Manufacturing and Tariff Exposure - All finished products are manufactured in the U.S., with some active ingredients sourced from China and France [63] - The company estimates a quarterly impact of approximately $500,000 due to tariffs on certain APIs, but this is not considered material [64] R&D Strategy - Amphastar's strategy focuses on internal R&D, leveraging the expertise of its scientific founders [69] - The company is open to future acquisitions that align with its manufacturing capabilities and product focus, particularly in the endocrinology space [70]

Summary of Lexio Therapeutics Conference Call Company Overview - **Company**: Lexio Therapeutics - **Industry**: Biotech, specifically focusing on cardiac genetic medicine - **Key Programs**: - Friedreich's ataxia (FA) cardiomyopathy - Radiogenic cardiomyopathy targeting PKD2 mutation Core Points and Arguments 1. **Clinical Stage and Focus**: Lexio is a clinical-stage company with two advanced cardiovascular therapy programs, primarily targeting the cardiac pathology of Friedreich's ataxia, which is associated with cardiomyopathy as a leading cause of death [3][4] 2. **Enrollment and Progress**: The company has completed enrollment for a Phase 1/2 study and is moving towards a registrational study, with data readouts expected in the second half of the year [5][6] 3. **Market Opportunity**: The PKD2 mutation affects over 50,000 patients in the U.S., presenting a significant commercial opportunity, larger than Duchenne muscular dystrophy [5] 4. **Safety Profile**: Lexio emphasizes a strong safety profile for its gene therapy, utilizing lower doses to minimize adverse effects, with no substantial safety issues reported at the doses used [11][12][15] 5. **Efficacy Data**: - In the FA cardiomyopathy program, a 25% reduction in left ventricular mass was observed, alongside a 60% reduction in troponin levels, indicating a meaningful impact on cardiac health [18][19] - Improvements were also noted in neurologic scales, suggesting broader benefits beyond cardiac symptoms [20][21] 6. **Regulatory Alignment**: The company has reached alignment with the FDA on the accelerated approval path and is finalizing the statistical analysis plan for the registrational study [27][29] 7. **Future Plans**: Lexio plans to start the registrational study by early 2026, with a focus on expanding patient cohorts and ensuring robust data collection [32][34] Additional Important Insights 1. **Market Interest**: There is significant interest in therapies targeting the cardiac manifestations of Friedreich's ataxia, as addressing cardiomyopathy is crucial for improving patient mortality [45][46] 2. **Broader Impact**: The therapy appears to address multiple aspects of Friedreich's ataxia, not just cardiac symptoms, which may enhance its appeal to both cardiologists and neurologists [40][41] 3. **Regulatory Engagement**: Lexio has maintained positive engagement with the FDA, with no significant changes in collaboration despite broader industry challenges [56][57] 4. **Alzheimer's Program**: Lexio is also exploring a program for homozygous Alzheimer's disease, showing promise in reducing tau biomarkers without significant risks [91][93] Conclusion Lexio Therapeutics is positioned to make significant advancements in the treatment of cardiac genetic diseases, particularly Friedreich's ataxia and radiogenic cardiomyopathy, with a strong focus on safety and efficacy. The upcoming registrational study and positive regulatory engagement are critical steps towards potential market approval and addressing unmet medical needs in these patient populations.

Summary of Vaxart Conference Call Company Overview - **Company**: Vaxart - **Industry**: Vaccine Development - **Key Products**: Oral vaccines, including those for COVID-19 and norovirus Core Points and Arguments 1. **Unique Oral Vaccine Platform**: Vaxart is developing an oral vaccine that can be self-administered, contrasting with traditional injected vaccines which require appointments and can have side effects [2][3][4] 2. **Scientific Advantages**: The oral vaccine elicits both systemic immune responses (IgG) and mucosal immune responses (dimeric IgA), which may provide better protection against variant strains [5][6][31] 3. **Health Economic Benefits**: The oral vaccine eliminates the need for cold chain storage and reduces medical waste, potentially lowering overall healthcare costs [8][10] 4. **COVID-19 Program**: Vaxart received over $450 million in funding from BARDA for a study comparing its oral vaccine to an mRNA vaccine, with a 10,000 participant study currently underway [11][12][33] 5. **Study Design**: The study includes both symptomatic and asymptomatic COVID-19 infection tracking, with a follow-up period of 12 months [15][16][19] 6. **Funding Structure**: The funding agreement is milestone-driven, with $240 million immediately available to support the study [33][34] 7. **Norovirus Vaccine Development**: Norovirus causes significant health issues, particularly in vulnerable populations, and Vaxart aims to develop a vaccine targeting this virus, with no approved vaccines currently available [41][42] 8. **Second Generation Norovirus Vaccine**: Vaxart is advancing a second-generation vaccine with improved immunogenicity and manufacturing efficiency, with data expected mid-year [44][46][49] 9. **Market Potential**: The financial impact of norovirus in the U.S. is estimated at $10 billion annually, indicating a significant market opportunity for a vaccine [41] 10. **Partnership Opportunities**: Vaxart is in discussions with various companies for potential partnerships to support its vaccine programs, particularly for norovirus [72][73] 11. **Influenza Programs**: Vaxart is also developing vaccines for seasonal and pandemic influenza, with promising preclinical results [66][68] Other Important Content - **Regulatory Environment**: The company has maintained a good relationship with the U.S. government, which has allowed it to proceed with its studies without major changes [12][36] - **Safety Monitoring**: An independent Data Safety Monitoring Board has recommended proceeding with the study without modifications, indicating confidence in the study's design [25][26] - **Cross-Reactivity and Viral Shedding**: The oral vaccine shows potential for cross-reactivity against various strains and may reduce viral shedding, which is critical for controlling pandemics [31][32][60] - **Runway and Future Funding**: Vaxart's current financial runway extends into the first quarter of the following year, with plans to seek additional funding based on positive study results [74][75]