Financial Data and Key Metrics Changes - For the fiscal year ended 03/31/2025, the company reported a 220% increase in revenue to $3,700,000 compared to $1,200,000 for the same period last year [5][19] - The company anticipates revenue of at least $1,700,000 for the quarter ending 06/30/2025, representing greater than 45% sequential quarterly growth and greater than 145% year-over-year growth [6] - Revenue guidance for the full fiscal year ending 03/31/2026 is projected to be between $12,000,000 and $16,000,000 [6][21] - The net loss attributed to common stockholders for the fiscal year was $46,600,000, or a loss of $0.69 per share, compared to a net loss of $60,200,000, or a loss of $1.82 per share, for the previous fiscal year [21] Business Line Data and Key Metrics Changes - The commercial team secured three new hospital contracts and renewed three contracts during the fourth quarter [8] - The company has established a solid customer base across key target regions in the US, with 45 hospitals either installed or using the LungFit system [68] Market Data and Key Metrics Changes - The company has ramped up its commercial program across Europe, Southeast Asia, and the Middle East, securing key regulatory approvals and signing distribution agreements covering over 2,000,000,000 lives [11] - Initial shipments of LungFit PH to international customers have begun, with expectations for meaningful contributions to financial results starting in the latter half of fiscal 2026 [12] Company Strategy and Development Direction - The company aims to make LungFit PH the market leader in the nitric oxide market, overcoming barriers to entry and enhancing customer confidence through increased usage [7] - The introduction of LungFit PH2, a next-generation system, is expected to significantly impact market share and logistics within hospitals [10] - The company is focused on cost reduction efforts, having reduced operating expenses from over $17,000,000 to just above $7,000,000 in the current quarter, translating to a 58% reduction [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue targets for the upcoming quarter and fiscal year, citing strong customer interest and flexibility in contract structures [66] - The company is optimistic about the potential for international growth, although it acknowledges the longer tender processes outside the US [31][59] Other Important Information - The company received orphan drug designation from the FDA for its lead investigational therapy BA102, which is being developed for the treatment of Phelan McDermott syndrome [13] - The company announced the appointment of Bob Goodman to the board of directors, bringing extensive commercial leadership experience [16] Q&A Session Summary Question: Is the approval of LungFit 2.0 included in the fiscal year 2026 guidance? - Management confirmed that the fiscal year 2026 guidance does not include the second-generation system [28] Question: What are the dynamics of international contracts and usage compared to US hospitals? - Management indicated that initial shipments are for demonstration purposes, and the tender process outside the US takes longer [31] Question: What is the expected timeline for FDA approval of LungFit 2.0? - Management refrained from providing a specific timeline, noting the current upheaval at the FDA [40] Question: What factors could lead to achieving the higher end of the revenue guidance range? - Management mentioned that securing large contracts and regulatory approvals could significantly impact revenue [42] Question: How is the company addressing potential geopolitical impacts on supply and sales? - Management stated that the majority of manufacturing is in the US, and geopolitical issues have minimal impact on costs [53] Question: How does LungFit 2.0 expand the market? - Management noted that the new system would allow access to every hospital wanting to use nitric oxide, significantly increasing market reach [82]

Financial Data and Key Metrics Changes - For the fiscal year ended 03/31/2025, the company reported a 220% increase in revenue to $3.7 million compared to $1.2 million for the same period last year [5][19] - The company anticipates revenue of at least $1.7 million for the quarter ending 06/30/2025, representing greater than 45% sequential quarterly growth and greater than 145% year-over-year growth [6] - Revenue guidance for the full fiscal year ending 03/31/2026 is projected to be between $12 million and $16 million [6][21] - The net loss attributed to common stockholders was $46.6 million, or a loss of $0.69 per share, compared to a net loss of $60.2 million, or a loss of $1.82 per share, for the previous fiscal year [21] Business Line Data and Key Metrics Changes - The commercial team secured three new hospital contracts and renewed three contracts during the fourth quarter [7] - The company has established a solid customer base across key target regions in the U.S. [7] - The company has shipped more than a dozen units of LungFit PH to customers outside the U.S. recently, with expectations for meaningful contributions to financial results starting in the back half of fiscal 2026 [12] Market Data and Key Metrics Changes - The company has ramped up its commercial program across Europe, Southeast Asia, and the Middle East, securing key regulatory approvals and signing distribution agreements covering over 2 billion lives [11] - The company has signed several new international distribution partnerships in countries including India, Italy, and Ukraine [11] Company Strategy and Development Direction - The company aims to make LungFit PH the market leader in the nitric oxide market by overcoming barriers to entry and enhancing customer confidence through increased usage [6] - The company is focused on reducing operating expenses and cash burn while preparing for the launch of its next-generation LungFit PH2 system [22] - The collaboration with Vanderbilt University Medical Center is intended to optimize LungFit products and enhance hospital-based nitric oxide therapy [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue targets and highlighted the potential for significant growth driven by new contracts and international expansion [6][66] - The company is optimistic about the upcoming FDA approval of LungFit PH2, which is expected to have a major impact on market share and logistics within hospitals [10] - Management noted that geopolitical factors have not significantly impacted operations, as most manufacturing occurs in the U.S. [51] Other Important Information - The company has received orphan drug designation for its lead investigational therapy BA102, which is being developed for the treatment of Phelan McDermott syndrome [13] - The company completed a $2 million equity financing to accelerate the preclinical development of its small molecule drug for autism [15] Q&A Session Summary Question: Is the approval of LungFit 2.0 included in the fiscal year 2026 guidance? - Management confirmed that the fiscal year 2026 guidance does not include the second-generation system [28] Question: What are the dynamics of international contracts and usage compared to U.S. hospitals? - Management indicated that initial shipments are for demonstration purposes, and the tender process outside the U.S. takes longer [30] Question: What is the expected timeline for FDA approval of LungFit PH2? - Management refrained from providing a specific timeline but noted that the FDA's average review time is around 180 days [78] Question: How does the company view the competitive landscape following a peer's new offering? - Management stated that they have not seen significant changes in contract negotiations due to the new offering from a competitor [84]