A：The operational highlights include a 128% year-over-year revenue increase to $1.8 million from $0.8 million in the same period last year, due to the adoption acceleration of their technology by hospitals using LungFit Ph. Financial results indicate the success of their technology in delivering clinical value and operational efficiency.

A：Despite the strong year-over-year growth, sequential growth was essentially flat compared to the prior quarter, reflecting the timing of hospital purchasing cycles and the variability in international shipments. To address these challenges and the inherent complexity of hospital sales cycles, Beyond Air has raised $12 million in debt and plans to file for an additional $20 million through an equity line of credit. They also believe the new sales model, which allows hospitals to purchase LungFit Ph systems outright, will help accelerate adoption.

A：Following the last update, Beyond Air has placed their technology in the first hospital outside the United States for commercial use and named board member Bob Goodman as interim chief commercial officer. The company has also introduced a capital purchase sales model in the United States, collected data from their Phase 1 trial, and updated their fiscal year 26 guidance to $8 to $10 million. They have received awards for therapeutic gases with Premier and Vizient, giving access to nearly 3000 hospitals. The company is preparing for the launch of their second-generation system, expected in late calendar year 2026 pending FDA approval. Additionally, they have extended existing customer contracts with multi-year agreements and increased anticipated volumes.

A：The strategic plans for the second generation of LungFit Ph include a focus on expanding into larger hospitals and health systems, anticipating a commercial launch in the U.S. market in late calendar year 2026 pending FDA approval. The second-generation system will be smaller, lighter, and designed for air and ground transportation while maintaining all the revolutionary features of the first generation. The company is also preparing for a highly anticipated launch of the second-generation system.

A：The new sales model has been well received, with initial system sales occurring after the quarter-end and receiving extremely positive feedback. This dual model approach allows hospitals to purchase LungFit Ph systems outright while continuing to generate recurring revenue for Beyond Air through disposables and service agreements. The flexibility of this new sales model is seen as an opportunity to accelerate the adoption of LungFit Ph.

A：The patent for the second generation Lung fit Ph has been allowed through 2040.

A：The Phase 1 A study found that patients with metastatic disease and heavily pretreated conditions had a mean of 10.3 prior surgeries, radiation, and medications, and all had a life expectancy less than 12 months. Treatment with Lung fit Ph showed a very clean safety profile, with only one patient experiencing a possibly attributable adverse event of grade 3 vasovagal response. Overall survival median and mean were 22 months and 21.2 months, respectively.

A：The next step for the program is to assess the best path forward, with a continued dedication to pursuing the Phase IB combination study with NPD lysr Py.

A：The US FDA has granted orphan drug designation to the investigational therapy BA 101 for the treatment of glioblastoma, and the Neurons team is working closely with regulators, investigators, patient groups, and foundations to accelerate its development.

A：Revenue increased 128% to $1.8 million, gross loss improved to $0.3 million from a loss of $1.1 million, and total operating expenses were reduced to just above $7.4 million from $11.7 million. Research and development expenses decreased to $2.5 million from $4.6 million, and selling, general, and administrative expenses decreased to $4.9 million from $7.2 million. The net loss was $7.9 million or a loss of $1.25 per share basic and diluted.

A：The company issued a $12 million promissory note to Streeterville Capital LLD with a 15% annual interest rate that matures in 24 months. No payments are due for the first 12 months. Additionally, an equity line of credit up to $150 million was entered into, dependent on the filing of an S-1 resale registration.

A：The expected growth drivers prior to the potential approval of the second-generation lung fit ph include expanding internationally, where the company has now entered 35 countries with partners and has placed systems in its first commercial hospital outside the United States. Additionally, the introduction of a capital purchase model for the current system, which is highly reliable, has generated interest, especially in the U.S. where hospitals can purchase the system along with ongoing purchases of filters and accessories.

A：The projected timeline for commercializing the second-generation lung fit ph around the end of calendar 2026 is not being constrained by FDA approval as the main limiting factor, but rather by challenges in the supply chain and the environment. These challenges include difficulties in obtaining necessary parts, global trade disagreements, and government shutdowns. The company is working towards readiness for contract manufacturing inspections and anticipates that commercialization will occur once these issues are resolved.

A：The key differences between the second-generation machine and the original model include its significantly reduced size, about 60% the size of the original, and the addition of FDA approval for ground and air transportation. An upgraded user interface based on feedback from current and future customers enhances the device's functionality and ease of use. Another notable improvement is an extended maintenance interval, reducing disruptions for high-volume users.

A：The new business model of purchasing the overall machine offers hospitals the ability to buy the system instead of leasing it, which aligns with preferences from hospitals that have expressed interest in purchasing. This model provides hospitals with the opportunity to buy disposables at a much lower rate than under the leasing model. The company is adopting this approach to cater to hospitals' needs for ownership while still offering various types of leases for the system. The introduction of the capital purchase model is in response to hospital requests and is expected to be utilized by hospitals that prefer to own their equipment.

A：The company's strategy for modeling international distributor revenue involves selling machines to distributors who then use various models, such as leasing or capital equipment purchases, in their markets. Additionally, distributors purchase machines as capital equipment and buy disposables, including filters, from the company. The filter renewal is a significant part of the model as it is the most important disposable for the company.

A：The revenue model is expected to become more repetitive and generate more revenue in fiscal 27 than in fiscal 26 due to the recent placement of systems in hospitals, which will lead to repeat business. The revenue growth is anticipated to pick up speed in fiscal 28 as the company is still waiting for regulatory approvals in many countries and the process of getting into hospitals is time-consuming.

A：The new guidance of 8 to 10 million reflects the expected sales for the back half of the year, taking into account the transition in the chief commercial officer position. The company does not expect immediate sales increases due to this transition and anticipates a period of disruption, hence the new guidance range.

A：The renewal process is going well, with many customers renewing for longer periods, such as transitioning from one-year contracts to three-year ones. The company is also seeing benefits from being on Premier, with hospitals that were not previously on the network solidifying their contracts. There is not much evidence of customers exiting the company's contracts, and the business is considered sticky due to the performance of the machines, the leasing model, and the support from the clinical team.