On August 10, 2021 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, reported financial results for its first fiscal quarter ended June 30, 2021 (Press release, Beyond Air, AUG 10, 2021, View Source [SID1234586344]).
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"Our commercial team is ready to introduce the LungFit PH system to hospitals across the United States, with FDA approval anticipated to be received at the end of next month. I am confident in our ability to successfully bring to market what will be the first-ever FDA approved generator and delivery system that produces NO from ambient air. LungFit PH is designed to offer a simple, safe, cost effective and convenient alternative to the NO delivery systems that are currently available to treat PPHN," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. "We are making progress in our other programs and anticipate reporting interim data from our at-home NTM pilot study using LungFit GO in the fall. Our LungFit PRO acute viral pneumonia study in adults, which includes COVID-19 patients, remains open and we expect to discuss our progress with FDA this fall in order to plan next steps. We also expect to receive regulatory clearance to start human studies in our solid tumor program using ultra-high concentration gNO around the end of calendar year 2021 and begin enrolling patients in early 2022."
Duncan Fatkin, Chief Commercial Officer of Beyond Air, stated, "Our initial commercial launch team is in place with experienced leaders to head our sales and marketing efforts in the US, and our partnership efforts internationally. We established our supply chain well in advance and are now in the process of finalizing our marketing plan. As we get closer to the anticipated approval date, we are increasingly excited to fulfill Beyond Air’s vision of harnessing the power of nitric oxide to transform the lives of patients."
Recent Highlights and Upcoming Milestones
• LungFit PH
FDA review of the PMA to treat PPHN is ongoing
Commercial launch in the United States planned for the fourth quarter of calendar year 2021
Expect to secure CE Mark in the European Union around the end of calendar year 2021; followed by ex-U.S. commercial partnership in 2022
• LungFit PRO
Acute Viral Pneumonia Data
Initiated a pilot study for acute viral pneumonia in adults, including COVID-19 patients, in Israel using LungFit PRO at 150 ppm NO; patient enrollment began in November 2020 and is ongoing
Upcoming Study (pending discussions with FDA in Fall 2021)
Plan on initiating a pivotal trial for patients hospitalized with viral lung infections, either for acute viral pneumonia or bronchiolitis, in the fourth quarter of calendar year 2022
• LungFit GO
Initiated an at-home pilot study in Australia using LungFit GO for self-administration of up to 250 ppm NO for the treatment of refractory NTM lung disease in adult patients
Expect to report interim data for the at-home NTM lung infection pilot study at a medical or scientific conference in Fall 2021 with the trial completing in the first half of calendar year 2022
• Solid Tumor Program
Anticipate receiving regulatory clearance to initiate human studies around the end of calendar year 2021
Anticipate beginning the enrollment of patients in the first quarter of calendar year 2022
Financial results for the fiscal quarter ended June 30, 2021
Revenue for the fiscal quarter ended June 30, 2021 was $0 as compared to $229,000 for the fiscal quarter ended June 30, 2020, all of which was licensing revenue.
Research and development expenses for the fiscal quarter ended June 30, 2021 were $2.7 million, compared to $4.3 million for the fiscal quarter ended June 30, 2020.
General and administrative expenses for the fiscal quarter ended June 30, 2021 were $3.9 million, compared to $2.5 million for the fiscal quarter ended June 30, 2020.
For the fiscal quarter ended June 30, 2021, the Company had a net loss of $6.7 million, or ($0.31) per share, compared to a net loss of $6.7 million, or ($0.41) per share for the fiscal quarter ended June 30, 2020.
As of June 30, 2021, the Company had cash, cash equivalents and restricted cash of $39.6 million.