Beyond Air Inc. (XAIR) has a couple of clinical trial catalysts up its sleeve, making the stock worth watching in the coming months.
Beyond Air is a clinical-stage medical device and biopharmaceutical company developing inhaled Nitric Oxide (NO) for the treatment of patients with respiratory conditions including serious lung infections and pulmonary hypertension.
The lead investigational asset is LungFit PH, a next-generation phasic flow ventilator compatible nitric oxide delivery system. The cylinder free system is proposed for the treatment of pulmonary hypertension for certain ventilated patients in the hospital setting.
The Company is planning to seek FDA approval for LungFit PH next quarter (Q2, 2020). If all goes well as planned, the device may be launched in the fourth quarter of this year. The market potential of LungFit PH in the U.S. is estimated to be over $300 million.
A $32.5 million commercial licensing agreement with Circassia Pharmaceuticals for LungFit PH in the United States and China was signed by Beyond Air last January.
However, Beyond Air terminated this agreement in December 2019 for material breach and is evaluating options for the commercialization of LungFit PH.
Next up in the pipeline is LungFit BRO for bronchiolitis, an infection of the small airways and a leading cause of global child mortality.
LungFit BRO for bronchiolitis has been successfully studied in Israel in two pilot studies. A third pilot study is underway, with results expected next quarter.
The Company expects to initiate a pivotal study of LungFit BRO in the U.S. in the fourth quarter of calendar 2020, with anticipated completion in the second quarter of 2021. The market opportunity for LungFit BRO in the U.S. is estimated to be over $500 million.
The other indications being evaluated by Beyond Air’s Nitric Oxide generator and delivery system LungFit are severe lung infections like Mycobacterium abscessus complex (MABSC) and Mycobacterium avium complex.
A multi-center, 12-week, self-administered, at-home pilot study of LungFit NTM in both Mycobacterium abscessus complex (MABSC) and Mycobacterium avium complex (MAC) patients, are expected to be initiated in mid-2020, with data anticipated in the first half of next year. The market potential of LungFit NTM in the U.S. is estimated to be more than $1 billion.
Recent Quarterly Scorecard:
For the fiscal third quarter ended December 31, 2019, the Company’s net loss widened to $4.9 million or $0.43 per share from $2.4 million or $0.28 per share in the year-ago quarter. Revenue for the three months ended December 31, 2019, was $300,000, all of which was licensing revenue. No revenue was generated in the fiscal third quarter of 2018.
As of December 31, 2019, the Company had cash and cash equivalents, restricted cash and marketable securities of $15.5 million.
XAIR has traded in a range of $3.45 to $7.29 in the last 1 year.
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