MY FIRST ATTEMPT AT DD, HERE GOES:
XAIR Beyond Air is a Nitric Oxide (NO) medical technology company with a few hardware products in the pipeline to treat severe lung infections (pending COVID-19 research, pulmonary hypertension of the newborn (PPHN), bronchiolitis and solid tumors.
They are on the verge of filing an application with the FDA for approval in its first indication of pulmonary hypertension of the newborn (PPHN). The market is > $600m. Current therapy of nitric oxide is provided via generator that uses high-pressure nitric oxide via cylinders. XAIR has a big step forward in technological innovation with a portable NO generator that generates NO from ambient air and doesn’t use cylinders. This provides big cost savings and safety improvements, an allows for treatment at-home.
XAIR valuation has been held back by continued delays in the FDA application and financial weakness of XAIR’s PPHN partner, Circassia. On the first, the application is now close to completion and should be submitted soon after the new year (maybe February). On the second, Circassia looks like it is rapidly running out of cash and has covered its problems with accounting gimmicks. I expect they are will be unable to do this at sometime in 2020. In addition, Circassia would be liable for $20m in stock or cash after FDA approval. This would represent around 25% of Circassia and they would still need the funds to launch the XAIR generator. As such, at some point in 2020 (maybe 1H20) XAIR will be able to exit the partnership. This would be a huge positive as I think it is likely that XAIR already has a big, household name partner waiting in the wings, and a partnership or merger could result in $50m in milestones including $25m upfront. Market cap of XAIR is just $40m so this is extremely significant.
In March, XAIR announced that FDA gave approval for XAIR to begin a study of 20 patients with 80 PPM nitric oxide to treat COVID-19 patients with mild-to-moderate symptoms.. https://www.beyondair.net/investors/news-events/press-releases/detail/105/beyond-air-receives-approval-from-health-canada-to-study
I believe if the above two events occur, XAIR will soon reach above its high again at $12.50. XAIR has several catalysts in 2020 – approval of the pulmonary hypertension FDA application, data on the NTM at-home pilot study at year-end 2020, etc. NTM is a huge indication. Approval of PPHN could result in a $25 stock and positive NTM data could result in a $50 stock post-NTM data.
Think the FDA did this because 80 PPM is the highest concentration of NO that’s been approved by the FDA previously and the LungFit system has never ever been used on humans in clinical trials. Naturally, the FDA wants to ensure that the generator and filter system is safe before allowing 150 PPM. This is supported by the fact that they only required 20 patients to be dosed at 80 PPM virus 75 requested. I read this as show us on a few patients that your system won’t kill them, which it won’t, and then you can dose to 150 PPM, which is required for antiviral activity.
In addition to nice potential to treat COVID-19 patients, I think this safety data should lead to much smoother approval of BRO Phase 3 study and the approval of PPHN marketing application, the first indication that could be launched in 4Q20.
If data comes out not in support of its cause, you may see a flat-lining of the stock price. However, the risk-to-reward ratio is worth the value of its current price. Read TLDR
$7 stock has upside to $35 on Persistent Pulmonary Hypertension of the Newborn (PPHN) by late this year and $65 by year-end on NTM data. Current market cap is $119M. Upon positive news from research and pending FDA approvals, this will be a multi-billion company. I remain very positive on prospects for XAIR because of COVID-19 opportunity but also the non-COVID indications.
I am not a financial advisor. Please do your own homework and research