Ladenburg: $XAIR: FY3Q21 Results; LungFit PH Approval Expected 2Q21; Reiterate Buy & $17 PT — which is +135% upside from $7.24 close yesterday.
$XAIR PMA approval for the PPHN—Approval/launch expected by 2Q21. We model sales starting in calendar 2H21. For the European market, CE mark is expected by EOY 2021 & potential launch in 2022 via a partnership. We expect an announcement of potential ex-US partnerships in 2021.
LungFit PRO study in Acute Viral Pneumonia, including COVID-19– $XAIR is running a multi-center, open-label, randomized clinical trial in Israel in ~90 adult patients We look forward to the interim readout for AVP w/ at 150 ppm & believe it could represent a significant catalyst.
As of January 31, 2021, $XAIR had proforma cash and restricted cash of $30.5 million. Me — Based on cash burn projections, I estimate cash sufficient for operations into mid-2022.
$XAIR NTM 12-week pilot study with self-administration (At-Home) of up to 250 ppm NO has been initiated & Initial data is expected by mid-2021, followed by full topline data about 6 months later. The first human study assessing gNO in tumor ablation could start by EOY 2021.
We reiterate our Buy rating and $17 price target. We remain confident that $XAIR has set itself up to execute its timeline for commercial launch and label expansion. We believe the upcoming milestones could serve as significant potential catalysts for the stock.