The design, timeline and takeaways of Beyond Air's study are presented in a ROTH Capital Partners report.
In a June 16 research note, ROTH Capital Partners analyst Scott Henry reported that Beyond Air Inc. (XAIR:NASDAQ) enrolled the first patient in its U.S. clinical trial that will test nitric oxide as a COVID-19 treatment. Data are expected in August.
"Nitric oxide has shown potential against viruses through blocking both RNA synthesis and viral replication. Data include in vitro analysis of SARS coronavirus and four patients with coronavirus," Henry indicated.
The analyst described the New York-based company's open-label study that is to be conducted at two sites. It will involve 20 patients who are hospitalized with COVID-19. To be randomized on a 1:1 basis, patients will receive standard supportive therapy alone or standard supportive therapy plus intermittent treatments of 80 parts per million (80 ppm) of nitric oxide over 40 minutes four times per day. Patients will be treated and evaluated for about seven days and then followed up at 30 days.
The trial's primary endpoint is time to clinical deterioration as determined by the need for noninvasive ventilation or oxygen via high flow nasal cannula or intubation. Other study endpoints will include viral load, need for additional oxygen, length of hospital stay, mortality and safety.
Henry highlighted that safety is the main focus of the U.S. study, as the maximum nitric oxide dose to be used in it is 80 ppm, which is "underdosed as antiviral therapy." The Canadian trial to follow, however, will concentrate on efficacy as it will test nitric oxide doses up to 150 ppm. Data from the Canadian trial are expected sometime in Q4/20.
ROTH has a Buy rating and an $11 per share target price on Beyond Air, the current share price of which is about $6.98. "We believe that the nitric oxide platform for Beyond Air is undervalued," commented Henry.
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Disclosures from ROTH Capital Partners,Beyond Air, Flash Note, June 16, 2020
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
Within the last twelve months, ROTH has received compensation for investment banking services from Beyond Air.
ROTH and/or its employees, officers, directors and owners own options, rights or warrants to purchase shares of Beyond Air stock.
Within the last twelve months, ROTH has managed or co-managed a public offering for Beyond Air.
ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.