Beyond Air, Inc.

Greetings, and welcome to the Beyond Air third quarter 2022 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note, this conference is being recorded. I'll now turn the conference over to your host, Maria Yonkowski, head of investor relations. You may begin.

Thank you, Operator. Good afternoon, everyone, and thank you for joining us. Today, after market close, we issued a press release announcing the third fiscal quarter of 2022 operational highlights and financial results. A copy of this press release can be found on the Investor Relations page of our website. Before we begin, I would like to remind everyone that we will be making comments and various remarks about future expectations, plans, and prospects which constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Beyond Air cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated. We encourage everyone to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's Form 10-K, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statement. Additionally, this conference call is being recorded and will be available for audio rebroadcast on our website, www.beyonddare.net. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast. February 10th, 2022. Beyond DARE undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. Joining me on today's call are Steve Lisi, our chairman and chief executive officer, Duncan Fatkin, our chief commercial officer, and Douglas Larson, our chief financial officer. With that, I will turn the call over to Steve Lisi, our CEO. Steve?

Thanks, Maria. And good afternoon to everyone joining us on today's call. As always, I would like to start by thanking the Beyond Air team as they continue to embody the mission of our organization and move us forward towards regulatory approvals and R&D pipeline progression and expansion. We continue to believe in the potential of LungFit PH to revolutionize the treatment of persistent pulmonary hypertension of the newborn, or PPHN, in the United States and cardiac surgeries around the world. Today, our commercial team continues to prepare for a U.S. commercial launch of LungFit PH in anticipation of a regulatory decision in the first half of this calendar year. I will have our Chief Commercial Officer, Duncan Fatkin, discuss this preparation in much greater detail shortly. BeyondAir continues to work collaboratively with the FDA to bring our device to the market as quickly as possible. I won't be able to comment further on our ongoing interactions with the FDA, except to assure everyone that the dialogue is productive and we have provided the agency with all information and support we believe they need to grant approval for LungFit PH. Additionally, we remain on track to receive CE Mark in Europe in the first half of this calendar year. We expect to secure an international commercial partnership for LungFit PH for ex-U.S. markets following CE Mark and will provide more information on our global strategy at a later time. Turning now to recent operational highlights. In December of last year, we expanded our leadership team and welcomed Dr. Andrew Colon as our new Chief Medical Officer. Dr. Colon has been a valuable contributor to our Scientific Advisory Board since 2013, and his advice has been instrumental to the progress of our ongoing clinical programs to date. He has been tasked with leading our late-stage development efforts of both LungFit Pro and LungFit Go systems, given his medical background as a board-certified pediatric pulmonologist with more than four decades of clinical experience in respiratory physiology, cystic fibrosis, and lung infections. With regards to scientific updates and our presence at upcoming medical conferences, I am happy to report that we have been accepted to present new data from our pipeline programs at three leading scientific conferences all within the next four months. I will start off our pipeline commentary with our LungFitGo NTM lung infection pilot study. As you may recall, in December 2020, we began screening for refractory NTM patients for this pilot trial in Australia. In October, we released interim data where a total of eight refractory NTM patients had been titrated up to the maximum dose of 250 parts per million nitric oxide in the hospital over several days and then sent home to self-administer therapy. There were no dose reductions, no study discontinuations, and no treatment-related serious adverse events reported. Our team was very encouraged by this initial safety profile. We have now been accepted to present additional results from this pilot study at the American Thoracic Society International Conference being held from May 13th to May 18th in San Francisco. Beyond the safety profile, this study aims to evaluate efficacy parameters such as quality of life, physical function, and bacterial load, among other metrics. Remember, this is a pilot study designed as a single-arm, 12-week at-home trial aiming to enroll up to 20 cystic fibrosis or non-CF bronchiectasis patients with a refractory NTM lung infection, either mycobacterium avium complex or mycobacterium abscessus. It is important to note that NTM is a disease area of focus for FDA. In fact, 50% of patients will die in less than five years from from the initial diagnosis of mycobacterium abscessus lung infection. As such, the success of this trial could signal that LungFit Go has the potential to be a game changer for this patient population and start to open up the enormous potential of the home market for our system. We have always had an interest in investing in other indications with our LungFit Go system and have announced our intention of beginning a pilot study to treat severe COPD exacerbations due to lung infections over the next 12 to 24 months. Moving on to our viral lung infection program, which uses the LungFit Pro system at 150 parts per million nitric oxide to treat community-acquired viral pneumonia in adults and bronchiolitis in children under two years of age. As many of you may recall, we presented interim data from our adult cohort of hospitalized pneumonia patients last May at the American Thoracic Society International Conference. At the time of the cutoff period for these data, we analyzed a total of 19 patients on an intent-to-treat basis, 9 of the patients in the NO treatment arm and 10 in the control arm, all of which were COVID-19 patients. These data show that 150 parts from laying NO administered by a LungFit Pro was deemed to be safe and well-tolerated, with no treatment-related or possibly related adverse events or serious adverse events. Additionally, 22% of subjects in the NO treated group required oxygen support beyond their hospital stay, compared to 40% of control subjects. With respect to duration of oxygen support, NO treated patients averaged two days less than control. A 26-hour reduction in mean duration of hospital stay between the NO treatment group and control was observed when adjusting for extreme outliers. Since presenting these data, we have kept the study active with trial sites open for enrollment. I am happy to report that we have been accepted to present new data at the 32nd European Congress of Clinical Microbiology and Infectious Disease being held April 23rd through 26th in Lisbon. Our team is excited to have the opportunity to share these additional data with the scientific and medical communities. Finally, I would like to provide updates on our private affiliate, Beyond Cancer. Late last year, we successfully raised $30 million in a private placement of common shares to spin out our oncology program developing ultra-high concentration nitric oxide, or UNO therapy, for the treatment of solid tumors. We believe UNO therapy may not only partially ablate or shrink the primary tumor, but also can arm the immune system to recognize and attack same tumor cells if they metastasize to other regions in the body. Our preclinical data show that treating a tumor with UNO therapy will cause local cell death, exposing the immune system to tumor antigens, thereby creating a memory immune response. For patients, this could mean preventing recurrence or metastases. Under the leadership of CEO, Dr. Selina Chasson, Beyond Cancer has established its six-member board with the recruitments of Mr. David Dvorak, previously the CEO of Zimmer Biomed, and Dr. Gregory Burke, a clinically trained physician who is currently serving as a chief medical officer and interim CEO of GT Biopharma, a clinical stage immuno-oncology company. Additionally, Beyond Cancer will present two data sets at the American Association for Cancer Research annual meeting, which is being held from April 8th through 13th in New Orleans. Recall, we previously presented in vitro and in vivo preclinical data for ultra-high concentration gaseous nitric oxide at several conferences in 2020, which suggested that direct administration of UNO therapy to solid tumors triggers a systemic anti-tumor immune response, which could serve as the basis for an effective immunotherapy. These new preclinical data being presented in April will continue to build upon this growing body of evidence, and we are excited to support the progress as a partner of Beyond Cancer. I will now turn the call over to Duncan Fatkin, the Chief Commercial Officer of Beyond Air, to provide additional details on the U.S. commercial launch for LungFit PH.