Beyond Air, Inc.

Good afternoon and welcome to the Beyond Air Financial Results Call for the second quarter of 2022, ended September 30th, 2021. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. And now, I would like to turn the call over to Maria Jankowski, Head of Investor Relations at Beyond Air. Please go ahead.

Thank you, Operator. Good afternoon, everyone, and thank you for joining us. Today, after market close, we issued a press release announcing the second fiscal quarter 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 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 statements. Additionally, this conference call is being recorded and will be available for audio rebroadcast on our website, www.beyondair.net. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, November 11, 2021. Beyond Air 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 new chief financial officer. With that, I will turn the call over to Steve Lisi, our CEO. Steve?

Thank you, Maria, and thanks, everyone, for joining us on the call this afternoon. This quarter has been a busy one, and I am excited to share our recent highlights with you as well as provide some insight on how we think about our active portfolio management strategy. Most significantly, we recently announced the separation of our oncology business into a new independently managed private entity called Beyond Cancer. This decision was made after careful consideration of what would be the best path forward for all stakeholders. I will talk about the future plans for our affiliate in greater detail in a minute. First, I want to give a quick update on our pending PMA application for the LungFit PH system to treat persistent pulmonary hypertension of the newborn, or PPHN. We are very pleased with our ongoing communication and progress with FDA. We will continue to provide FDA with any and all information and support they need to grant approval for our LungFit pH. Our commercial team is prepared to launch in December 2021, consistent with our guidance provided in September. This quarter, we also successfully completed the stage one assessment audit of our quality system for CE-MARC in Europe. We anticipate receiving CE-MARC in the first half of calendar 2022. I would defer to our Chief Commercial Officer, Duncan Fackin, to elaborate on our U.S. launch preparation shortly. Turning now to recent R&D highlights, in mid-October, we released interim data from our ongoing non-tuberculose mycobacteria, or NTM, pilot study using the LungFit Go device. As you may recall, we began screening patients for this trial in December 2020 in Australia. Despite some setbacks due to the difficult COVID-19 lockdown environment in Australia, The Beyond AIR team and our Australian colleagues have been doing an outstanding job navigating these challenges. At the time of data cutoff on September 6th, we had a total of eight refractory NTM patients enrolled, all of whom have been titrated up to the maximum dose of 250 parts per million nitric oxide with no dose reductions, no study discontinuations, and no treatment-related serious adverse events reported. To our knowledge, 250 parts per million is the highest concentration of inhaled nitric oxide that has ever been tested in a clinical trial with patients self-administering treatment in a home setting. These data provide a high level of comfort with respect to the safety of 250 parts per million NO because all subjects remained within the acceptable safety ranges from the hemoglobin levels and NO2 concentrations, below 10% in five parts per million, respectively. We attribute this success to the intermittent dosing regimen which allows for high-concentration NO to be administered without negative effects. Enrollment continues, and we anticipate reporting full safety and efficacy results in 2022. The success of this trial would be a game-changer for the home setting, but we could potentially target other chronic, severe lung infections with various underlying conditions, such as chronic obstructive pulmonary disease, or COPD, with our LungFitGo system. Moving on to our viral lung infection program, which uses the LungFit Pro system at 150 parts per million NO to treat acute viral pneumonia in adults and bronchiolitis in children under two years of age. Our pilot study in adult viral pneumonia, including COVID-19, remains active with trial sites open for enrollment. Our plan is to submit the entirety of the data at 150 to 160 parts per million NO in both hospitalized adult and infant viral pneumonia patient populations as one comprehensive data package to the FDA. We would like to move to a pivotal all-comer trial for LungFit Pro in patients hospitalized with viral pneumonia and anticipate pending agreement with FDA starting this study in the fourth quarter of calendar year 2022, the timing of which is due to the seasonality of most respiratory viruses. As a reminder, we've completed three randomized double-blind controlled studies in infants under the age of 12 months hospitalized with bronchiolitis, and there were consistent positive signals for both safety and efficacy in those trials. A total of 198 infants were enrolled in the three trials, and our third study provided statistical significance when 150 parts per million NO dose four times per day for up to five days was compared to standard of care for 85 parts per million NO for both the primary endpoint of fit to discharge from a hospital and the key secondary endpoint of hospital length of stay. In the adult viral pneumonia trial, to date we have presented data on 19 COVID-19 patients at the 2021 American Thoracic Society meeting in May 2021, and we showed data consistent with what was seen in the bronchiolitis studies. Finally, I will discuss our oncology business and the decision to spin it out into beyond cancer. The oncology program has always existed outside of the LungFit platform through the ultra-high concentrations of nitric oxide that are required to achieve anti-cancer properties. We have developed a proprietary device that, in a single treatment, can deliver up to 200,000 parts per million NO directly to a solid tumor site. We call this UNO therapy for ultra-high concentration nitric oxide. Based on our current preclinical findings, UNO therapy may not only partially ablate or shrink tumors locally, but also can arm the immune system to recognize and attack the same tumor type wherever it may reside in the body. Our preclinical data show that treating a tumor with immunotherapy will cause local cell death, exposing the immune system to tumor antigens, thereby creating a memory immune response. On a patient level, this could mean providing cancer patients and their families with the confidence that their disease will not recur or metastasize. Currently, the standard of care for solid tumors is surgery, cytotoxic chemotherapy, radiotherapy, or a combination of all three. While in recent years immunomodulating therapies have shown promise in improving outcomes for hematological cancers, a significant unmet need remains in the treatment of solid tumors. Solid tumors represent approximately 90% of adult human cancers, and metastatic disease is responsible for 90% of death from solid tumors. This is a huge market with a significant unmet medical need. Checkpoint inhibitors alone accounted for over 25 billion in sales in 2020. We believe that immunotherapy has the potential to improve the condition of patients with certain solid tumors as a monotherapy, but also believe that the effects of chemotherapy, radiation therapy, checkpoint inhibitors, as well as other treatments may be enhanced with NO combination therapy. The ONDAIR board and management team have been highly encouraged by the early results from the solid tumor program. Given this early promise, we recognized that our capital allocation strategy moving forward would change given the resources that would be required to accelerate the oncology program. Our focus is on the transformational LungFit platform technology and bringing it to the clinic as quickly and efficiently as possible. Thus far, resources that we have been investing in our oncology business were not impacting our LungFit programs. However, when evaluating our existing portfolio management strategy, it became clear that this separation of business was imminent and necessary. This will enable BeyondAire to solely focus on existing LungFit programs, as well as allow for investment into other respiratory diseases where we can have a greater impact on our patients. It was time to bring on a management team dedicated to oncology, and I am extremely pleased with the talent that will take on the mission of creating the next generation of immuno-oncology treatments. Beyond Cancer will be led by Chief Executive Officer Selina Chasson, a Stanford-trained physician who brings with her over 25 years of investment management experience from the financial sector, including the last 16 years as Director of Healthcare Investments at Baylor, where a substantial portion of her portfolio was oncology companies. Dr. Hilal Confino, the cancer immunologist who led the efforts at BeyondAire to bring this program to where it is today, has joined Beyond Cancer as Chief Scientific Officer to continue the journey with Dr. Chasson. It will be a pleasure to watch these two change the way we approach the treatment of solid tumors. Additionally, Beyond Cancer has received commitments from people for a few more key positions, including chief medical officer. Announcements for these hires will be made over the coming months. The Beyond Cancer board of directors will consist of six members, three of whom will be from Beyond Air. I will serve as chairman of the board. Our co-founder, president and chief operating officer, Amir Abniel, will serve as executive director. And Bob Carey, a current Beyond Air board member, will be a director. Lena Chasson will also be a director and will recruit two more members. Announcements on new board members as well as scientific advisory board members will begin shortly. None of this would be possible without a dedicated investor base. Recently, $23.9 million was raised in a private round to fund Beyond Cancer, which is subject to change with the final close occurring in a few weeks, but will not exceed $30 million. If $30 million is achieved, Beyond Air will own 80% of Beyond Cancer. Beyond Air will also benefit from a single-digit royalty payment on all future revenues. In exchange, Beyond Cancer will benefit from Beyond Air's nitric oxide expertise, intellectual property portfolio, preclinical oncology team, regulatory progress, and continued support across many areas, such as regulatory, legal, finance, and clinical, among others. The initial funding will be used to accelerate ongoing preclinical work, including the completion of IND-enabling studies and expansion of preclinical programs for combination studies. as well as completion of a phase one study, optimization of the NO delivery system, and building out the Beyond Cancer team. We truly believe that spinning off the oncology business will create long-term value for all shareholders, and we are excited to monitor the progress. I will now turn the call over to Duncan Fatkin, the Chief Commercial Officer of BeyondAire, to provide additional details on the U.S. commercial launch for LungFit PH.