Persistent Fetal Circulation Syndrome

U.S. commercial launch continues for LungFit® PH for the treatment of term and near-term neonates with hypoxic respiratory failure Presented positive in vivo combination data with anti-PD1 that support the potential of the Company’s novel gaseous ultra-high concentration nitric oxide (UNO) therapy to treat various types of solid tumors at the Society for Immunotherapy of Cancer (SITC) 2022 Annual Meeting Published pre-clinical data in the peer-reviewed journal Cancer Cell International (“CCI”) on the Company’s patented tumor ablation method utilizing UNO Conference call scheduled for 4:30 p.m. ET today, February 9th GARDEN CITY, N.Y., Feb. 09, 2023 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR) (“Beyond Air” or the “Company”) a commercial stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced financial results for its third fiscal quarter ended December 31, 2022. “We are successfully executing on our planned limited launch of LungFit PH in the United States. Demand among targeted hospitals for demonstrations and evaluations continues to grow, and we look forward to recording our first sales during the March quarter,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “Over the past few years, we have presented data which have demonstrated the safety of inhaled nitric oxide at high concentrations, administered intermittently, in more than 12 clinical settings with over 170 patients treated and more than 5,000 treatments administered with no serious adverse reactions related to nitric oxide. Strong efficacy signals were also demonstrated, especially in viral respiratory infections. We believe high concentration NO delivery with our LungFit PRO generator and delivery system can be a powerful tool against any type of pneumonia, regardless of the type of virus, including SARS-CoV2, and our company is dedicated to bringing this important therapy to market as soon as possible.” “Throughout the year, the team at Beyond Cancer has made incredible progress,” continued Mr. Lisi. “The pre-clinical results presented during the Society for Immunotherapy of Cancer (SITC) 2022 annual meeting in November offer an encouraging first look at the potential synergistic effect of UNO therapy when combined with anti-PD-1 therapy. We are pleased to have also published our early pre-clinical work in the peer-reviewed journal Cancer Cell International (“CCI”) in December. These impressive data support our understanding of UNO as an immunomodulating therapeutic option for the treatment of solid tumors and prevention of metastases and we look forward to further elucidating the powerful effects of UNO in human trials.” Recent Highlights and Upcoming Milestones LungFit® PH Ongoing progress with limited release phase of commercial launch, making it the first and only nitric oxide generator, delivery, and monitoring system available in the United States CE Mark anticipated to be received in the first half of fiscal year 2024, which is expected to be followed by an international commercial partnership Expect to submit a PMA supplement for a cardiac label expansion for LungFit® PH to the FDA in the first half of calendar year 2023 LungFit® PRO ID Week 2022 – the Company presented positive data showing a strong safety pro statistically significant results on key endpoints in patients hospitalized with viral respiratory infections, including SARS-CoV2 Plan to initiate a U.S. trial for patients hospitalized with viral community-acquired pneumonia (VCAP), including COVID-19, in the fourth quarter of calendar year 2023, pending discussion with the FDA LungFit® GO American College of Chest Physicians (CHEST) Annual Meeting 2022 – the Company presented positive safety, tolerability, and efficacy data from the LungFit GO pilot at-home study of patients with severe, treatment refractory, NTM lung disease Plan to initiate a U.S. trial for patients with NTM in the second half of fiscal year 2025, pending discussion with the FDA Plan to initiate a U.S. pilot trial in COPD patients who are hospitalized due to a exacerbation in the fourth quarter of calendar 2024, pending discussion with FDA Beyond Cancer’s Solid Tumor Program Society for Immunotherapy of Cancer (SITC) Annual Meeting 2022 - presented promising new data in mice for UNO therapy, which showed a doubling of survival when UNO was combined with anti-PD1 compared with anti-PD1 alone Published pre-clinical data in Cancer Cell International (CCI) on December 13, 2022, which demonstrated that the company’s tumor ablation method results in a potent systemic immune response to the specific tumor type treated. Treated mice were immune to a re-introduction or tumor challenge resulting in a significant improvement in survival for UNO treated mice compared to control mice Received a notice of allowance for its patent titled, “System and Method for Delivery or Gas to a Tissue”, which is the first patent covering Beyond Cancer’s UNO therapy Announced a sponsored research agreement with Stanford University, and the expansion of Beyond Cancer’s Scientific Advisory Board (SAB) Financial Results for the Fiscal Quarter Ended December 31, 2022 Research and development expenses for the fiscal quarter ended December 31, 2022 were $5.0 million, compared with $2.5 million for the fiscal quarter ended December 31, 2021. The increase was driven mainly by compensation costs from scaling up operations in Beyond Cancer as well as from increased investments in pre-clinical work being done across the Group in our targeted therapeutic areas. General and administrative expenses for the fiscal quarter ended December 31, 2022 increased to $8.9 million, compared with $4.9 million for the fiscal quarter ended December 31, 2021. The increase includes $3.0 million of planned structural investments in Beyond Cancer and $1.0 million attributable to continued investments in people and systems necessary to support the commercial launch of LungFit® PH in the U.S. Other income and expense was a $0.2 million gain for the fiscal quarter ended December 31, 2022, compared with a $0.5 million loss for the fiscal quarter ended December 31, 2021. The two main drivers in this year-over-year improvement were gains made from the Company’s investment in marketable securities as well as favorable foreign exchange movements. For the fiscal quarter ended December 31, 2022, the Company had a GAAP net loss of $13.8 million, of which $12.7 million, or ($0.43) per share, was attributable to the shareholders of Beyond Air, Inc., compared with a net loss of $7.7 million, or ($0.29) per share, for the fiscal quarter ended December 31, 2021. As of December 31, 2022, the Company reported cash and cash equivalents, marketable securities, and restricted cash of $63.2 million. Total cash burn in the quarter ended December 31, 2022, was $9.3 million, which is in line with the Company’s quarterly cash burn guidance of $8.0 – 10.0 million per quarter. Through the first nine months of the Company’s fiscal year 2023, total cash burn was $27.0 million which includes $2.5 million in non-recurring expense. Conference Call & Webcast Thursday, February 9th @ 4:30 PM ET Domestic: 1-844-825-9789 International: 1-412-317-5180 Passcode: 2849570 Webcast: or the Events page of the Company’s website (click here) About Beyond Air®, Inc. Beyond Air is a commercial stage medical device and biopharmaceutical company dedicated to harnessing the power of nitric oxide through its revolutionary NO Generator and Delivery System, LungFit, that uses NO generated from ambient air to deliver precise amounts of NO to the lungs for the potential treatment of a variety of pulmonary diseases. The LungFit can generate up to 400 ppm of NO, for delivery either continuously or for a fixed amount of time and has the ability to either titrate dose on demand or maintain a constant dose. The Company has received FDA approval for its first system, LungFit PH for persistent pulmonary hypertension of the newborn. Beyond Air is currently advancing its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19), nontuberculous mycobacteria (NTM) and severe lung infections in other settings. Additionally, Beyond Cancer, an affiliate of Beyond Air, is investigating ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit . About Nitric Oxide Nitric Oxide is a powerful molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens, including mycobacteria, viruses, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains. About the LungFit®* Beyond Air’s LungFit is a cylinder-free, phasic flow generator and delivery system and has been designated as a medical device by the U.S. Food and Drug Administration (FDA). The ventilator compatible version of the device can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 ppm to 80 ppm. The LungFit system could potentially replace large, high-pressure NO cylinders providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall safety with the elimination of NO2 purging steps, and other benefits. The LungFit can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting (e.g. COVID-19, bronchiolitis) and chronic, refractory lung infections in the home setting (e.g. NTM). With the elimination of cylinders, Beyond Air intends to offer NO treatment in the home setting. * Beyond Air’s LungFit PH is approved for commercial use only in the United States of America to treat term and near-term neonates with hypoxic respiratory failure. Beyond Air’s other LungFit systems are not approved for commercial use and are for investigational use only. Beyond Air is not suggesting NO use over 80 ppm or use at home. About PPHN Persistent pulmonary hypertension of the newborn (PPHN) is a lethal condition and secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1000 live births (0.4–6.8/1000 live births) with mortality rate ranging between 4–33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality. NO gas is a vasodilator, is approved in dozens of countries to improve oxygenation and reduces the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents. About Viral Community-Acquired Pneumonia (VCAP) In adults, viruses have been identified as the causative agents in approximately 100 million cases of community-acquired pneumonia per year. While viral pneumonia in adults is most commonly caused by rhinovirus, respiratory syncytial virus (RSV) and influenza virus, newly emerging viruses (including SARS-CoV-1, SARS-CoV-2, avian influenza A, and H1N1 viruses) have been identified as pathogens contributing to the overall burden of adult viral pneumonia. Patients aged 65 years or older are at particular risk for death from the disease, as are patients with other underlying health conditions or weakened immune systems. There is no consensus regarding the use of antiviral drugs to treat viral pneumonia, and specific preventative measures are currently limited to the influenza vaccine. Given that current treatment recommendations are largely limited to supportive care, there is an unmet medical need for effective treatment options. NO may prove to be a treatment as the impact on the lung should result in bronchodilation, reduction in inflammation and inhibition of the viral replication process. About NTM Nontuberculous mycobacteria (NTM) infection is a rare and serious bacterial infection in the lungs causing debilitating pulmonary disease associated with high morbidity and mortality. NTM infection is acquired by inhaling aerosolized bacteria from the environment, and can lead to NTM lung disease, a progressive and chronic condition. According to the Cystic Fibrosis Foundation, 13% of U.S. cystic fibrosis patients had a positive culture for a NTM species in 2017. NTM is considered an emerging public health concern worldwide because of its multi-drug antibiotic resistance. Current treatment guidelines suggest a combination of multiple antibiotics dosed chronically for as long as two years. These complex, expensive and invasive regimens have a poor record in the treatment of Mycobacterium abscessus complex (MABSC) and refractory Mycobacterium avium complex (MAC) and have the potential to cause severe adverse events. Beyond Air’s system is designed to deliver 150 – 400 ppm NO to the lungs, and early data, including from the pilot study of the LungFit GO, indicate that this range of NO concentrations could have a positive effect on patients infected with NTM. About Bronchiolitis The majority of hospital admissions of infants with bronchiolitis are caused by respiratory syncytial virus (RSV). RSV is a common and highly transmissible virus that infects the respiratory tract of most children before their second birthday. While most infants with RSV present with minor respiratory symptoms, a small percentage develop serious lower airway infections, termed bronchiolitis, which can become life-threatening. The absence of treatment options for bronchiolitis limits the care of these sick infants to largely supportive measures. Beyond Air’s system is designed to effectively deliver 150 – 400 ppm NO, for which preliminary studies indicate may eliminate bacteria, viruses, fungi, and other microbes from the lungs. About Beyond Cancer, Ltd. Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc., is a development-stage biopharmaceutical and medical device company utilizing ultra-high concentration nitric oxide (UNO) via a proprietary delivery platform to treat primary tumors and prevent metastatic disease. Nitric oxide at ultra-high concentrations has been reported to show anticancer properties and to potentially serve as a chemosensitizer and radiotherapy enhancer. A first-in-human study is underway in patients with solid tumors. The Company is conducting preclinical studies of UNO in multiple solid tumor models to inform additional treatment protocols. For more information, visit . About UNO Therapy for Solid Tumors Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately 90% of all cancer-related deaths. Current cancer treatment modalities generally include chemotherapy, immunotherapy, radiation, and/or surgery. Ultra-high concentration Nitric Oxide (UNO) therapy is a completely new approach to preventing relapse or metastatic disease. In vitro murine data show that local tumor ablation with UNO stimulates an anti-tumor immune response in solid tumor cancer models. The Company believes that UNO has the potential to prevent relapse or metastatic disease with as little as a single 5-minute treatment and with limited toxicity or off-target effects. Forward Looking Statements This press release contains “forward-looking statements” concerning the potential safety and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “expects,” “plans,” “anticipates,” “believes” “expects,” “intends,” “looks,” “projects,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect views as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: Beyond Cancer’s ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials concerning the ultra-high concentration nitric oxide product candidate; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for the ultra-high concentration nitric oxide product candidate; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; Beyond Cancer’s ability to fund and the results of further pre-clinical studies and clinical trials of the ultra-high concentration nitric oxide product candidate; obtaining, maintaining and protecting intellectual property utilized by products; obtaining regulatory approval for products; competition from others using similar technology and others developing products for similar uses; dependence on collaborators; and other risks, which may, in part, be identified and described in the “Risk Factors” section of Beyond Air’s most recent Annual Report on Form 10-K and other of its filings with the Securities and Exchange Commission, all of which are available on Beyond Air’s website. Beyond Cancer and Beyond Air undertake no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law. CONTACTS: Investor Relations contacts Edward Barger Head of Investor Relations ebarger@beyondair.net Corey Davis, Ph.D. LifeSci Advisors, LLC Cdavis@lifesciadvisors.com (212) 915-2577 Media contacts Kori-Ann Taylor Head of Marketing ktaylor@beyondair.net BEYOND AIR, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (amounts in thousands, except share and per share data) December 31, 2022 March 31, 2022 (Unaudited) ASSETS Current assets Cash and cash equivalents $ 25,478 $ 80,242 Marketable securities 27,641 - Restricted cash 10,085 9,988 Inventory, net 955 350 Grant receivable 355 322 Other current assets and prepaid expenses 1,500 2,044 Total current assets 66,015 92,945 Licensed right to use technology 1,683 1,837 Right-of-use lease assets 2,426 2,216 Property and equipment, net 3,624 1,995 Other assets 211 207 TOTAL ASSETS $ 73,959 $ 99,199 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $ 1,411 $ 1,129 Accrued expenses 9,777 8,374 Operating lease liability 349 281 Loan payable, current portion 60 927 Total current liabilities 11,597 10,712 Operating lease liability 2,282 2,079 Long-term debt, net 140 200 Other long-term liabilities 4,500 8,000 Total liabilities 18,519 20,990 Stockholders’ equity Preferred Stock, $0.0001 par value per share: 10,000,000 shares authorized, 0 shares issued and outstanding - - Common Stock, $0.0001 par value per share: 100,000,000 shares authorized, 30,013,907 and 29,886,173 shares issued and outstanding as of December 31, 2022 and March 31, 2022, respectively 3 3 Treasury stock (25 ) (25 ) Additional paid-in capital 210,097 196,269 Accumulated deficit (159,288 ) (123,639 ) Accumulated other comprehensive income 159 96 Total stockholders’ equity attributable to Beyond Air, Inc 50,946 72,704 Non-controlling interests 4,494 5,505 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 73,959 $ 99,199 BEYOND AIR, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (amounts in thousands, except share and per share data) (UNAUDITED) For the Three Months Ended For the Nine Months Ended December 31, December 31, 2022 2021 2022 2021 Revenue $ - $ - $ - $ - Cost of Revenue 68 - 247 - Gross Profit / (Loss) (68 ) - (247 ) - Operating expenses: Research and development 5,000 2,543 12,679 8,091 General and administrative 8,941 4,943 25,144 12,188 Operating expenses 13,941 7,486 37,823 20,279 Operating loss (14,010 ) (7,486 ) (38,070 ) (20,279 ) Other income (loss) Interest expense (46 ) (57 ) (142 ) (377 ) Foreign exchange gain / (loss) 286 (8 ) (108 ) 2 Estimated Liability for Contingent loss (248 ) - (248 ) (2,742 ) Other income / (expense) 219 (412 ) 317 - Total other expense 211 (476 ) (180 ) (3,118 ) Benefit from income taxes - - - - Net loss $ (13,798 ) $ (7,962 ) $ (38,250 ) $ (23,397 ) Less : net loss attributable to non-controlling interests (1,051 ) (223 ) (2,601 ) (223 ) Net loss attributable to Beyond Air, Inc. $ (12,747 ) $ (7,739 ) $ (35,649 ) $ (23,174 ) Foreign currency translation gain and loss (184 ) - 159 - Comprehensive loss attributable to Beyond Air, Inc. $ (12,931 ) $ (7,739 ) $ (35,490 ) $ (23,174 ) Net basic and diluted loss per share attributable to Beyond Air, Inc. $ (0.43 ) $ (0.29 ) $ (1.19 ) $ (0.95 ) Weighted average number of shares, outstanding, basic and diluted 29,921,254 26,822,302 29,902,694 24,319,771

LungFit PH is a prescription-only device indicated for the treatment of hypoxic respiratory failure, commonly called persistent pulmonary hypertension of the newborn (PPHN), in neonates The LungFit platform leverages patented Ionizer technology. (Credit: Beyond Air) Beyond Air has received the US Food and Drug Administration (FDA) approval for its LungFit PH device to treat a type of hypoxic respiratory failure in neonates. The prescription-only device is indicated for neonates with hypoxic respiratory failure, commonly called persistent pulmonary hypertension of the newborn (PPHN). PPHN is a severe condition characterised by elevated pulmonary vascular resistance (PVR) leading to labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. LungFit PH, part of the company’s LungFit therapeutic platform of nitric oxide (NO) generators, uses  Beyond Air’s patented Ionizer technology. It is the company’s first FDA-approved product that generates on-demand NO from ambient air for the treatment of term and near-term neonates with hypoxic respiratory failure. NO gas is a vasodilator approved in many countries worldwide to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in neonates. Beyond Air chairman and CEO Steve Lisi said: “The FDA approval of LungFit PH enables a new era of nitric oxide therapy and marks a pivotal event for Beyond Air as we officially enter the US market. “As the first and only approved nitric oxide generator and delivery system, LungFit PH empowers healthcare providers to maximise the efficiency of a hospital when treating PPHN by moving beyond their reliance on traditional, inefficient delivery systems and the associated burdensome logistics and safety requirements. “I am immensely proud of the Beyond Air team for navigating a multitude of obstacles over the past five years, especially the last 27 months during the global pandemic, to bring this revolutionary device to market.” LungFit PH leverages a compressor to drive the room air through a plasma chamber and generates pulses of electrical discharge between two electrodes. The system uses power equivalent to a 60W lightbulb to ionize the nitrogen and oxygen molecules, to generate NO with low levels of nitrogen dioxide (NO2) as a by-product. When the gas generated is passed through a Smart Filter, the toxic NO2 constituent is removed from the internal circuit. A Smart Filter lasts 12 hours despite ventilator demands. Beyond Air said that its LungFit PH system is designed to deliver NO to the lungs to treat PPHN, at a dosage strength consistent with the current standard of care. “The approval of LungFit PH validates our patented Ionizer technology and lays out a premarket approval model for our other LungFit platform devices, including LungFit PRO and LungFit GO. “We believe that LungFit PH is just the first in a series of our medical devices that, if approved, will become available for treating a wide variety of respiratory diseases as we remain dedicated to our mission of harnessing the power of nitric oxide for all who can benefit from this transformational therapy.”

LungFit® PH received FDA approval for the treatment of term and near-term neonates with hypoxic respiratory failure on June 28, 2022 and the first phase of U.S. commercial launch has begun Presented positive data for high-concentration nitric oxide (NO) with LungFit® PRO in hospitalized patients with community-acquired viral pneumonia, including COVID-19, at ECCMID 2022 Presented positive long-term safety data for high-concentration NO at PAS 2022 in infants hospitalized with bronchiolitis Presented positive updated interim data from the ongoing at-home LungFit® GO pilot study for nontuberculous mycobacterial lung disease at ATS 2022 Patient screening has begun for the Phase I trial of ultra-high concentration gaseous NO (UNO) being conducted by the Company’s oncology affiliate, Beyond Cancer™ Conference call scheduled for 4:30 p.m. ET today, June 28th GARDEN CITY, N.Y., June 28, 2022 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced financial results for its fiscal fourth quarter and year ended March 31, 2022. “Through hard work and dedication, we have achieved the goal of FDA approval for our first LungFit® system,” commented Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “We believe the introduction of this groundbreaking system, LungFit PH, will transform the way nitric oxide is used by hospital staff and provide numerous benefits related to safety and cost. In addition, we are on track to receive CE Mark for LungFit PH in Europe during the second half of calendar year 2022. Looking beyond LungFit PH, we believe receiving this initial regulatory approval in the U.S. validates our patented Ionizer™ technology and creates a path forward for the other devices in the LungFit platform, including LungFit PRO and LungFit GO, to address other respiratory indications with even larger patient populations with unmet medical needs.” Mr. Lisi added, “Over the past few months we have taken significant strides in our other clinical programs, presenting new data at four medical conferences. This includes positive safety and efficacy data for high-concentration NO with LungFit PRO in patients hospitalized with community-acquired viral pneumonia at ECCMID 2022 and positive long-term safety data in infants hospitalized with bronchiolitis at PAS 2022, strengthening our previously reported strong data. Additionally, at the ATS 2022 conference we presented positive interim data from our NTM pilot study using the LungFit GO to deliver up to 250 ppm NO in the home setting. “Lastly, at AACR 2022 our oncology affiliate, Beyond Cancer, presented positive new preclinical data for its ultra-high concentration gaseous NO (UNO) therapy for solid tumors. Beyond Cancer’s Phase I first-in-human study for UNO therapy in solid tumors is open for enrollment. We continue to be excited by the progress this talented team is making as they advance the development of UNO therapy to treat solid tumors,” concluded Mr. Lisi. Recent Highlights and Upcoming Milestones • LungFit® PH •Received U.S. FDA approval on June 28, 2022 for PPHN •Initial limited release phase for commercial launch underway, making it the first and only nitric oxide generator and delivery system available in the U.S. •CE Mark approval anticipated to be received in the second half of calendar year 2022, which is expected to be followed by international commercial partnership • LungFit® PRO Community-Acquired Viral Pneumonia (CAVP) Data (including COVID-19) •Presented data from a pilot study in patients hospitalized with CAVP, including COVID-19 patients, at the 32nd European Congress of Clinical Microbiology and Infectious Disease in April 2022; data showed 150 ppm NO, administered with LungFit PRO continued to be well-tolerated with no treatment-related adverse events and showed encouraging efficacy signals for shortening hospital length of stay and duration of oxygen supplementation Bronchiolitis •Presented positive long-term safety data for high-concentration inhaled NO at the Pediatric Academic Societies Meeting (PAS) in April 2022; results from 101 infants dosed with either standard supportive treatment (SST) or 85, 150 or 160 ppm NO showed that re-hospitalization due to bronchiolitis related reasons trended favorably for the inhaled NO group and the long-term subject re-hospitalization rate for any reason was similar between inhaled NO and control Upcoming Study •Plan on initiating a U.S. trial for patients hospitalized with CAVP in the fourth quarter of calendar 2023, pending discussion with FDA • LungFit® GO •Presented data from an updated interim analysis from the ongoing pilot study for 250 PPM NO self-administered by refractory NTM lung infection patients in the home-setting at the American Thoracic Society (ATS) 2022 International Conference in May 2022; these data showed that 250 ppm inhaled NO was well tolerated following a total of 2,323 inhalations self-administered in the home setting with no treatment related discontinuations reported and overall high treatment compliance among the 15 subjects enrolled per the data cut-off date •A pilot study in COPD patients who are hospitalized due to an exacerbation is expected to begin in the second half of calendar 2023 with treatment both in-hospital and at-home • Beyond Cancer’s Solid Tumor Program •Presented positive in vivo and in vitro data at the American Association for Cancer Research (AACR) Annual Meeting in April 2022; these data suggested that ultra-high concentration gaseous NO (UNO) induced both innate and adaptive immune cell populations, and a decline in immune suppressor cells, which are indicative of an anti-tumor immune response •Patient screening in the Phase 1 human study has begun • Corporate Highlights •Amir Avniel, co-founder, president and chief operating officer will now serve as president and chief business officer of Beyond Air •Mike Gaul, SVP operations, will now serve as chief operating officer of Beyond Air •Jedidiah Monson appointed as chief medical officer at Beyond Cancer •Susan Jones appointed as chief financial officer at Beyond Cancer Financial results for the fiscal year ended March 31, 2022 Revenue for the fiscal year ended March 31, 2022 was $0 as compared to $0.9 million for the fiscal year ended March 31, 2021, all of which was licensing revenue. Research and development expenses for the fiscal year ended March 31, 2022 were $11.8 million, compared to $12.6 million for the fiscal year ended March 31, 2021. General and administrative expenses for the fiscal year ended March 31, 2022 increased to $18.4 million, from $10.5 million for the fiscal year ended March 31, 2021, mainly due to the structural investments required to prepare the Company for commercial launch in the U.S. Other operating expenses for the fiscal year ended March 31, 2022 were $10.5 million, entirely related to the contingent liability in the settlement agreement with Circassia which was recognized in the fourth quarter of fiscal 2022 in accordance with GAAP. $2.5 million of this liability is due within the next 12 months. Other income and expense for the fiscal year ended March 31, 2022 was a loss of $3.4 million compared to $0.7 million for the fiscal year ended March 31, 2021. In the fiscal year ended March 31, 2022, the Company recorded an estimated liability for contingent loss related to a lawsuit for $2.4 million. For the fiscal year ended March 31, 2022, the Company had a net loss of $44.1 million of which $43.2m or ($1.68) per share was attributable to the shareholders of Beyond Air, compared to a net loss of $22.9 million, or ($1.27) per share for the fiscal year ended March 31, 2021. As of March 31, 2022, the Company had cash and cash equivalents of $80.2 million. Conference Call & WebcastThursday, June 28th @ 4:30 PM ETDomestic: 877-407-0784International: 201-689-8560Passcode: 13729815Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1547908&tp_key=64be312891 or the Events page of the Company’s website (click here) About Beyond Air, Inc.Beyond Air, Inc. is a clinical-stage medical device and biopharmaceutical company developing a revolutionary NO Generator and Delivery System, LungFit®, that uses NO generated from ambient air to deliver precise amounts of NO to the lungs for the potential treatment of a variety of pulmonary diseases. The LungFit® can generate up to 400 ppm of NO, for delivery either continuously or for a fixed amount of time and has the ability to either titrate dose on demand or maintain a constant dose. The Company is currently applying its therapeutic expertise to develop treatments for pulmonary hypertension in various settings, in addition to treatments for respiratory tract infections that are not effectively addressed with current standards of care. Beyond Air is currently advancing its revolutionary LungFit® for clinical trials for the treatment of severe lung infections such as acute viral pneumonia (including COVID-19) and nontuberculous mycobacteria (NTM). Additionally, Beyond Air is using ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit www.beyondair.net. About Nitric Oxide (NO)Nitric Oxide (NO) is a powerful molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries, and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens, including mycobacteria, viruses, fungi, yeast, and parasites, and has the potential to eliminate multi-drug resistant strains. About the LungFit®*Beyond Air’s LungFit® is a cylinder-free, phasic flow nitric oxide generator and delivery system and has been designated as a medical device by the U.S. Food and Drug Administration (FDA). The ventilator compatible version of the device can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 part per million (ppm) to 80 ppm. The LungFit® system could potentially replace large, high-pressure NO cylinders providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall safety with the elimination of NO2 purging steps, and other benefits. The LungFit® can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting (e.g. COVID-19, bronchiolitis) and chronic, refractory lung infections in the home setting (e.g. NTM). With the elimination of cylinders, Beyond Air intends to offer NO treatment in the home setting. * Beyond Air’s LungFit® is not approved for commercial use. Beyond Air’s LungFit® is for investigational use only. Beyond Air is not suggesting NO use over 80 ppm or use at home. About PPHNPersistent pulmonary hypertension of the newborn (PPHN) is a lethal condition and secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1000 live births (0.4–6.8/1000 live births) with mortality rate ranging between 4–33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality. NO gas is a vasodilator, is approved in dozens of countries to improve oxygenation and reduces the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents. About Community Acquired Viral PneumoniaIn adults, viruses have been identified as the causative agents in approximately 100 million cases of community-acquired pneumonia per year. While viral pneumonia in adults is most commonly caused by rhinovirus, respiratory syncytial virus (RSV) and influenza virus, newly emerging viruses (including SARS-CoV-1, SARS-CoV-2, avian influenza A, and H1N1 viruses) have been identified as pathogens contributing to the overall burden of adult viral pneumonia. Patients aged 65 years or older are at particular risk for death from the disease, as are patients with other underlying health conditions or weakened immune systems. There is no consensus regarding the use of antiviral drugs to treat viral pneumonia, and specific preventative measures are currently limited to the influenza vaccine. Given that current treatment recommendations are largely limited to supportive care, there is an unmet medical need for effective treatment options. About NTMNontuberculous mycobacteria (NTM) infection is a rare and serious bacterial infection in the lungs causing debilitating pulmonary disease associated with high morbidity and mortality. NTM infection is acquired by inhaling aerosolized bacteria from the environment, and can lead to NTM lung disease, a progressive and chronic condition. According to the Cystic Fibrosis Foundation, 13% of U.S. cystic fibrosis patients had a positive culture for a NTM species in 2017. NTM is an emerging public health concern worldwide because of its multi-drug antibiotic resistance. Current treatment guidelines suggest a combination of multiple antibiotics dosed chronically for as long as two years. These complex, expensive and invasive regimens have a poor record in the treatment of Mycobacterium abscessus complex (MABSC) and refractory Mycobacterium avium complex (MAC) and have the potential to cause severe adverse events. Beyond Air’s system is designed to deliver 150 - 400 ppm NO to the lung, and early data indicate that this range of NO concentrations could have a positive effect on patients infected with NTM. About BronchiolitisThe majority of hospital admissions of infants with bronchiolitis are caused by respiratory syncytial virus (RSV). RSV is a common and highly transmissible virus that infects the respiratory tract of most children before their second birthday. While most infants with RSV present with minor respiratory symptoms, a small percentage develop serious lower airway infections, termed bronchiolitis, which can become life-threatening. The absence of treatment options for bronchiolitis limits the care of these sick infants to largely supportive measures. Beyond Air’s system is designed to effectively deliver 150 - 400 ppm NO, for which preliminary studies indicate may eliminate bacteria, viruses, fungi, and other microbes from the lungs. About Beyond Cancer: UNO Therapy for Solid TumorsCancer is the second leading cause of death globally, with tumor metastases responsible for approximately 90% of all cancer-related deaths. Current cancer treatment modalities generally include chemotherapy, immunotherapy, radiation, and/or surgery. Nitric oxide at ultra-high concentrations has been reported to show anticancer properties and to serve as a chemosensitizer and radiotherapy enhancer. Based on its current findings, Beyond Cancer is developing treatment protocols using ultra-high nitric oxide concentrations to ablate primary tumors and treat metastatic disease. Forward Looking StatementsThis press release contains “forward-looking statements” concerning inhaled nitric-oxide and the Company’s LungFit® product, including statements with regard to potential clinical and regulatory developments and the expected timing thereof, expected product launch for the Company’s LungFit® product and the timing thereof, and the potential impact on patients and hospitals and anticipated benefits associated with its use. Forward-looking statements include statements about our expectations, beliefs, or intentions regarding our product offerings, business, financial condition, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “anticipates,” “expects,” “intends,” “impacts,” “plans,” “projects,” “believes,” “estimates,” “likely,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: our ability to successfully commercialize LungFit® PH in the U.S. in the planned timeframe; our ability to achieve a CE mark for LungFit® PH in the European Union; the risk that LungFit® PH may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or healthcare reform initiatives; intense competition and rapid technological changes may adversely affect our ability to successfully commercialize LungFit® PH; if we are unable to establish sales and marketing capabilities or enter into agreements with third-parties to market and sell LungFit® PH, we may be unable to generate any revenue; LungFit® PH may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, and the market opportunity for LungFit® PH may be smaller than we estimate; our ability to fund and the results of pre-clinical and clinical trials for our product candidates; obtaining, maintaining and protecting intellectual property utilized by our product and product candidates; our ability to enforce our patents against infringers and to defend our patent portfolio against challenges from third parties; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; obtaining regulatory approval for our product candidates; our short operating history; risks related to the COVID-19 pandemic and their effect on our business; and other risks identified and described in more detail in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on our website. We undertake no obligation to update, and we do not have a policy of updating or revising, these forward-looking statements, except as required by applicable law. CONTACTS: Corey Davis, Ph.D.LifeSci Advisors, LLCCdavis@lifesciadvisors.com (212) 915-2577 BEYOND AIR, INC. AND ITS SUBSIDIARIESCONSOLIDATED BALANCE SHEETS(in thousands, except share data) March 31, 2022 March 31, 2021 ASSETS Current assets Cash and cash equivalents $80,242 $34,631 Restricted cash 9,988 637 Grant receivable 322 425 Other current assets and prepaid expenses 2,393 1,530 Total current assets 92,945 37,223 Licensed right to use technology 1,837 375 Right-of-use lease assets 2,216 1,861 Property and equipment, net 1,995 929 Other assets 207 138 TOTAL ASSETS $99,199 $40,525 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $1,129 $1,325 Accrued expenses 8,374 1,805 Operating lease liability 281 113 Loan payable 927 557 Total current liabilities 10,712 3,800 Operating lease liability 2,079 1,789 Long-term loan, net 200 4,472 Other long-term liabilities 8,000 - Total liabilities 20,990 10,061 Stockholders’ equity Preferred Stock, $0.0001 par value per share: 10,000,000 shares authorized, 0 shares issued and outstanding - - Common Stock, $0.0001 par value per share: 100,000,000 shares authorized, 29,866,173 and 21,828,244 shares issued and outstanding as of March 31, 2022 and 2021, respectively 3 2 Treasury stock (25) (25)Additional paid-in capital 196,269 110,948 Accumulated deficit (123,639) (80,462)Accumulated other comprehensive income 96 - Total stockholders’ equity attributable to Beyond Air, Inc. 72,704 30,464 Non-Controlling Interests 5,505 - Total equity 78,209 30,464 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $99,199 $40,525 BEYOND AIR, INC. AND ITS SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)(in thousands except share data) Year EndedMarch 31, 2022 Year EndedMarch 31, 2021 License revenue $- $873 Operating expenses Research and development (11,802) (12,618)General and administrative (18,408) (10,468)Settlement expense contingent on FDA approval (10,500) - Loss from Operations (40,710) (22,214) Other income (expense) Estimated liability for contingent loss (2,435) - Dividend and interest income 4 17 Interest and finance expense (775) (642)Foreign exchange loss (144) (37)Total other loss (3,350) (661) Net loss before income taxes (44,060) (22,875) Benefit for income taxes - - Net loss $(44,060) $(22,875) Less: Net Loss attributed to non-controlling interests (882) - Net loss attributed to Beyond Air, Inc. $(43,177) $(22,875) Other Comprehensive (Loss) Income, net of tax: Foreign currency translation gain 96 - Comprehensive loss attributed to Beyond Air, Inc. $(43,081) $(22,875) Net loss per share – basic and diluted $(1.68) $(1.27) Weighted average number of shares of common stock outstanding – basic and diluted 25,668,230 18,005,226