Science. Equipment. Medicine Ltd.

Commercial launch underway for LungFit® PH for the treatment of term and near-term neonates with hypoxic respiratory failure, which received FDA approval on June 28, 2022 Presented favorable safety, tolerability, and efficacy results from the pilot study of at-home LungFit® GO for nontuberculous mycobacterial (NTM) lung infection at the American College of Chest Physicians (CHEST) Preclinical data showing prolonged survival for ultra-high concentration nitric oxide (UNO) in combination with anti-PD1 to be unveiled at the Society for Immunotherapy of Cancer (SITC) on November 10, 2022 Conference call scheduled for 4:30 p.m. ET today, November 8th GARDEN CITY, N.Y., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR) a 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 second fiscal quarter ended September 30, 2022. “Our commercial team continues to successfully execute the initial phase of the LungFit PH launch following FDA approval in late-June 2022. Over the past few months, the demand for product evaluations and demonstrations have exceeded expectations. We are pleased to report that participating hospital staff have provided a steady flow of positive feedback,” commented Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “In addition, we are planning to submit a PMA supplement for an expanded cardiac label for the LungFit® PH system to the FDA.” “During the quarter, we presented positive data that support the development programs for the LungFit system using high dose NO as a potential treatment for several indications. At the CHEST Annual Meeting 2022 we presented favorable safety, tolerability, and efficany data for our LungFit GO pilot at-home study of patients with severe, treatment refractory, NTM lung disease, which further support development of intermittent high dose NO for the treatment of NTM as well as other chronic respiratory infections. We believe this study breaks new ground in the development of NO therapy by successfully showing the ability of our at-home NO generator-based system to be used safely and consistently by this patient population in a real-world setting.” “Additionally, we are excited to announce that Beyond Cancer’s first-in-human Phase 1 study of UNO for the treatment of solid tumors designed to assess safety and efficacy is moving along after the first patient was treated in August 2022. We expect to announce topline data from the Phase 1 study in the first half of 2023,” concluded Mr. Lisi. Recent Highlights and Upcoming Milestones LungFit® PH Continue progress with limited release phase of commercial launch, making it the first and only nitric oxide generator, delivery and monitoring system available in the U.S., following FDA approval on June 28, 2022 to treat term and near-term neonates with hypoxic respiratory failureCE Mark anticipated to be received at the end of calendar year 2022, which is expected to be followed by an international commercial partnershipExpect to submit a PMA supplement for a cardiac label expansion for LungFit® PH to the FDA prior to year-end 2022 LungFit® PRO Presented positive data from the LungFit® PRO pilot study of high-concentration inhaled NO in Viral Community-Acquired Pneumonia (VCAP), including COVID-19, which show a strong safety profile and statistically significant results on key efficacy endpoints in the iNO treatment group compared to standard supportive treatment (SST)The Annals of the American Thoracic Society published a detailed review of a third pilot study of inhaled NO in bronchiolitis patients under the age of 12 months, including an overview of the study design and previously announced results (click here)Plan to initiate a U.S. trial for patients hospitalized with VCAP, including COVID-19, in the fourth quarter of calendar year 2023, pending discussion with the FDA LungFit® GO Presented positive safety, tolerability, and efficacy data from the LungFit GO pilot at-home study of patients with severe, treatment refractory, NTM lung disease at the American College of Chest Physicians (CHEST) Annual Meeting 2022Expect to initiate a pilot study in the fourth quarter of calendar 2023 in COPD patients who are hospitalized due to an exacerbation Beyond Cancer’s Solid Tumor Program Pre-clinical data for ultra-high concentration nitric oxide therapy to be presented at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 10, 2022 which show benefits of NO therapy in combination with anti-PD1 over anti-PD1 monotherapy with respect to tumor regression and survivalBeyond Air 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 Financial Results for the fiscal quarter ended September 30, 2022 Research and development expenses for the fiscal quarter ended September 30, 2022 were $4.5 million, compared with $2.8 million for the fiscal quarter ended September 30, 2021. The increase is primarily attributable to increased spending on UNO. General and administrative expenses for the fiscal quarter ended September 30, 2022 increased to $8 million, compared with $3.4 million for the fiscal quarter ended September 30, 2021. The increase is mainly attributable to the staffing and scaling up of Beyond Cancer in both the U.S. and Israel, as well as continued investments necessary to support the commercial launch of LungFit® PH in the U.S. Other income and expense for the fiscal quarter ended September 30, 2022 was a loss of $0.2 million, compared with a loss of $2.5 million for the fiscal quarter ended September 30, 2021. For the fiscal quarter ended September 30, 2022, Beyond Air, Inc. (the “Company”) had a net loss of $12.8 million, of which $12.0 million, or ($0.40) per share, was attributable to the shareholders of Beyond Air, compared with a net loss of $8.7 million, or ($0.36) per share, for the fiscal quarter ended September 30, 2021. As of September 30, 2022, the Company reported cash and cash equivalents, marketable securities, and restricted cash of $72.5 million. Total cash burn in the quarter ended September 30, 2022 was $10.4 million, just above the quarterly cash burn guidance of $8.0 – 10.0 million, and includes a $2.5 million non-recurring payment. The Company expects to see the quarterly average cash burn during the fiscal year 2023 to fall within this range. Through first half of our fiscal year ended September 30, 2022, total cash burn was $17.9 million. Conference Call & WebcastTuesday, November 8th@ 4:30 PM ETDomestic:1- 844-825-9789International:1- 412-317-5180Passcode:10172080Webcast:https://viavid.webcasts.com/starthere.jsp?ei=1576040&tp_key=65a361d2ed or the Events page of the Company’s website (click here) About Beyond Air®, Inc.Beyond Air is a 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 www.beyondair.net. 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 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 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 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 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 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, 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 www.beyondcancer.com. About 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. 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 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: Edward BargerHead of Investor Relationsebarger@beyondair.net Corey Davis, Ph.D.LifeSci Advisors, LLCCdavis@lifesciadvisors.com (212) 915-2577 BEYOND AIR, INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS(amounts in thousands, except share and per share data) September 30, 2022 March 31, 2022 (Unaudited) ASSETS Current assets Cash and cash equivalents$29,829 $80,242 Marketable Securities 32,617 - Restricted cash 10,106 9,988 Inventory, net 711 350 Grant receivable 235 322 Other current assets and prepaid expenses 1,581 2,044 Total current assets 75,078 92,945 Licensed right to use technology 1,734 1,837 Right-of-use lease assets 2,265 2,216 Property and equipment, net 2,757 1,995 Other assets 205 207 TOTAL ASSETS$82,039 $99,199 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable$2,006 $1,129 Accrued expenses 8,934 8,374 Operating lease liability 348 281 Loan payable, current portion 310 927 Total current liabilities 11,598 10,712 Long-term liabilities Operating lease liability 2,090 2,079 Long-term debt, net 200 200 Other long-term liabilities 4,500 8,000 Total liabilities 18,387 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, 29,911,207 and 29,886,173 shares issued and outstanding as of September 30, 2022 and March 31, 2022, respectively 3 3 Treasury stock (25) (25)Additional paid-in capital 204,930 196,269 Accumulated deficit (146,541) (123,639)Accumulated other comprehensive income 438 96 Total stockholders’ equity attributable to Beyond Air, Inc 58,805 72,704 Non-controlling interests 4,847 5,505 Total Equity 63,652 78,209 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY$82,039 $99,199 BEYOND AIR, INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(amounts in thousands, except share and per share data)(UNAUDITED) For the Three Months Ended For the Six Months Ended September 30, September 30, 2022 2021 2022 2021 Revenue$- $- $- $- Cost of Revenue 179 - 179 - Gross Profit / (Loss) (179) - (179) - Operating expenses: Research and development 4,452 2,807 7,678 5,548 General and administrative 7,990 3,395 16,203 7,245 Operating expenses 12,442 6,201 23,882 12,793 Operating loss (12,621) (6,201) (24,061) (12,793) Other income (loss) Interest expense (48) (161) (96) (323)Foreign exchange gain / (loss) (217) 0 (394) 9 Other income / (expense) 88 (2,329) 99 (2,328)Total other expense (177) (2,490) (391) (2,642) Benefit from income taxes - - - - Net loss$(12,797) $(8,692) $(24,452) $(15,435) Less : net loss attributable to non-controlling interests (830) - (1,550) - Net loss attributable to Beyond Air, Inc. (11,968) (8,692) (22,902) (15,435) Foreign currency translation gain 171 - 343 - Comprehensive loss attributable to Beyond Air, Inc.$(11,797) $(8,692) $(22,559) $(15,435) Net basic and diluted loss per share attributable to Beyond Air, Inc.$(0.40) $(0.36) $(0.77) $(0.67) Weighted average number of shares, outstanding, basic and diluted 29,898,825 24,165,965 29,893,414 23,061,667

Developed as the first stand-alone standard of care first-line therapy for NTM disease caused by Mycobacterium avium complex (MAC) infection, RHB-204 is currently undergoing a Phase 3 study in the U.S. EMA Orphan Drug Designation provides eligibility for 10 years post-approval EU market exclusivity. U.S. FDA Fast Track, Orphan and QIDP priority designations, previously granted to RHB-204, extend U.S. post-approval market exclusivity to a total of 12 years The Company is advancing discussions with prospective partners for RHB-204 across multiple territories TEL AVIV, Israel and RALEIGH, N.C., Aug. 17, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the European Commission has granted Orphan Drug Designation to RHB-2041 for the treatment of nontuberculous mycobacteria (NTM) disease, following a positive opinion recommendation by the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP). The EMA grants Orphan status to treatments of a life-threatening or chronically debilitating condition that is rare (affecting not more than five in 10,000 people in the European Union)2. Orphan Designation provides for free protocol assistance (scientific advice from the EMA), potential reductions in fees, and eligibility for 10 years post-launch market exclusivity. "NTM infections are increasing across the world and they are notoriously difficult to treat. There are no approved first-line stand-alone therapies in the U.S, EU, and Japan, highlighting the significant need for new options to treat this challenging and debilitating infectious disease," said Patricia Anderson, RedHill's SVP Regulatory Affairs. "The granting of EU Orphan Designation is important and brings significant developmental benefits, in addition to the provision for a potential 10 years of EU post-approval market exclusivity, which adds to the strong exclusivity secured in the U.S." A U.S. Phase 3 study is ongoing to evaluate the efficacy and safety of RHB-204 in adults with pulmonary NTM disease caused by Mycobacterium avium complex (MAC) infection (NCT04616924). The study protocol provides for 6 months co-primary endpoint of sputum culture conversion (SCC) and clinical outcome (patient-reported outcomes - PRO) in a randomized placebo-controlled design, followed by open label active treatment with RHB-204 for 12 months from conversion. The Company is advancing discussions with prospective partners for RHB-204 across multiple territories. About Pulmonary Nontuberculous Mycobacteria (NTM) Infections Pulmonary nontuberculous mycobacteria (NTM) disease is a chronic and debilitating lung disease caused by ubiquitous environmental bacteria, found in soil as well as natural and engineered water systems. The most common NTM symptoms include persistent cough, fever, weight loss, chest pain, and blood in sputum3. NTM infections can lead to recurring cases of bronchitis and pneumonia and can, in some cases, lead to respiratory failure4. Although rare, the incidence and prevalence of pulmonary NTM disease are increasing in many areas of the world5. There were an estimated 110,000 pulmonary NTM disease patients in the U.S. in 20176 and an estimated 28,000 in the EU. Pulmonary manifestations account for 80-90% of all NTM-associated diseases7, and approximately 80% of pulmonary NTM infections are caused by Mycobacterium avium complex (MAC)8. Treatment of NTM infection can be difficult with guidelines recommending that MAC infection be treated with a multi-drug regimen for treatment, with at least three antimicrobials, for at least 12 months9. There is no FDA- or EMA-approved first-line standard-of-care combination therapy. Many patients fail current therapy, and more than half will have either recurring disease or a new infection after completing treatment10. Thus, new treatment options for NTM are needed. About RHB-204 RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, developed for the treatment of pulmonary NTM infections caused by Mycobacterium avium Complex (MAC). RHB-204 was granted FDA Fast Track and Orphan Drug Designation, in addition to QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. post-approval U.S. market exclusivity to a potential total of 12 years. RHB-204 has additionally been granted EU Orphan Designation, providing eligibility for 10 years EU post-approval market exclusivity. RHB-204 is also covered by U.S. patents which extend patent protection until 2029 and a pending U.S. patent application which, if allowed, could extend RHB-204 patent protection until 2041. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults11, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® for the treatment of travelers' diarrhea in adults12. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first -in -class oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for hospitalized COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 ( upamostat), an oral serine protease inhibitor in a Phase 3-stage study as treatment for non-hospitalized symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-102 , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. More information about the Company is available at twitter.com/RedHillBio. This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company will not initiate the Phase 3 clinical study in all or part of the sites in the U.S. or will be delayed; the risk that the U.S. Phase 3 clinical study evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, Movantik® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 17, 2022. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. 1 RHB-204 is an investigational new drug, not available for commercial distribution. 2 3 Kim RD, et al. Pulmonary Nontuberculous Mycobacterial Disease. Prospective Study of a Distinct Preexisting Syndrome Am J Respir Crit Care Med. 2008; 178(10):1066–74. 4 The American Lung Association, 2020. 5 Winthrop KL, et al. Incidence and Prevalence of Nontuberculous Mycobacterial Lung Disease in a Large U.S. Managed Care Health Plan, 2008-2015. Ann Am Thorac Soc. 2020 Feb;17(2):178-185. 6 Foster|Rosenblatt, 2017 7 Griffith DE, et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases Am J Respir Crit Care Med. 2007;175(4):367-416. 8 Prevots DR et al. Nontuberculous mycobacterial lung disease prevalence at four integrated health care delivery systems. Am J Respir Crit Care Med 2010; 182:970-76; Winthrop KL, et al. Pulmonary nontuberculous mycobacterial disease prevalence and clinical features: an emerging public health disease. Am J Respir Crit Care Med 2010; 182: 977-82 9 Daley CL, et al. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline: Executive Summary. Clinical Infectious Diseases. Ciaa241, . 10 Henkle E, et al. Patient-Centered Research Priorities for Pulmonary Nontuberculous Mycobacteria (NTM) Infection. An NTM Research Consortium Workshop Report Annals of the American Thoracic Society 2016; S379-84. 11 Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: . 12 Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: . Logo - SOURCE RedHill Biopharma Ltd.

Initiated U.S. commercial launch of LungFit® PH for the treatment of term and near-term neonates with hypoxic respiratory failure, which received FDA approval on June 28, 2022 Will present data from the pilot study of at-home LungFit® GO for nontuberculous mycobacterial lung infection at the American College of Chest Physicians (CHEST) in October 2022 Anticipate dosing the first patient in the Phase I trial of ultra-high concentration gaseous NO (UNO) being conducted by Beyond Cancer™, the Company’s oncology affiliate, during the current quarter Conference call scheduled for 4:30 p.m. ET today, August 11th GARDEN CITY, N.Y., Aug. 11, 2022 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a 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 first fiscal quarter ended June 30, 2022. “Our sales team has quickly ramped up the initial phase of the commercial launch for the LungFit® PH, which received FDA approval in late-June. This initial activity includes conducting product demonstrations at numerous U.S. hospitals, which we are pleased to report have generated positive feedback from the participating hospital staff. We are also highly encouraged by the feedback received during the medical conferences our team has attended since approval. The early success of this program and initial feedback received is expected to put us on schedule to equip the first small group of hospitals with LungFit® PH systems over the next several months. We look forward to the upcoming American Association for Respiratory Care (AARC) in November and encourage investors to come see us in New Orleans,” commented Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “We continue to expect to receive CE Mark for LungFit® PH in Europe during the second half of calendar year 2022. In addition, we are planning to submit a PMA supplement for an expanded cardiac label for the LungFit® PH system to the U.S. FDA.” Recent Highlights and Upcoming Milestones LungFit® PH Received U.S. FDA approval on June 28, 2022 to treat term and near-term neonates with hypoxic respiratory failureInitiated limited release phase of commercial launch, making it the first and only nitric oxide generator, delivery and monitoring system available in the U.S.; and already conducted numerous on-site demonstrationsCE Mark anticipated to be received in the second half of calendar year 2022, which is expected to be followed by an international commercial partnershipExpect to submit a PMA supplement for an expanded cardiac label for the LungFit® PH to the U.S. FDA prior to year-end 2022 LungFit® PRO Planning 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 FDAWill present data in a poster session at an upcoming conference this Fall from the Company’s recently completed VCAP study LungFit® GO Will present data from the pilot study of at-home LungFit® GO for nontuberculous mycobacterial (NTM) lung infection at CHEST 2022 in Nashville on October 17, 2022Expect to initiate a pilot study in COPD patients who are hospitalized due to an exacerbation in the fourth quarter of calendar 2023 Beyond Cancer’s Solid Tumor Program Anticipate dosing the first patient in a first-in-human Phase 1 study to assess the safety and efficacy of ultra-high concentration nitric oxide for the treatment of solid tumors in the current quarter Financial Results for the fiscal quarter ended June 30, 2022 Research and development expenses for the fiscal quarter ended June 30, 2022 were $3.2 million, compared with $2.7 million for the fiscal quarter ended June 30, 2021. General and administrative expenses for the fiscal quarter ended June 30, 2022 increased to $8.2 million, compared with $3.9 million for the fiscal quarter ended June 30, 2021. The increase is mainly attributable to the staffing and scaling up of Beyond Cancer in both the U.S. and Israel, as well as continued investments necessary to support the commercial launch of LungFit® PH in the U.S. Other income and expense for the fiscal quarter ended June 30, 2022 was a loss of $0.2 million, compared with a loss of $0.2 million for the fiscal quarter ended June 30, 2021. For the fiscal quarter ended June 30, 2022, the Company had a net loss of $11.7 million, of which $10.9 million, or ($0.37) per share, was attributable to the shareholders of Beyond Air, compared with a net loss of $6.7 million, or ($0.31) per share, for the fiscal quarter ended June 30, 2021. As of June 30, 2022, the Company reported cash and cash equivalents of $72.8 million. Net cash used in operations, including Beyond Cancer, was $6.8 million in the fiscal quarter ended June 30, 2022. This is below the quarterly cash burn guidance of $8.0 – 10.0 million. The Company expects to see the quarterly average cash burn during the fiscal year 2023 to fall within this range. Conference Call & WebcastThursday, August 11th @ 4:30 PM ETDomestic: 1-866-652-5200 International: 1-412-317-6060 Passcode: 10169266Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1560124&tp_key=09d6f2fe5dor the Events page of the Company’s website (click here) About Beyond Air, Inc.Beyond Air, Inc. is a medical device and biopharmaceutical company dedicated to harnessing the power of nitric oxide (NO) 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 community-acquired viral 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 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® PH is approved for commercial use only in the United States of America. 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 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 SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS(amounts in thousands, except share and per share data) June 30, 2022 March 31, 2022 (Unaudited) ASSETS Current assets Cash and cash equivalents $72,773 $80,242 Restricted cash 9,989 9,988 Inventory, net 686 350 Grant receivable 479 322 Other current assets and prepaid expenses 1,497 2,044 Total current assets 85,424 92,945 Licensed right to use technology 1,785 1,837 Right-of-use lease assets 2,354 2,216 Property and equipment, net 2,132 1,995 Other assets 209 207 TOTAL ASSETS $91,904 $99,199 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $1,038 $1,129 Accrued expenses 8,213 8,374 Operating lease liability 290 281 Loan payable, current portion 619 927 Total current liabilities 10,160 10,712 Long-term liabilities Operating lease liability 2,193 2,079 Long-term debt, net 200 200 Other long-term liabilities 8,000 8,000 Total liabilities 20,553 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, 29,888,004 and 29,886,173 shares issued and outstanding as of June 30, 2022 and March 31, 2022, respectively 3 3 Treasury stock (25) (25)Additional paid-in capital 200,448 196,269 Accumulated deficit (134,573) (123,639)Accumulated other comprehensive income 268 96 Total stockholders’ equity attributable to Beyond Air, Inc 66,120 72,704 Non-controlling interests 5,230 5,505 Total Equity 71,351 78,209 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $91,904 $99,199 BEYOND AIR, INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)(amounts in thousands, except share and per share data)(UNAUDITED) For the Three Months Ended June 30, 2022 2021 License revenues $- $- Operating expenses: Research and development 3,226 2,741 General and administrative 8,214 3,850 Operating expenses 11,440 6,591 Operating loss (11,440) (6,591) Other income (expense) Interest expense (48) (162)Foreign exchange gain / (loss) (177) 10 Other income / (expense) 10 1 Total other expense (215) (152) Benefit for income taxes - - Net Loss $(11,654) $(6,743) Less : net loss attributable to non-controlling interests (720) - Net loss attributable to Beyond Air, Inc. $(10,934) $(6,743) Foreign currency translation gain 172 - Comprehensive loss attributable to Beyond Air, Inc. $(10,762) $(6,743) Net basic and diluted loss per share attributable to Beyond Air, Inc. $(0.37) $(0.31) Weighted average number of shares, outstanding basic and diluted 29,888,004 21,945,235