nNOS

Commercial demand for LungFit® PH increasing; manufacturing of upgraded devices is ramping up to meet growing demand PMA supplement for the expansion of LungFit PH label to include cardiac surgery accepted for filing and under substantive review by the FDA U.S. pilot trial of LungFit® PRO to treat viral community acquired pneumonia (VCAP) underway; trial will extend over two seasons; the pivotal study remains on track for Winter 2025/26 Phase 1 Study evaluating Beyond Cancer’s ultra-high concentration nitric oxide (UNO) in advanced, R/R unresectable, primary or metastatic cutaneous and subcutaneous solid tumors cleared the first cohort with no reported dose limiting toxicities Reiterated FY 2025 revenue guidance of $12 million to $16 million Conference call scheduled for 4:30 p.m. ET today, February 12th GARDEN CITY, N.Y., Feb. 12, 2024 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR) (“Beyond Air” or the “Company”), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd. (“Beyond Cancer”)), today announced its financial results for the fiscal quarter ended December 31, 2023. “In the third quarter of fiscal year 2024, we reported solid sequential revenue growth of more than 60% compared with the second quarter. This increasing demand for our current LungFit PH system was seen even as we prepared to launch a key software update. As our inventory of upgraded LungFit PH grows, we expect to be able to meet accelerating demand over the next several quarters. This positive commercial traction gives us even more confidence in hitting our fiscal year 2025 sales guidance of $12 to $16 million,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “The PMA supplement for the expansion of the LungFit PH label to include cardiac surgery was accepted for filing by the FDA in late-December and is currently under substantive review. FDA approval for this application should generate even broader use of LungFit PH in U.S. hospitals.” Recent Highlights and Upcoming Milestones LungFit® PH Commercial demand continues to increase for the LungFit PH, as evidenced by a more than 100% increase in filters shipped quarter over quarter This growth trend is expected to continue following the implementation of a much-awaited software update approved by the FDA in September 2023 CE Mark is expected to be received in first half calendar 2024PMA supplement for a cardiac surgery label expansion accepted for filing and under substantive review by the FDARevenue guidance of $12 - $16 million reiterated for the fiscal year ending March 31, 2025 LungFit® PRO Sites opened for a U.S. pilot trial for patients hospitalized with viral community-acquired pneumonia (VCAP) Randomized, double-blind, placebo-controlled trial in 50 patients at up to 10 sitesTop line data expected mid-year 2025 from VCAP study as trial is expected to extend over two seasons Expect to initiate a pivotal trial in the 2025/2026 pneumonia season LungFit® GO Plan to initiate a U.S. trial for patients with nontuberculous mycobacteria (NTM) in calendar year 2025, pending discussion with the FDACOPD pilot trial on hold due to strategic prioritization Beyond Cancer - Solid Tumor Program The ongoing Phase 1 Study evaluating UNO in advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors has cleared the first cohort of 25,000 ppm single dose UNO by the Safety Review Committee, with no reported dose limiting toxicities Enrollment is underway for the 50,000 ppm cohort of the Phase 1 StudyPreparations are being made to enter the Phase Ib portion of the study where UNO is anticipated to be dosed in combination with anti-PD1 First-in-human data presented at the Society for Immunotherapy Conference (SITC) in November 2023 show that a single intratumoral injection of UNO therapy for 5 minutes was safe and well tolerated in patients and showed upregulation of cytotoxic T-cells, T-central memory cells, M1 macrophages, and dendritic cells while downregulating T-regulatory cells and mononuclear-myeloid-derived suppressor cells (M-MDSC) Autism Spectrum Disorder (ASD) Program Plan to initiate a first-in-human study for treatment of ASD in 2025Published pre-clinical data by Hebrew University of Jerusalem (HUJI) in the scientific journal Nitric Oxide in September 2023 which show that the partial inhibition of nNOS reversed the manifestations of ASD phenotype, and reversed nitrosative stress Management Update Duncan Fatkin, Chief Commercial Officer, to leave the company on March 31, 2024; the Company has initiated an executive search for a replacement and will provide updates as appropriate Financial Results for the Fiscal Quarter Ended December 31, 2023 Revenues for the three months ended December 31, 2023 were $0.4 million compared to zero for the quarter ended December 31, 2022. Cost of revenue of $0.7 million was recognized for the three months ended December 31, 2023, compared to $0.1 million for the three months ended December 31, 2022. Research and development expenses for the three months ended December 31, 2023 were $6.8 million as compared to $5.0 million for the three months ended December 31, 2022. The increase of $1.8 million was due primarily to an increase in development costs associated with the pipeline. General and administrative expenses for the three months ended December 31, 2023 and December 31, 2022 were $9.8 million and $8.9 million, respectively. The $0.9 million increase was mainly due to increases in stock based compensation, headcount and salary inflation. Net loss attributed to common stockholders for the three months ended December 31, 2023, was ($16.2) million or a loss of ($0.50) per share, basic and diluted. The Company’s net loss attributed to common stockholders for the three months ended December 31, 2022 was ($12.7) million or a loss of ($0.43) per share, basic and diluted. Total cash burn in the quarter ended December 31, 2023, was $12.7 million, with payments required towards our VCAP study, development of our Gen 2 device, continued in-human trials in Beyond Cancer and advances in our Autism program. The Company raised $5.5 million on its ATM to partially offset the planned cash burn. As of December 31, 2023, the Company had cash, cash equivalents, marketable securities of $31.3 million as well as $5.0 million held on deposit by our contract manufacturer. Conference Call & WebcastMonday, February 12th @ 4:30 PM ET 1-877-407-0784 (Domestic)1-201-689-8560 (International) Call me - https://callme.viavid.com/viavid/?callme=true&passcode=13738837&h=true&info=company-email&r=true&B=6 Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me™ link for instant telephone access to the event. Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1650835&tp_key=79566400ea About Beyond Air®, Inc.Beyond Air is a commercial stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The Company has received FDA approval for its first system, LungFit® PH, for the treatment of term and near-term neonates with hypoxic respiratory failure. 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), and nontuberculous mycobacteria (NTM) among others. Also, the Company has also partnered with The Hebrew University of Jerusalem to advance a pre-clinical program dedicated to the treatment of autism spectrum disorder (ASD) and other neurological disorders. Additionally, Beyond Cancer, Ltd., 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 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. 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 NTMNTM 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 (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. 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. About ASDASD is a serious neurodevelopmental and behavioral disorder, and one of the most disabling conditions and chronic illnesses in children. ASDs include a wide range of developmental disorders that share a core of neurobehavioral deficits manifested by abnormalities in social interactions, deficits in communication, restricted interests, and repetitive behaviors. In 2023, the CDC reported that approximately 1 in 36 children in the U.S. is diagnosed with an ASD. On average, ASD costs an estimated $60,000 a year through childhood, with the bulk of the costs in special services and lost wages related to increased demands on one or both parents. Mothers of children with ASD, who tend to serve as the child’s case manager and advocate, are less likely to work outside the home. On average, they work fewer hours per week and earn 56 percent less than mothers of children with no health limitations and 35 percent less than mothers of children with other disabilities or disorders. The cost of caring for Americans with autism reached $268 billion in 2015 and is expected to rise to $461 billion by 2025 in the absence of more-effective interventions and support across the life span. Forward Looking StatementsThis 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 “appears,” “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 the ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for our product candidates; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; the ability to fund and the results of further pre-clinical studies and clinical trials of our product candidates; 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 Air and Beyond Cancer 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 contactsCorey Davis, Ph.D.LifeSci Advisors, LLCCdavis@lifesciadvisors.com(212) 915-2577 Media contactsKori-Ann TaylorHead of Marketingktaylor@beyondair.net BEYOND AIR, INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS(amounts in thousands, except share and per share data) December 31,2023 March 31,2023 (Unaudited) ASSETS Current assets Cash and cash equivalents $7,971 $29,158 Marketable securities 23,292 16,724 Restricted cash 231 7,610 Accounts receivable 294 - Inventory, net 1,533 1,129 Grant receivable - 420 Other current assets and prepaid expenses 6,118 4,369 Total current assets 39,439 59,410 Licensed right to use technology 1,478 1,632 Right-of-use lease assets 2,229 2,493 Property and equipment, net 8,551 5,003 Other assets 213 212 TOTAL ASSETS $51,911 $68,749 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $3,220 $2,016 Accrued expenses 7,882 16,613 Operating lease liability, current portion 408 376 Loans payable, current portion 130 775 Total current liabilities 11,641 19,780 Operating lease liability, net 2,012 2,321 Long-term debt 14,380 120 Warrant liability 192 - Derivative liability 214 - Other long-term liabilities - 4,500 Total liabilities 28,440 26,721 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, 35,478,123 and 30,738,585 shares issued and outstanding as of December 31, 2023 and March 31, 2023, respectively 4 3 Treasury stock (25) (25)Additional paid-in capital 246,792 217,339 Accumulated deficit (225,990) (179,455)Accumulated other comprehensive income 34 53 Total stockholders’ equity attributable to Beyond Air, Inc 20,814 37,915 Non-controlling interest 2,657 4,113 Total equity 23,471 42,028 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $51,911 $68,749 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 Nine Months Ended December 31, December 31, 2023 2022 2023 2022 Revenue $391 $- $689 $- Cost of revenue 748 68 1,483 247 Gross loss (356) (68) (794) (247) Operating expenses: Research and development (6,838) (5,000) (18,664) (12,679)General and administrative (9,768) (8,941) (30,915) (25,144)Operating expenses (16,606) (13,941) (49,578) (37,823) Operating loss (16,963) (14,010) (50,372) (38,070) Other income (expense) Dividend/interest income and gains on marketable securities 388 271 1,438 388 Interest expense (919) (46) (1,991) (142)Change in fair value of warrant liability 46 - 693 - Change in fair value of derivative liability 135 - 1,147 - Foreign exchange gain and loss 31 286 (3) (108)Estimated liability for contingent loss (11) (248) (609) (248)Other income/ (expense) 35 (52) (42) (71)Total other income (expense) (294) 211 633 (180) Benefit from income taxes - - - - Net loss $(17,258) $(13,798) $(49,739) $(38,250) Less : net loss attributable to non-controlling interest (1,038) (1,051) (3,204) (2,601) Net loss attributable to Beyond Air, Inc. (16,220) (12,747) (46,535) (35,649) Foreign currency translation gain /(loss) (9) (184) (19) 159 Comprehensive loss attributable to Beyond Air, Inc. $(16,229) $(12,931) $(46,554) $(35,490) Net basic and diluted loss per share attributable to Beyond Air, Inc. $(0.50) $(0.43) $(1.46) $(1.19) Weighted average number of shares, outstanding, basic and diluted 32,462,476 29,921,254 31,883,799 29,902,694

– Patient dosing expected to begin mid-to-late Q1 2024 – CHARLESTOWN, Mass., Jan. 16, 2024 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that it has been granted orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for SGT-003, the company’s next-generation Duchenne muscular dystrophy (Duchenne) gene therapy candidate. “Obtaining ODD status for SGT-003, along with Fast Track Designation granted last month, furthers our efforts to meet the ongoing challenge of treating this devastating disease as expeditiously as possible,” said Bo Cumbo, President and Chief Executive Officer at Solid Biosciences. “These designations are important milestones for Solid, supporting the continued development of next-generation therapies for Duchenne.” The company is currently in the process of securing approvals from the institutional review boards (IRB) at the clinical trial sites for the planned Phase 1/2 clinical trial of SGT-003 and expects to commence patient screening shortly thereafter. Patient dosing in the trial is expected to commence in mid-to-late first quarter of 2024. “SGT-003 therapy stands out among other Duchenne gene therapy candidates by leveraging a novel capsid and a muscle tropic vector delivering a microdystrophin that incorporates a neuronal Nitric Oxide Synthase (nNOS) binding domain. These attributes among others, have the potential to yield both more potent transduction than historical approaches, and a microdystrophin that may be able to more fully address muscle resiliency,” said Gabriel Brooks, M.D., Chief Medical Officer at Solid Biosciences. “Obtaining ODD status is an exciting development that we believe will aid our efforts to bring advanced treatment options to those patients affected by Duchenne.” About SGT-003SGT-003 uses a proprietary, rationally designed capsid (AAV-SLB101) to deliver a DNA sequence encoding a shortened form of the dystrophin protein (microdystrophin), containing the R16-R17 nNOS binding domain. Preclinical data suggests this may be important for both muscular function and durability of benefit in patients. About Orphan Drug DesignationThe FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended to treat a rare disease or condition that affects fewer than 200,000 people in the U.S. Orphan drug designation provides certain benefits, including specified financial incentives, to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval. About DMDDuchenne is a genetic muscle-wasting disease predominantly affecting boys, with symptoms usually appearing between three and five years of age. Duchenne is a progressive, irreversible, and ultimately fatal disease that affects approximately one in every 3,500 to 5,000 live male births and has an estimated prevalence of 5,000 to 15,000 cases in the United States alone.About Solid BiosciencesSolid Biosciences is a life sciences company focused on advancing a portfolio of gene therapy candidates and neuromuscular and cardiac programs, including SGT-003, for the treatment of Duchenne muscular dystrophy (Duchenne), SGT-501 for the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT), AVB-401 for the treatment of BAG3-mediated dilated cardiomyopathy, AVB-202-TT for the treatment of Friedreich’s ataxia, and additional assets for the treatment of fatal cardiac diseases. Solid is advancing its diverse pipeline across rare neuromuscular and cardiac diseases, bringing together experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted, Solid’s mandate is to improve the daily lives of patients living with these devastating diseases. For more information, please visit www.solidbio.com. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding future expectations, plans and prospects for the company; the ability to successfully achieve and execute on the company’s priorities and achieve key clinical milestones; the company’s SGT-003 program, including securing IRB approval at clinical sites, initiating patient screening and initiating dosing, and the potential benefits of SGT-003; the potential benefits of ODD status; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the ability to recognize the anticipated benefits of Solid’s acquisition of AavantiBio; the company’s ability to advance SGT-003, SGT-501, AVB-401, AVB-202-TT and other preclinical programs and capsid libraries on the timelines expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; replicate in clinical trials positive results found in preclinical studies of the company’s product candidates; obtain, maintain or protect intellectual property rights related to its product candidates; compete successfully with other companies that are seeking to develop Duchenne and other neuromuscular and cardiac treatments and gene therapies; manage expenses; and raise the substantial additional capital needed, on the timeline necessary, to continue development of SGT-003, SGT-501, AVB-401, AVB-202-TT and other candidates, achieve its other business objectives and continue as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company's views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so. Solid Biosciences Contact:Leah MonteiroVP, Investor Relations and Communications617-766-3430lmonteiro@solidbio.com

Provides fiscal year 2025 revenue guidance of $12 - $16 million US pilot trial of LungFit® PRO to treat viral community acquired pneumonia (VCAP) underway with data expected mid-calendar 2024 Beyond Cancer presents positive first-in-human data for intratumoral administration of ultra-high concentration nitric oxide (UNO) therapy demonstrating safety and evidence of immune system activation at the Society for Immunotherapy Conference (SITC) Submitted PMA supplement to FDA for the expansion of LungFit PH label to include cardiac surgery; approval anticipated in second half calendar 2024 LungFit PH granted Innovative Technology contract from Vizient, Inc., the nation’s largest provider-driven health care performance improvement company Entered into an agreement with Getz Healthcare to commercialize the LungFit PH device in certain countries across the Asia-Pacific region Conference call scheduled for 4:30 p.m. ET today, November 13th GARDEN CITY, N.Y., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR) (“Beyond Air” or the “Company”), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd. (“Beyond Cancer”)), today announced its financial results for the fiscal quarter ended September 30, 2023. “The Beyond Air and Beyond Cancer teams continue to execute. In the last three months, we have made significant strides in the US hospital market with LungFit PH, licensed LungFit PH in certain Asian markets, submitted a PMA supplement to the FDA for cardiac surgery, presented preclinical and human data for treatment of solid tumors with UNO and began the United States VCAP study,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “Market confidence in our superior LungFit PH technology continues to grow along with our market penetration and opportunities. I am proud of our progress and want to thank our customers who gave us the opportunity to succeed over the past year. At the American Academy of Respiratory Care (AARC) last week there was great enthusiasm around our enhanced LungFit PH system which gives us confidence in our fiscal 2025 revenue guidance as well as our belief that LungFit PH will become the dominant product in the market”. Recent Highlights and Upcoming Milestones LungFit® PH Provided revenue guidance of $12 - $16 million for the fiscal year ending March 31, 2025Entered into an agreement with Getz Healthcare to commercialize the LungFit PH device in certain countries across the Asia-Pacific region, paving the way for an ex-U.S. launchReceived an Innovative Technology contract from Vizient Inc. based on recommendations by hospital experts who serve on Vizient’s customer-led councilsCE Mark anticipated to be received in first half calendar 2024Submitted a PMA supplement to the FDA for a cardiac surgery label expansion; approval anticipated in calendar year 2024 LungFit® PRO Initiated the process for opening sites for a U.S. pilot trial for patients hospitalized with viral community-acquired pneumonia (VCAP)Randomized, double-blind, placebo-controlled trial in 50 patients at 10 sitesTop line data expected mid-year 2024 from VCAP study LungFit® GO Plan to initiate a U.S. trial for patients with nontuberculous mycobacteria (NTM) in calendar year 2025, pending discussion with the FDACOPD pilot trial on hold due to strategic prioritization Beyond Cancer - Solid Tumor Program First-in-human data presented at the Society for Immunotherapy Conference (SITC) in November 2023 show that a single intratumoral injection of UNO therapy for 5 minutes was safe and well tolerated in patients and showed upregulation of cytotoxic T-cells, T-central memory cells, M1 macrophages, and dendritic cells while downregulating T-regulatory cells and mononuclear-myeloid-derived suppressor cells (M-MDSC)Published pre-clinical data demonstrating that UNO therapy combined with anti-mPD-1 has a synergistic immune response resulting in a significant improvement in tumor regression rates and survival in micePooled data analysis of combination studies with 50,000 or 100,000 ppm UNO and anti-mPD-1 demonstrated more than a doubling in survival versus anti-mPD-1 alone, presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Autism Spectrum Disorder (ASD) Program Announced pre-clinical data demonstrating a therapeutic effect for at least 10 days after a single subcutaneous injection of an extended-release selective neuronal nitric oxide synthase (nNOS) inhibitorPlan to initiate a first-in-human study for treatment of ASD in 2025 Financial Results for the Fiscal Quarter Ended September 30, 2023 Revenues for the three months ended September 30, 2023 were $0.24 million compared to zero for the quarter ended September 30, 2022. Cost of revenue of $0.4 million was recognized for the three months ended September 30, 2023, compared to $0.2 million for the three months ended September 30, 2022. Research and development expenses for the three months ended September 30, 2023 were $7.1 million as compared to $4.5 million for the three months ended September 30, 2022. The additional $2.7 million was due primarily to an increase in stock-based compensation, salaries, and development costs associated with the pipeline. General and administrative expenses for the three months ended September 30, 2023 and September 30, 2022 were $10.2 million and $8.0 million, respectively. The $2.2m increase was mainly due to stock based compensation, professional fees and salaries. Net loss attributed to common stockholders for the three months ended September 30, 2023, was ($16.2) million or a loss of ($0.51) per share, basic and diluted. The Company’s net loss attributed to common stockholders for the three months ended September 30, 2022 was ($12.0) million or a loss of ($0.40) per share, basic and diluted. Total cash burn in the quarter ended September 30, 2023, was $16.5 million, including $6.4 million in one-time payments which had previously been disclosed and accrued. Aside from these one-time payments, cash burn in the quarter was $10.1 million which is in line with our guidance of approximately $10 million per quarter. As of September 30, 2023, the Company had cash, restricted cash, cash equivalents and marketable securities of $43.9 million. Conference Call & WebcastMonday, November 13th @ 4:30 PM ET 1-877-407-0784 (Domestic)1-201-689-8560 (International) Call me - https://callme.viavid.com/viavid/?callme=true&passcode=13738837&h=true&info=company-email&r=true&B=6 Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me™ link for instant telephone access to the event. Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1640134&tp_key=2d5ff9123d About Beyond Air®, Inc.Beyond Air is a commercial stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors. The Company has received FDA approval for its first system, LungFit® PH, for the treatment of term and near-term neonates with hypoxic respiratory failure. Beyond Air is currently advancing its other LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19), and nontuberculous mycobacteria (NTM). The Company has also partnered with The Hebrew University of Jerusalem to advance a pre-clinical program dedicated to the treatment of autism spectrum disorder (ASD) and other neurological disorders. Beyond Cancer, Ltd., 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 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. 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 NTMNTM 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 (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. 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. About ASDASD is a serious neurodevelopmental and behavioral disorder, and one of the most disabling conditions and chronic illnesses in children. ASDs include a wide range of developmental disorders that share a core of neurobehavioral deficits manifested by abnormalities in social interactions, deficits in communication, restricted interests, and repetitive behaviors. In 2023, the CDC reported that approximately 1 in 36 children in the U.S. is diagnosed with an ASD. On average, ASD costs an estimated $60,000 a year through childhood, with the bulk of the costs in special services and lost wages related to increased demands on one or both parents. Mothers of children with ASD, who tend to serve as the child’s case manager and advocate, are less likely to work outside the home. On average, they work fewer hours per week and earn 56 percent less than mothers of children with no health limitations and 35 percent less than mothers of children with other disabilities or disorders. The cost of caring for Americans with autism reached $268 billion in 2015 and is expected to rise to $461 billion by 2025 in the absence of more-effective interventions and support across the life span. Forward Looking StatementsThis 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 “appears,” “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 the ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for our product candidates; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; the ability to fund and the results of further pre-clinical studies and clinical trials of our product candidates; 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 Air and Beyond Cancer 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 BargerHead of Investor Relationsebarger@beyondair.net Corey Davis, Ph.D.LifeSci Advisors, LLCCdavis@lifesciadvisors.com (212) 915-2577 Media contacts Kori-Ann TaylorHead of Marketingktaylor@beyondair.net BEYOND AIR, INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS(amounts in thousands, except share and per share data) September 30, 2023 March 31, 2023 (Unaudited) ASSETS Current assets Cash and cash equivalents$13,179 $29,158 Marketable securities 25,463 16,724 Restricted cash 5,231 10,129 Accounts receivable 205 - Inventory, net 1,574 1,129 Grant receivable - 420 Other current assets and prepaid expenses 1,481 1,850 Total current assets 47,134 59,410 Licensed right to use technology 1,529 1,632 Right-of-use lease assets 2,294 2,493 Property and equipment, net 6,824 5,003 Other assets 224 212 TOTAL ASSETS$58,005 $68,749 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable$3,292 $2,016 Accrued expenses 8,496 16,613 Operating lease liability, current portion 391 376 Loans payable, current portion 275 775 Total current liabilities 12,454 19,780 Operating lease liability, net 2,087 2,321 Long-term debt 14,044 120 Warrant Liability 238 - Derivative liability 349 - Other long-term liabilities - 4,500 Total liabilities 29,173 26,721 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, 31,972,434 and 30,738,585 shares issued and outstanding as of September 30, 2023 and March 31, 2023, respectively 3 3 Treasury stock (25) (25)Additional paid-in capital 235,495 217,339 Accumulated deficit (209,770) (179,455)Accumulated other comprehensive income 43 53 Total stockholders’ equity attributable to Beyond Air, Inc 25,746 37,915 Non-controlling interests 3,085 4,113 Total equity 28,831 42,028 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY$58,005 $68,749 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, 2023 2022 2023 2022 Revenue$239 $- $298 $- Cost of revenue 432 179 735 179 Gross loss (193) (179) (437) (179) Operating expenses: Research and development (7,130) (4,452) (11,826) (7,678)General and administrative (10,211) (7,990) (21,147) (16,203)Operating expenses (17,342) (12,442) (32,972) (23,882) Operating loss (17,535) (12,621) (33,410) (24,061) Other income (loss) Dividend/interest income and gains on marketable securities 641 1,050 - Interest expense (914) (48) (1,072) (96)Change in fair value of warrant liability 324 - 647 - Change in fair value of derivative liability 500 - 1,012 - Foreign exchange loss (42) (217) (34) (394)Estimated liability for contingent loss (400) - (598) - Other income / (expense) - 88 (77) 99 Total other income (expense) 109 (177) 929 (391) Benefit from income taxes - - - - Net loss$(17,426) $(12,797) $(32,481) $(24,452) Less : net loss attributable to non-controlling interests (1,205) (830) (2,165) (1,550) Net loss attributable to Beyond Air, Inc. (16,220) (11,968) (30,315) (22,902) Foreign currency translation gain/(loss) (35) 171 (9) 343 Comprehensive loss attributable to Beyond Air, Inc.$(16,255) $(11,797) $(30,325) $(22,559) Net basic and diluted loss per share attributable to Beyond Air, Inc.$(0.51) $(0.40) $(0.96) $(0.77) Weighted average number of shares, outstanding, basic and diluted 31,800,492 29,898,825 31,592,880 29,893,414