GARDEN CITY, N.Y. and REHOVOT, Israel, Feb. 25, 2020 — Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled Nitric Oxide (NO) for the treatment of patients with respiratory conditions including serious lung infections and pulmonary hypertension, will host an analyst day in New York City on March 5, 2020.
The event will feature presentations by Beyond Air’s senior management team who will discuss their proprietary nitric oxide generator and delivery system, LungFit™ for the treatment of patients with Persistent Pulmonary Hypertension of the Newborn (PPHN), Bronchiolitis and Nontuberculous Mycobacteria (NTM). The meeting will also feature a panel of Key Opinion Leaders (KOLs), including Andrew R. Colin, M.D., Miller School of Medicine, University of Miami, Panayot G. Filipov, M.D., Maimonides Infants and Children’s Hospital, and Stacey L. Martiniano, M.D., University of Colorado and Children’s Hospital Colorado, who will answer questions regarding the current treatment landscape and unmet medical needs for these indications.
Beyond Air’s management team will also give an in-depth overview of the different indications for which LungFit™ is being developed. LungFit™ PH, is a next-generation phasic flow nitric oxide delivery system designed for the treatment of PPHN in the hospital setting. The Company expects to submit a PMA to the FDA for this indication in the next few months. Management will also be discussing LungFit™ BRO for the treatment of bronchiolitis, expected to launch in the Fall of 2022 and LungFit™ NTM for the treatment of NTM, expected to launch late in 2024.
This event is intended for institutional investors, sell-side analysts, and business development professionals. Please RSVP in advance if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay will be accessible via the link here.
Andrew R. Colin, M.D., serves as a Professor of Pediatrics and Director of the Division of Pediatric Pulmonology at the Miller School of Medicine, University of Miami. He served as Associate-Chief of a Technion-affiliated Department of Pediatrics in Haifa, Israel. In 1990, he joined the faculty of Boston Children`s Hospital at Harvard Medical School. He served as Clinical Director of the Division of Respiratory Diseases and also served as Associate Professor at Harvard Medical School. He serves as a Member of the Scientific Advisory Board at Beyond Air Inc. His expertise includes: asthma, cystic fibrosis, structural and functional development of the respiratory system and related problems, including lung diseases of prematurity, pediatric bronchoscopy and more. Dr. Colin participated in research and teaching and received the Klaus Peter International Teaching Award of Harvard Medical School and was the first recipient of the Andrew A. Colin Teaching Award. He is certified by the American Board of Pediatrics in Pediatrics and Pediatric Pulmonology. He has participated in over 20 studies in his field including ones sponsored by the NIH, Genentech, GlaxoSmithKline and the Cystic Fibrosis Foundation’s Therapeutic Development Network. He has authored or co-authored over 80 peer-reviewed publications, as well as multiple reviews. He trained in Pediatric Pulmonology and Pediatric Intensive Care at Hadassah Hospital in Jerusalem and subsequently at Boston Children`s Hospital, Harvard Medical School.
Panayot G. Filipov, M.D., is an Assistant Professor of Pediatrics and Neonatology at Maimonides Infants and Children’s Hospital. Dr. Panayot Filipov was awarded a medical degree from Medical Academy, Plovdiv, Bulgaria. He holds a Residency from Montefiore Medical Center/Albert Einstein College of Medicine and his fellowship is in Neonatal-Perinatal Medicine from Albert Einstein College of Medicine. He holds board-certifications in Neonatology and Pediatrics. His research interests include management of PDA, sepsis, nutrition, pulmonary hypertension, improvement of clinical practices.
Stacey Martiniano, M.D., is an Associate Professor of Pediatrics at the University of Colorado and Children’s Hospital Colorado and an Affiliate of National Jewish Health. She is a pediatric pulmonologist who focuses on lung infections, specifically, nontuberculous mycobacterial infections in children with cystic fibrosis. As a national clinical expert and lead researcher, Dr. Martiniano serves as national principal investigator of two multicenter studies in NTM: The Prospective Evaluation of NTM Disease in Cystic Fibrosis (PREDICT Study) and The Prospective Algorithm for Treatment of NTM in Cystic Fibrosis (PATIENCE Study). Both are funded by the Cystic Fibrosis Foundation. She is also the co-investigator and director of the Clinical Research Core for the Cystic Fibrosis Foundation Colorado’s CF NTM Research Development Program.
About Beyond Air, Inc.
Beyond Air, Inc. is a clinical-stage medical device and biopharmaceutical company developing a revolutionary NO Generator and Delivery System, LungFit™ that uses NO generated from ambient air to deliver precise amounts of NO to the lungs for the potential treatment of a variety of pulmonary diseases. The LungFit™ can generate up to 400 ppm of NO for delivery either continuously or for a fixed amount of time and has the ability to either titrate dose on demand or maintain a constant dose. The Company is currently applying its therapeutic expertise to develop treatments for pulmonary hypertension in various settings, in addition to treatments for lower respiratory tract infections that are not effectively addressed with current standards of care. Beyond Air is currently advancing its revolutionary LungFit™ in clinical trials for the treatment of bronchiolitis and severe lung infections such as nontuberculous mycobacteria (NTM). For more information, visit www.beyondair.net.
About Nitric Oxide (NO)
Nitric Oxide (NO) is a powerful molecule 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 and is used in adult respiratory distress syndrome and persistent pulmonary hypertension of the newborn. 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 organisms, including mycobacteria, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.
About the LungFit™ NO Generator and Delivery System*
Beyond Air’s NO Generator and Delivery System is a cylinder-free, phasic flow Nitric Oxide delivery system and has been designated as a medical device by the US 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™ 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 above 80 ppm for which intended treatments are: bronchiolitis in the hospital setting, and chronic, refractory lung infections in the home setting. For the first time, Beyond Air intends to offer NO treatment in the home setting with the elimination of cylinders.
* Beyond Air’s LungFit™ is not approved for commercial use and Beyond Air is not suggesting use over 80 ppm or use at home. Beyond Air’s LungFit™ is for investigational purposes only.
Persistent pulmonary hypertension of the newborn (PPHN) is a lethal condition and secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1000 live births (0.4-6.8/1000 live births) with mortality rate ranging between 4-33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality. NO gas is a vasodilator, is approved in dozens of countries to improve oxygenation and reduces the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents.
The majority of hospital admissions of infants with bronchiolitis are caused by respiratory syncytial virus (RSV). RSV is a common and highly transmissible virus that infects the respiratory tract of most children before their second birthday. While most infants with RSV present with minor respiratory symptoms, a small percentage develop serious lower airway infections, termed bronchiolitis, which can become life-threatening. The absence of treatment options for bronchiolitis limits the care of these sick infants to largely supportive measures. Beyond Air’s system is designed to effectively deliver over 80 ppm NO, for which preliminary studies indicate may eliminate bacteria, viruses, fungi and other microbes from the lungs.
Nontuberculous mycobacteria (NTM) is a rare and serious bacterial infection in the lungs causing debilitating pulmonary disease associated with increased morbidity and mortality. NTM infection is acquired by breathing in aerosolized bacteria from the environment, and if ignored can lead to NTM lung disease, a progressive and chronic condition. NTM is an emerging public health concern worldwide because of its multi-drug antibiotic resistance. Current treatment guidelines suggest a combination of multiple antibiotics delivered continually 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 for causing severe adverse events. Beyond Air’s system is designed to effectively deliver 150 – 400 ppm NO to the lung, and early data indicate that this range of NO concentration may have a positive effect on patients infected with NTM.
This press release contains “forward-looking statements.” 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,” “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 approach to discover and develop novel drugs, which is unproven and may never lead to marketable products; our ability to fund and the results of further pre-clinical and clinical trials; obtaining, maintaining and protecting intellectual property utilized by our products; 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; the successful development of our product candidates, all of which are in early stages of development; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; our dependence on collaborators; and our short operating history. 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.
Steven Lisi, Chief Executive Officer
Beyond Air, Inc.
LifeSci Advisors, LLC