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Beyond Air (XAIR) Investor Presentation - Slideshow
2021-02-10 09:39
Corporate Presentation 1 February 2021 Forward Looking Statement This presentation is for informational purposes only and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities of Beyond Air, Inc. (the "Company") nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. The C ...
Beyond Air(XAIR) - 2021 Q3 - Earnings Call Transcript
2021-02-10 01:26
Beyond Air, Inc. (NASDAQ:XAIR) Q3 2021 Earnings Conference Call February 9, 2021 4:30 PM ET Company Participants Maria Yonkoski – Head-Investor Relations Steve Lisi – Chairman and Chief Executive Officer Douglas Beck – Chief Financial Officer Duncan Fatkin – Chief Commercial Officer Conference Call Participants Suraj Kalia – Oppenheimer & Company Scott Henry – ROTH Capital Matt Kaplan – Ladenburg Yale Jen – Laidlaw & Co. Gregg Gilbert – Truist Operator Greetings, and welcome to Beyond Air Incorporated Third ...
Beyond Air(XAIR) - 2021 Q3 - Quarterly Report
2021-02-09 22:29
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2020 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________to _________ Commission File Number: 001-38892 BEYOND AIR, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of in ...
Beyond Air (XAIR) Investor Presentation - Slideshow
2020-11-22 19:30
Company Overview - Beyond Air's LungFit™ devices generate nitric oxide (NO) from ambient air, offering on-site generation compared to fixed cylinder systems[8] - The company is developing NO therapies for various lung infections, including acute viral pneumonia, bronchiolitis, and nontuberculous mycobacteria (NTM)[8] - Beyond Air is also in preclinical development of ultra-high concentration (10,000+ ppm) NO for solid tumors[8] - The company anticipates a US launch of LungFit™ PH in 2Q21 for in-hospital use for PPHN and cardiac surgery, with CE Mark expected in 2H21[11] Market Potential - The US sales potential for in-hospital use for PPHN and cardiac surgery is estimated to be >$300 million, with a worldwide sales potential of >$600 million[16] - The US sales potential for acute viral pneumonia (including COVID-19) is estimated to be >$1.5 billion, with a worldwide sales potential of >$3 billion (excluding pandemic)[16] - The US sales potential for bronchiolitis is estimated to be >$500 million, with a worldwide sales potential of >$1.2 billion[16] - The US sales potential for nontuberculous mycobacteria (NTM) lung infection is estimated to be >$1 billion, with a worldwide sales potential of >$2.5 billion[17] - The potential market for severe exacerbations due to lung infections in COPD patients is estimated to be >$2.5 billion in the US and >$6 billion worldwide[19] Clinical Data and Safety - Pilot studies with high concentration NO (up to 250 ppm) have shown no serious adverse events (SAEs) in humans[52] - A 2019-2020 pilot study in bronchiolitis (n=89) showed statistically significant improvements with 150 ppm treatment compared to 85 ppm and control[51] - In a pilot study with NTM infected CF patients, bacterial load was reduced by 65% at day 81 versus baseline with 160 ppm NO[96] Financial Information - As of September 30, 2020, Beyond Air had $22.4 million in cash and cash equivalents and $5 million in debt[109] - The expected quarterly burn rate is approximately $4-5 million[109]
Beyond Air(XAIR) - 2021 Q2 - Quarterly Report
2020-11-12 13:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________to _________ Commission File Number: 001-38892 BEYOND AIR, INC. (Exact name of registrant as specified in its charter) Delaware 47-3812456 (State or oth ...
Beyond Air(XAIR) - 2021 Q2 - Earnings Call Transcript
2020-11-12 03:30
Beyond Air, Inc. (NASDAQ:XAIR) Q2 2021 Results Conference Call November 11, 2020 4:30 PM ET Company Participants Maria Yonkoski - Head, Investor Relations Steve Lisi - Chairman and Chief Executive Officer Doug Beck - Chief Financial Officer Conference Call Participants Suraj Kalia - Oppenheimer & Company Matt Kaplan - Ladenburg Thalmann Scott Henry - ROTH Capital Yale Jen - Laidlaw & Company Operator Greetings, and welcome to Beyond Air, Inc. Second Quarter 2021 Earnings and Corporate Update Call. At this t ...
Beyond Air(XAIR) - 2021 Q1 - Earnings Call Transcript
2020-08-08 02:36
Financial Data and Key Metrics Changes - Revenue for Q1 2021 was $229,000, down from $627,000 in Q1 2020, primarily due to the termination of a commercial agreement for LungFit PH [33] - Research and development expenses increased to $4.3 million from $2.3 million year-over-year, while general and administrative expenses rose to $2.5 million from $2.2 million [34] - The net loss for the quarter was $6.7 million, or $0.40 per share, compared to a net loss of $6.2 million, or $0.67 per share, in the same period last year [35] Business Line Data and Key Metrics Changes - The LungFit PH program remains the lead initiative, focusing on treating persistent pulmonary hypertension of newborns and certain cardiac surgery patients [11] - The COVID-19 program has shown an excellent safety profile in ongoing studies, with expectations to conclude within 60 days [18] - The bronchiolitis program has produced positive efficacy and safety data, although it is currently on hold due to the pandemic [22] Market Data and Key Metrics Changes - The U.S. market for nitric oxide delivery systems is estimated to exceed $300 million, with a global market potential of over $600 million [17] - The company anticipates a U.S. commercial launch of the LungFit PH system in Q2 2021, pending FDA approval [13] Company Strategy and Development Direction - The company aims to disrupt the current nitric oxide supply chain to hospitals by eliminating the need for cylinder-based systems [10] - A commercial supply agreement has been signed with Spartronics for the LungFit systems, marking a critical step in preparation for PMA submission [37] - The company is preparing for a controlled, step-wise launch of the LungFit PH system, focusing on a small percentage of hospitals initially [65] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting the PMA submission timeline despite potential COVID-related delays [39] - The company is closely monitoring the regulatory environment and market conditions, particularly in Europe, for potential partnerships [50] - Management highlighted the importance of demonstrating safety in home settings for long-term use of the LungFit system [42] Other Important Information - The company has sufficient cash reserves of $24.4 million to fund operations well beyond 12 months [35] - The LungFit Home program is set to initiate a pilot study for nontuberculous mycobacteria lung infection, with enrollment expected to begin in Q4 2020 [25] Q&A Session Summary Question: What remains to be done for the PMA submission? - Management indicated that extensive testing and documentation are required over the next eight weeks to facilitate the PMA submission [39] Question: What safety measures are in place for home use of the system? - Management emphasized the importance of NO2 safety and described various fail-safes and alarms integrated into the system to ensure safety during operation [42][44] Question: What is the status of the Canadian trial for COVID-19? - Management confirmed that the Canadian trial has not yet started and is evaluating whether it is worthwhile to proceed given the current situation [81][86] Question: When can we expect data from the Canadian trial? - Management stated that data from the Canadian trial would be available after the U.S. trial, which is expected to conclude first [52] Question: What are the plans for the solid tumor program? - Management indicated that additional preclinical data would be presented later this year, with a path to first-in-man studies anticipated in 12 to 15 months [76]
Beyond Air(XAIR) - 2021 Q1 - Quarterly Report
2020-08-06 21:27
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________to _________ 516-665-8200 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: | Title of each cl ...
Beyond Air(XAIR) - 2020 Q4 - Annual Report
2020-06-23 21:21
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED MARCH 31, 2020 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-38892 BEYOND AIR, INC. (Exact name of registrant as specified in its charter) Delaware 47-3812456 (State or Other Jurisdiction of Incorporation or Organization) 825 Ea ...
Beyond Air(XAIR) - 2020 Q4 - Earnings Call Transcript
2020-06-23 02:28
Financial Data and Key Metrics Changes - Revenue for the fiscal year ended March 31, 2020, was $1.4 million, a decrease from $7.7 million in fiscal 2019 [40] - Research and development expenses increased to $10.6 million from $3.9 million in fiscal 2019 [41] - General and administrative expenses rose to $8.9 million compared to $6.9 million in fiscal 2019 [41] - The net loss to common shareholders was $20.5 million or $1.78 per share, compared to a net loss of $6.6 million or $0.77 per share in fiscal 2019 [41] - As of March 31, 2020, the company had cash, cash equivalents, and restricted cash of $25.5 million, sufficient to fund operations beyond the next 12 months [42] Business Line Data and Key Metrics Changes - The company is focused on its LungFit system, which is designed to generate nitric oxide from ambient air and deliver it to patients, differentiating it from traditional cylinder-based systems [12][13] - The LungFit PH system is being developed for persistent pulmonary hypertension of the newborn and is a key focus area for the company [27] - The LungFit HOME program aims to allow patients to self-administer nitric oxide therapy, with a pilot study planned for 20 patients by the end of 2020 [30][31] Market Data and Key Metrics Changes - The market for the LungFit PH system is estimated to be over $300 million in the U.S. and more than $600 million worldwide [29] - The company anticipates significant opportunities in treating hospitalized patients diagnosed with COVID-19 using the LungFit system [18] Company Strategy and Development Direction - The company aims to obtain FDA clearance for the LungFit system in the first half of 2021, which is expected to position it favorably against traditional delivery systems [12][28] - The company is preparing for a pivotal trial for bronchiolitis treatment, with plans to initiate this study in the fourth quarter of 2021 at the earliest [26] - The company is also exploring the potential of high-concentration nitric oxide in treating various solid tumors, with promising preclinical data [34][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the LungFit system and its ability to address unmet medical needs, particularly in the context of COVID-19 [47][49] - The ongoing COVID-19 pandemic has impacted timelines for clinical programs, but the team is working diligently to resume normal activities [49] - Management highlighted the importance of safety and efficacy in developing therapies during the pandemic, emphasizing the need for rapid deployment of treatments [16] Other Important Information - The company entered into a $25 million line of credit available for three years, with the first tranche of $5 million already drawn [43] - A new common stock purchase agreement for up to $40 million was established, extending until May 2023 [44] Q&A Session Summary Question: Number of patients treated under the U.S. COVID study and the Canadian study - The U.S. study will enroll 20 patients, and stage one of the Canadian study will involve 10 patients [53] Question: Timing for the U.S. study - Exact timing for completion is uncertain due to the current environment and competition for patients [56] Question: PPHN PMA submission timeline - The submission is targeted for the end of September, pending completion of logistical challenges [58][59] Question: Safety concerns regarding higher doses of nitric oxide - The FDA has requested starting with 80 parts per million for safety reasons, but the company has not observed safety issues at higher concentrations in previous studies [74][75] Question: Insights from the third bronchiolitis pilot study - The study confirmed that higher concentrations of nitric oxide are necessary for efficacy, and adjustments were made to improve the treatment process [71][72] Question: Future steps if U.S. and Canadian data are positive - If data is favorable, the next step would likely be a pivotal trial, but this will depend on discussions with regulatory agencies [83]