Beyond Air(XAIR)

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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]
Beyond Air(XAIR) - 2020 Q3 - Earnings Call Transcript
2020-02-10 18:05
Beyond Air, Inc. (NASDAQ:XAIR) Q3 2020 Results Conference Call February 7, 2020 11:00 AM ET Company Participants Monique Kosse - LifeSci Advisors Steve Lisi - Chairman and CEO Douglas Beck - Chief Financial Officer Amir Avniel - President and Chief Operating Officer Conference Call Participants Suraj Kalia - Oppenheimer Matt Kaplan - Ladenburg Thalmann Scott Henry - Roth Capital I-Eh Jen - Laidlaw Company Rahul Rakhit - LifeSci Capital James Molloy - Alliance Global Partners Operator Good morning, and welco ...
Beyond Air(XAIR) - 2020 Q3 - Quarterly Report
2020-02-07 22:01
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, 2019 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
2019-11-07 20:48
Transforming the lives of patients with respiratory conditions Transformational Therapies to Treat Serious Lung Infections & Pulmonary Hypertension Corporate Presentation November 2019 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 ...
Beyond Air(XAIR) - 2020 Q2 - Quarterly Report
2019-11-06 22:01
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, 2019 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 i ...
Beyond Air (XAIR) Investor Presentation - Slideshow
2019-09-27 16:54
Transforming the lives of patients with respiratory conditions Transformational Therapies to Treat Serious Lung Infections & Pulmonary Hypertension Corporate Presentation September 2019 Forward Looking Statement This presentation is for confidential and informational purposes only. This presentation 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 i ...
Beyond Air(XAIR) - 2020 Q1 - Quarterly Report
2019-08-14 20:46
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q 825 East Gate Boulevard, Suite 320 Garden City, NY 11530 (Address of principal executive offices) (Zip Code) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 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: 000-55759 B ...
Beyond Air(XAIR) - 2019 Q4 - Annual Report
2019-06-27 22:48
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, 2019 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 ...
AIT Therapeutics (AITB) To Present At Oppenheimer 29th Annual Healthcare Conference - Slideshow
2019-03-21 16:26
AIT Therapeutics Overview - AIT Therapeutics is a medical device company developing a Nitric Oxide generator system for various respiratory conditions[16, 194] - The company's proprietary technology generates NO from ambient air, eliminating the need for cylinders and potentially enabling home use[16, 124, 194] - AIT's Nitric Oxide Delivery System has demonstrated a safety record at a concentration of 160 ppm NO, with over 2,100 treatments in over 85 patients across 7 studies and no Serious Adverse Events (SAEs) related to NO therapy[16, 91, 92, 194] Target Indications and Market Potential - Pulmonary Hypertension (in-hospital): US sales potential >$300 million, worldwide sales potential >$600 million, with a planned launch in 2020[16, 155, 194] - Bronchiolitis (in-hospital): US sales potential >$500 million, worldwide sales potential >$12 billion, with a planned launch in 2021[16, 96, 155, 194] - Severe Lung Infections (at-home): US sales potential >$1 billion, worldwide sales potential >$25 billion, with a planned launch in 2023, initially targeting NTM abscessus (MABSC)[16, 126, 148, 155, 194] AirNOvent Platform and Partnership - AirNOvent is AIT's cylinder-free Nitric Oxide therapeutic platform for pulmonary hypertension treatment in the hospital setting[45, 52] - AIT has a partnership with Circassia Pharmaceuticals, with potential milestones of $3255 million and royalties of 15-20% on gross profit[78, 88] - AIT anticipates PMA filing with the FDA in the Second Quarter of 2019 and US commercial launch planned for the First Half of 2020[88] Financial Status - As of February 1, 2019, AIT had $13 million in cash and $0 in debt, with an expected monthly burn rate of $600,000-$650,000[176]
Beyond Air(XAIR) - 2019 Q3 - Quarterly Report
2019-02-14 21:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Commission file number: 000-55759 AIT Therapeutics, Inc. (Exact name of registrant as specified in its charter) 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, 2018 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________to _________ (State or other jurisdiction ...