On February 9, 2023 Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company") a commercial 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, and, through its affiliate Beyond Cancer, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported financial results for its third fiscal quarter ended December 31, 2022 (Press release, Beyond Air, FEB 9, 2023, View Source [SID1234627012]).
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"We are successfully executing on our planned limited launch of LungFit PH in the United States. Demand among targeted hospitals for demonstrations and evaluations continues to grow, and we look forward to recording our first sales during the March quarter," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air.
"Over the past few years, we have presented data which have demonstrated the safety of inhaled nitric oxide at high concentrations, administered intermittently, in more than 12 clinical settings with over 170 patients treated and more than 5,000 treatments administered with no serious adverse reactions related to nitric oxide. Strong efficacy signals were also demonstrated, especially in viral respiratory infections. We believe high concentration NO delivery with our LungFit PRO generator and delivery system can be a powerful tool against any type of pneumonia, regardless of the type of virus, including SARS-CoV2, and our company is dedicated to bringing this important therapy to market as soon as possible."
"Throughout the year, the team at Beyond Cancer has made incredible progress," continued Mr. Lisi. "The pre-clinical results presented during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2022 annual meeting in November offer an encouraging first look at the potential synergistic effect of UNO therapy when combined with anti-PD-1 therapy. We are pleased to have also published our early pre-clinical work in the peer-reviewed journal Cancer Cell International ("CCI") in December. These impressive data support our understanding of UNO as an immunomodulating therapeutic option for the treatment of solid tumors and prevention of metastases and we look forward to further elucidating the powerful effects of UNO in human trials."
Recent Highlights and Upcoming Milestones
LungFit PH
Ongoing progress with limited release phase of commercial launch, making it the first and only nitric oxide generator, delivery, and monitoring system available in the United States
CE Mark anticipated to be received in the first half of fiscal year 2024, which is expected to be followed by an international commercial partnership
Expect to submit a PMA supplement for a cardiac label expansion for LungFit PH to the FDA in the first half of calendar year 2023
LungFit PRO
ID Week 2022 – the Company presented positive data showing a strong safety profile and statistically significant results on key endpoints in patients hospitalized with viral respiratory infections, including SARS-CoV2
Plan to initiate a U.S. trial for patients hospitalized with viral community-acquired pneumonia (VCAP), including COVID-19, in the fourth quarter of calendar year 2023, pending discussion with the FDA
LungFit GO
American College of Chest Physicians (CHEST) Annual Meeting 2022 – the Company presented positive safety, tolerability, and efficacy data from the LungFit GO pilot at-home study of patients with severe, treatment refractory, NTM lung disease
Plan to initiate a U.S. trial for patients with NTM in the second half of fiscal year 2025, pending discussion with the FDA
Plan to initiate a U.S. pilot trial in COPD patients who are hospitalized due to a exacerbation in the fourth quarter of calendar 2024, pending discussion with FDA
Beyond Cancer’s Solid Tumor Program
Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2022 – presented promising new data in mice for UNO therapy, which showed a doubling of survival when UNO was combined with anti-PD1 compared with anti-PD1 alone
Published pre-clinical data in Cancer Cell International (CCI) on December 13, 2022, which demonstrated that the company’s tumor ablation method results in a potent systemic immune response to the specific tumor type treated. Treated mice were immune to a re-introduction or tumor challenge resulting in a significant improvement in survival for UNO treated mice compared to control mice
Received a notice of allowance for its patent titled, "System and Method for Delivery or Gas to a Tissue", which is the first patent covering Beyond Cancer’s UNO therapy
Announced a sponsored research agreement with Stanford University, and the expansion of Beyond Cancer’s Scientific Advisory Board (SAB)
Financial Results for the Fiscal Quarter Ended December 31, 2022
Research and development expenses for the fiscal quarter ended December 31, 2022 were $5.0 million, compared with $2.5 million for the fiscal quarter ended December 31, 2021. The increase was driven mainly by compensation costs from scaling up operations in Beyond Cancer as well as from increased investments in pre-clinical work being done across the Group in our targeted therapeutic areas.
General and administrative expenses for the fiscal quarter ended December 31, 2022 increased to $8.9 million, compared with $4.9 million for the fiscal quarter ended December 31, 2021. The increase includes $3.0 million of planned structural investments in Beyond Cancer and $1.0 million attributable to continued investments in people and systems necessary to support the commercial launch of LungFit PH in the U.S.
Other income and expense was a $0.2 million gain for the fiscal quarter ended December 31, 2022, compared with a $0.5 million loss for the fiscal quarter ended December 31, 2021. The two main drivers in this year-over-year improvement were gains made from the Company’s investment in marketable securities as well as favorable foreign exchange movements.
For the fiscal quarter ended December 31, 2022, the Company had a GAAP net loss of $13.8 million, of which $12.7 million, or ($0.43) per share, was attributable to the shareholders of Beyond Air, Inc., compared with a net loss of $7.7 million, or ($0.29) per share, for the fiscal quarter ended December 31, 2021.
As of December 31, 2022, the Company reported cash and cash equivalents, marketable securities, and restricted cash of $63.2 million.
Total cash burn in the quarter ended December 31, 2022, was $9.3 million, which is in line with the Company’s quarterly cash burn guidance of $8.0 – 10.0 million per quarter. Through the first nine months of the Company’s fiscal year 2023, total cash burn was $27.0 million which includes $2.5 million in non-recurring expense.