Beyond Air® Reports Financial Results for Third Quarter of Fiscal Year 2024
Beyond Air, Inc. (NASDAQ: XAIR) reports solid revenue growth, increased demand for LungFit PH, FDA acceptance for label expansion, and positive clinical trial progress. The company reiterated revenue guidance for FY 2025 and announced key milestones for its various programs.
Positive
Solid sequential revenue growth of over 60% in Q3 FY 2024 compared to Q2.
Increasing demand for LungFit PH system with a 100% increase in filters shipped quarter over quarter.
FDA acceptance of PMA supplement for LungFit PH label expansion to include cardiac surgery.
U.S. pilot trial of LungFit PRO for viral community-acquired pneumonia underway.
Phase 1 study for UNO in solid tumors cleared first cohort with no toxicities.
Reiterated FY 2025 revenue guidance of $12-16 million.
Initiation of U.S. trials for NTM and COPD planned.
Positive first-in-human data for UNO therapy in solid tumors presented at SITC.
Plan to initiate a first-in-human study for ASD treatment in 2025.
Financial results show revenues of $0.4 million for Q3 2023.
Net loss attributed to common stockholders was ($16.2) million for Q3 2023.
Total cash burn in Q3 2023 was $12.7 million.
Company had cash, cash equivalents, marketable securities of $31.3 million as of December 31, 2023.
Negative
Increase in research and development expenses compared to the previous year.
General and administrative expenses increased due to stock-based compensation and salary inflation.
Net loss attributed to common stockholders increased compared to the same period in 2022.
Risks associated with ongoing clinical trials and FDA approvals.
Dependence on successful commercialization of products for revenue growth.
The acceptance of the PMA supplement for LungFit PH to include cardiac surgery by the FDA is a significant development, potentially expanding the device's market reach within the U.S. healthcare system. If approved, the expanded indication could lead to increased adoption in hospitals, thereby enhancing revenue streams. The reported sequential revenue growth of over 60% indicates strong commercial momentum, which is crucial for investor confidence, especially as Beyond Air aims to meet its FY 2025 revenue guidance of $12 to $16 million. However, it is worth noting that the company is still operating at a loss, with a reported net loss of ($16.2) million for the quarter. This underlines the importance of the upcoming milestones, such as the CE Mark expected in the first half of 2024, which could open up European markets and further drive sales growth.
The initiation of the U.S. pilot trial of LungFit PRO for VCAP and the ongoing Phase 1 study of ultra-high concentration nitric oxide (UNO) in solid tumors represent significant advancements in the company's clinical pipeline. The safety profile of UNO in the first cohort is promising, potentially indicating a new therapeutic avenue for patients with advanced solid tumors. The impact on the stock market hinges on the outcomes of these trials, as positive results could lead to increased investor interest and funding opportunities. Nevertheless, the long-term nature of clinical trials and the inherent risks associated with drug development should be considered, since any setbacks could adversely affect the company's valuation and financial stability.
The increasing demand for LungFit PH and the strategic focus on prioritizing certain clinical trials, such as those for viral community-acquired pneumonia and nontuberculous mycobacteria, suggest a targeted approach to capturing market share in specific segments of the respiratory treatment market. The anticipated software update and expansion into cardiac surgery applications could also serve to differentiate the product and increase its competitiveness. However, the market for medical devices and biopharmaceuticals is highly competitive and Beyond Air's ability to sustain growth and manage its cash burn rate will be critical. The raised capital of $5.5 million to partially offset cash burn reflects an active approach to financial management, but investors should monitor the balance between investment in growth and the path to profitability.
02/12/2024 - 04:05 PM
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 12 t h
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 t o $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 2024 PMA supplement for a cardiac surgery label expansion accepted for filing and under substantive review by the FDA Revenue 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 sites Top 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 FDA COPD 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 Study Preparations 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 2025 Published 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.
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About Beyond Air ® , Inc. ® 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 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 ® * 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 PPHN 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)
About NTM 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 Bronchiolitis
About Beyond Cancer, Ltd.
For more information, visit www.beyondcancer.com .
About UNO Therapy for Solid Tumors 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 ASD $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 Statements This 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 Corey Davis, Ph.D.Cdavis@lifesciadvisors.com
Media contacts Kori-Ann Taylorktaylor@beyondair.net
BEYOND AIR, INC. AND SUBSIDIARIES CONDENSED 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, $0.00 01 par value per share: 10,000,000 shares authorized, 0 shares issued and outstanding - - Common Stock, $0.00 01 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 SUBSIDIARIES CONDENSED 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
The revenue growth in Q3 FY 2024 was over 60% compared to Q2.
Beyond Air reiterated revenue guidance of $12-16 million for FY 2025.
FDA accepted the PMA supplement for LungFit PH label expansion to include cardiac surgery.
Sites opened for a U.S. pilot trial for patients hospitalized with viral community-acquired pneumonia.
The first cohort was cleared with no reported dose limiting toxicities.
Revenues for Q3 2023 were $0.4 million with a net loss of ($16.2) million.
