Beyond Air® Reports Financial Results for Third Quarter of Fiscal Year 2024
- 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.
- 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.
Insights
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.
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
Conference call scheduled for 4:30 p.m. ET today, February 12th
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
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
- Commercial demand continues to increase for the LungFit PH, as evidenced by a more than
- 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
- Sites opened for a U.S. pilot trial for patients hospitalized with viral community-acquired pneumonia (VCAP)
- 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)
- 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
- 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
Research and development expenses for the three months ended December 31, 2023 were
General and administrative expenses for the three months ended December 31, 2023 and December 31, 2022 were
Net loss attributed to common stockholders for the three months ended December 31, 2023, was (
Total cash burn in the quarter ended December 31, 2023, was
As of December 31, 2023, the Company had cash, cash equivalents, marketable securities of
Conference Call & Webcast
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About Beyond Air®, Inc.
Beyond Air is a commercial stage medical device and biopharmaceutical company dedicated to 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. The Company has received FDA approval for its first system, LungFit® 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
Nitric Oxide is a powerful molecule, naturally synthesized in the human body, 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. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. 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 pathogens, including mycobacteria, viruses, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.
About LungFit®*
Beyond Air’s LungFit is a cylinder-free, phasic flow generator and delivery system and has been designated as a medical device by the U.S. 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 ppm to 80 ppm. The LungFit system 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. LungFit can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting (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
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–
About Viral Community-Acquired Pneumonia (VCAP)
In adults, viruses have been identified as the causative agents in approximately 100 million cases of community-acquired pneumonia per year. While viral pneumonia in adults is most commonly caused by rhinovirus, respiratory syncytial virus (RSV) and influenza virus, newly emerging viruses (including SARS-CoV-1, SARS-CoV-2, avian influenza A, and H1N1 viruses) have been identified as pathogens contributing to the overall burden of adult viral pneumonia. Patients aged 65 years or older are at particular risk for death from the disease, as are patients with other underlying health conditions or weakened immune systems. There is no consensus regarding the use of antiviral drugs to treat viral pneumonia, and specific preventative measures are currently limited to the influenza vaccine. Given that current treatment recommendations are largely limited to supportive care, there is an unmet medical need for effective treatment options. NO may prove to be a treatment as the impact on the lung should result in bronchodilation, reduction in inflammation and inhibition of the viral replication process.
About NTM
NTM infection is a rare and serious bacterial infection in the lungs causing debilitating pulmonary disease associated with high morbidity and mortality. NTM infection is acquired by inhaling aerosolized bacteria from the environment, and can lead to NTM lung disease, a progressive and chronic condition. According to the Cystic Fibrosis Foundation,
About Bronchiolitis
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 150 – 400 ppm NO, for which preliminary studies indicate may eliminate bacteria, viruses, fungi, and other microbes from the lungs.
About Beyond Cancer, Ltd.
Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc., is a development-stage biopharmaceutical and medical device company utilizing (UNO via a proprietary delivery platform to treat primary tumors and prevent metastatic disease. Nitric oxide at ultra-high concentrations has been reported to show anticancer properties and to potentially serve as a chemosensitizer and radiotherapy enhancer. A first-in-human study is underway in patients with solid tumors. The Company is conducting preclinical studies of UNO in multiple solid tumor models to inform additional treatment protocols.
For more information, visit www.beyondcancer.com.
About UNO Therapy for Solid Tumors
Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately
About ASD
ASD is a serious neurodevelopmental and behavioral disorder, and one of the most disabling conditions and chronic illnesses in children. ASDs include a wide range of developmental disorders that share a core of neurobehavioral deficits manifested by abnormalities in social interactions, deficits in communication, restricted interests, and repetitive behaviors. In 2023, the CDC reported that approximately 1 in 36 children in the U.S. is diagnosed with an ASD. On average, ASD costs an estimated
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.
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577
Media contacts
Kori-Ann Taylor
Head of Marketing
ktaylor@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, | - | - | ||||||
| Common Stock, | 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 | ||||||||||||
FAQ
What was the revenue growth percentage in Q3 FY 2024 compared to Q2?
What is the expected revenue guidance for FY 2025?
What key milestone was achieved for LungFit PH label expansion?
What progress was reported for the U.S. pilot trial of LungFit PRO?
What was the outcome of the Phase 1 study for UNO in solid tumors?
What financial results were reported for Q3 2023?
