Beyond Air® Reports Fiscal Third Quarter 2025 Financial Results And Provides Corporate Update
| Domestic: | 1-877-407-0784 | |
| International: | 1-201-689-8560 | |
| Conference ID: | 13750714 | |
| Webcast: | A webcast of the live conference call can be accessed by visiting the Events section of the Company's website (click here ) or directly (click here ). An online recording of the conference call will be available on the Company's website or via the direct link an hour after the call. |
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 .
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 in the United States of America, European Union, Australia and New Zealand. 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 4–33%. 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 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 .
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
...
(212) 915-2577
BEYOND AIR, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share and per share data)
| December 31, 2024 | March 31, 2024 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 4,601 | $ | 11,378 | ||||
| Marketable securities | 6,349 | 23,090 | ||||||
| Restricted cash | 232 | 230 | ||||||
| Accounts receivable, net | 639 | 319 | ||||||
| Inventory, net | 2,379 | 2,127 | ||||||
| Other current assets and prepaid expenses | 5,144 | 6,792 | ||||||
| Total current assets | 19,344 | 43,936 | ||||||
| Licensed right to use technology | 1,274 | 1,427 | ||||||
| Right-of-use lease assets | 1,775 | 2,121 | ||||||
| Property and equipment, net | 11,652 | 9,364 | ||||||
| Other assets | 100 | 113 | ||||||
| TOTAL ASSETS | $ | 34,144 | $ | 56,961 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,357 | $ | 1,948 | ||||
| Accrued expenses and other current liabilities | 2,631 | 8,402 | ||||||
| Operating lease liability, current portion | 381 | 418 | ||||||
| Loans payable, current portion | 60 | 800 | ||||||
| Total current liabilities | 5,430 | 11,567 | ||||||
| Operating lease liability, net | 1,567 | 1,898 | ||||||
| Long-term debt, net | - | 14,721 | ||||||
| Long-term liability, related party | 8,710 | - | ||||||
| Warrant liability | 56 | 275 | ||||||
| Derivative liability | - | 1,314 | ||||||
| Total liabilities | 15,763 | 29,775 | ||||||
| Stockholders' equity | ||||||||
| Preferred Stock, $0.0001 par value per share: 10,000,000 shares authorized, 0 shares issued and outstanding | - | - | ||||||
| Common Stock, $0.0001 par value per share: 500,000,000 shares authorized, 74,328,645 and 45,900,821 shares issued and outstanding as of December 31, 2024 and March 31, 2024, respectively | 7 | 5 | ||||||
| Treasury stock | (25 | ) | (25 | ) | ||||
| Additional paid-in capital | 296,000 | 264,780 | ||||||
| Accumulated deficit | (278,288 | ) | (239,697 | ) | ||||
| Accumulated other comprehensive income (loss) | (51 | ) | (15 | ) | ||||
| Total stockholders' equity attributable to Beyond Air, Inc | 17,644 | 25,048 | ||||||
| Non-controlling interest | 738 | 2,138 | ||||||
| Total equity | 18,381 | 27,186 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 34,144 | $ | 56,961 | ||||
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, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues | $ | 1,072 | $ | 391 | $ | 2,553 | $ | 689 | ||||||||
| Cost of revenues | 1,287 | 748 | 4,184 | 1,483 | ||||||||||||
| Gross loss | (215 | ) | (356 | ) | (1,631 | ) | (794 | ) | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | (3,005 | ) | (6,838 | ) | (13,599 | ) | (18,664 | ) | ||||||||
| Selling, general and administrative | (7,732 | ) | (9,768 | ) | (22,133 | ) | (30,915 | ) | ||||||||
| Total Operating expenses | (10,737 | ) | (16,606 | ) | (35,732 | ) | (49,578 | ) | ||||||||
| Loss from Operations | (10,952 | ) | (16,963 | ) | (37,363 | ) | (50,372 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Dividend/investment income | 126 | 388 | 637 | 1,438 | ||||||||||||
| Interest and finance expense | (549 | ) | (919 | ) | (2,439 | ) | (1,991 | ) | ||||||||
| Change in fair value of warrant liability | 4 | 46 | 219 | 693 | ||||||||||||
| Change in fair value of derivative liability | - | 135 | 1,314 | 1,147 | ||||||||||||
| Foreign exchange gain/ (loss) | 46 | 31 | (26 | ) | (3 | ) | ||||||||||
| Loss on extinguishment of debt | (1,910 | ) | - | (2,534 | ) | - | ||||||||||
| Loss on disposal of fixed assets | (62 | ) | - | (233 | ) | - | ||||||||||
| Estimated liability for contingent loss | - | (11 | ) | - | (609 | ) | ||||||||||
| Other income / (expense) | (37 | ) | 35 | 11 | (42 | ) | ||||||||||
| Total other income/ (expense) | (2,381 | ) | (294 | ) | (3,052 | ) | 633 | |||||||||
| Net loss before income taxes | $ | (13,333 | ) | $ | (17,258 | ) | $ | (40,416 | ) | $ | (49,739 | ) | ||||
| Provision for income taxes | - | - | - | - | ||||||||||||
| Net loss | $ | (13,333 | ) | $ | (17,258 | ) | $ | (40,416 | ) | $ | (49,739 | ) | ||||
| Less : net loss attributable to non-controlling interest | (300 | ) | (1,038 | ) | (1,825 | ) | (3,204 | ) | ||||||||
| Net loss attributable to Beyond Air, Inc. | (13,032 | ) | (16,220 | ) | (38,591 | ) | (46,535 | ) | ||||||||
| Foreign currency translation loss | (61 | ) | (9 | ) | (37 | ) | (19 | ) | ||||||||
| Comprehensive loss attributable to Beyond Air, Inc. | $ | (13,093 | ) | $ | (16,229 | ) | $ | (38,628 | ) | $ | (46,554 | ) | ||||
| Net basic and diluted loss per share attributable to Beyond Air, Inc. | $ | (0.15 | ) | $ | (0.50 | ) | $ | (0.64 | ) | $ | (1.46 | ) | ||||
| Weighted average number of shares, outstanding, basic and diluted | 88,074,511 | 32,462,476 | 60,417,218 | 31,883,799 |
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