Appointed industry veteran,
Recently upgraded LungFit PH device expands customer base; revenue growth expected to accelerate
each quarter going forward
FY 2025 revenue guidance revised to greater than
Implemented capital conservation strategy to reduce cash burn
Conference call scheduled for
“I am proud of the
“Over the past few months, we implemented a strategy to conserve capital as we continue building momentum around the commercial launch of LungFit PH. This will significantly reduce our quarterly spend going forward. The impacted R&D projects include our VCAP program, which was placed on hold, and our LungFit GO home-based device for NTM and other lung infections, which we are now bringing in-house for design and development, resulting in a modest delay. We continue to target initiation of the next clinical study for the NTM program during calendar year 2026. Separately, our cancer and autism programs are anticipated to be self-funded. Given these adjustments, we expect our operations to be funded through at least July 2025,” stated
Recent Highlights and Upcoming Milestones
- LungFit® PH
- Commercial demand continues to increase for LungFit PH, as evidenced by:
- To date, LungFit PH devices have been used in more than 50 hospitals
- To date, over 1,100 patients have been treated with LungFit PH, accounting for more than 75,000 hours of treatment
- Current customers extend across 10 states in the
U.S.
- Appointed
David Webster as new Chief Commercial Officer to lead commercial operations - FDA decision expected in the fourth quarter of CY 2024 for the pending PMA supplement for cardiac surgery
- Awaiting updates on timing for CE Mark for LungFit PH in
Europe - Updated revenue guidance to greater than
$10 million for FY 2025, from the previous guidance of$12 million to$16 million
- Commercial demand continues to increase for LungFit PH, as evidenced by:
- Beyond Cancer - Solid Tumor Program
- Ultra high concentration Nitric Oxide (UNO) therapy is in an ongoing Phase 1a trial evaluating advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors
- The ongoing Phase 1a trial reported encouraging first-in-class clinical data demonstrating evidence of immune system activation via biomarker response in a heavily pretreated population. These data were presented at the American Society of Clinical Oncology Key Opinion Leader Event held in conjunction with the 2024 Annual Meeting
- Upon regulatory approval, a Phase 1b trial will enroll up to 20 subjects with prior exposure to anti-PD-1 antibody that have either progressed, not achieved a response, or have prolonged stable disease (≥ 12 weeks) on single agent anti-PD-1 without radiographic evidence of continued tumor reduction. Subjects enrolled in the Phase 1b trial will be treated with UNO + anti-PD-1 combination upon completion of the Phase 1a trial prior to the end of this year
- Ultra high concentration Nitric Oxide (UNO) therapy is in an ongoing Phase 1a trial evaluating advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors
- Capital Conservation Strategy
- The Company implemented a capital conservation strategy that will extend its cash runway and focus its resources on ramping up the commercial program for LungFit PH and maintain the timeline for the second generation LungFit PH
- Reduced headcount by over 20% since
January 1, 2024 - Study of LungFit® PRO to treat viral community-acquired pneumonia (VCAP) has been placed on hold due to strategic prioritization
- The trials evaluating LungFit® GO for the treatment of nontuberculous mycobacteria (NTM) and COPD have been placed on hold due to strategic prioritization; and the design and development of the LungFit GO device will be performed in-house and LungFit GO will be ready for clinical studies in calendar year 2026
- Beyond Cancer subsidiary – planned Phase 1b clinical trial of UNO in combination with anti-PD1 will begin enrollment by the end of calendar 2024
- NeuroNOS subsidiary – plan to initiate first-in-human autism spectrum disorder (ASD) study in 2025, pending available funding
- Reduced headcount by over 20% since
- Net cash burn rate is expected to be less than
$30 million in FY 2025, which assumes the Company hits certain revenue targets. The quarter endedJune 30, 2024 will include initial costs associated with implementing the capital preservation strategy. Net cash burn is expected to continue to decline in FY 2026 with an expectation that the Company will achieve cash flow breakeven in the fourth fiscal quarter of 2026.
- The Company implemented a capital conservation strategy that will extend its cash runway and focus its resources on ramping up the commercial program for LungFit PH and maintain the timeline for the second generation LungFit PH
Financial Results for the Fiscal Year Ended
Revenues for the fiscal year ended
Research and development expenses for the fiscal year ended
General and administrative expenses for the fiscal years ended
Net loss attributed to common stockholders for the fiscal year ended
Adjusted cash burn in the fiscal year ended
Over the course of the fiscal year, the Company received net proceeds of
As of
Conference Call & Webcast | |
Domestic: | 1-877-407-0784 |
International: | 1-201-689-8560 |
Conference ID: | 13746892 |
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 replay will be available on the Company’s website or via the direct link an hour after the call. |
About
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
* Beyond Air’s LungFit PH is approved for commercial use only in
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 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
About
Beyond
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 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
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
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-
CONDENSED CONSOLIDATED BALANCE SHEETS (amounts in thousands, except share and per share data) | |||||||
ASSETS | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 11,378 | $ | 29,158 | |||
Marketable securities | 23,090 | 16,724 | |||||
Restricted cash | 230 | 7,610 | |||||
Accounts receivable | 319 | - | |||||
Grant receivable | - | 420 | |||||
Inventory | 2,127 | 1,129 | |||||
Other current assets and prepaid expenses | 6,792 | 4,369 | |||||
Total current assets | 43,936 | 59,410 | |||||
Licensed right to use technology | 1,427 | 1,632 | |||||
Right-of-use lease assets | 2,121 | 2,493 | |||||
Property and equipment, net | 9,364 | 5,003 | |||||
Other assets | 113 | 212 | |||||
TOTAL ASSETS | $ | 56,961 | $ | 68,749 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities | |||||||
Accounts payable | $ | 1,948 | $ | 2,016 | |||
Accrued expenses and other current liabilities | 8,402 | 16,613 | |||||
Operating lease liability, current portion | 418 | 376 | |||||
Loans payable, current portion | 800 | 775 | |||||
Total current liabilities | 11,567 | 19,780 | |||||
Operating lease liability, net | 1,898 | 2,321 | |||||
Long-term debt, net | 14,721 | 120 | |||||
Warrant liability | 275 | - | |||||
Derivative liability | 1,314 | - | |||||
Other long-term liabilities | - | 4,500 | |||||
Total liabilities | 29,775 | 26,721 | |||||
Stockholders’ equity | |||||||
Preferred Stock, authorized, 0 shares issued and outstanding | - | - | |||||
Common Stock, authorized, 45,900,821 and 30,738,585 shares issued and outstanding as of | 5 | 3 | |||||
(25 | ) | (25 | ) | ||||
Additional paid-in capital | 264,780 | 217,339 | |||||
Accumulated deficit | (239,697 | ) | (179,455 | ) | |||
Accumulated other comprehensive income /(loss) | (15 | ) | 53 | ||||
Total stockholders’ equity attributable to | 25,048 | 37,915 | |||||
Non-Controlling Interest | 2,138 | 4,113 | |||||
Total equity | 27,186 | 42,028 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 56,961 | $ | 68,749 | |||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (amounts in thousands, except share and per share data) | |||||||
Year Ended | Year Ended | ||||||
Revenue | $ | 1,159 | $ | - | |||
Cost of revenue | (2,466 | ) | (555 | ) | |||
Gross loss | (1,307 | ) | (555 | ) | |||
Operating expenses | |||||||
Research and development | (24,363 | ) | (16,810 | ) | |||
General and administrative | (37,337 | ) | (34,694 | ) | |||
Total operating expenses | (61,700 | ) | (51,504 | ) | |||
Loss from operations | $ | (63,006 | ) | $ | (52,059 | ) | |
Other income (expense) | |||||||
Dividend and interest income | 1,739 | 656 | |||||
Change in fair value of warrant liability | 611 | - | |||||
Change in fair value of derivative liability | 48 | - | |||||
Estimated contingent loss | (598 | ) | (7,863 | ) | |||
Other expense | (169 | ) | - | ||||
Interest and finance expense | (2,912 | ) | (30 | ) | |||
Foreign exchange loss | (6 | ) | (105 | ) | |||
Total other income /(expense) | (1,288 | ) | (7,342 | ) | |||
Net loss before income taxes | (64,295 | ) | (59,401 | ) | |||
Provision for income taxes | - | - | |||||
Net loss | $ | (64,295 | ) | $ | (59,401 | ) | |
Less: net loss attributable to non-controlling interest | (4,053 | ) | (3,585 | ) | |||
Net loss attributable to | $ | (60,242 | ) | $ | (55,816 | ) | |
Other comprehensive loss, net of tax: | |||||||
Foreign currency translation gain (loss) | (68 | ) | (43 | ) | |||
Comprehensive loss attributable to | $ | (60,310 | ) | $ | (55,859 | ) | |
Net basic and diluted loss per share attributable to | $ | (1.82 | ) | $ | (1.86 | ) | |
Weighted average number of shares of common stock outstanding – basic and diluted | 33,160,180 | 29,973,639 |
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CONTACTS: Investor Relations contactsCorey Davis , Ph.D.LifeSci Advisors, LLC Cdavis@lifesciadvisors.com (212) 915-2577
2024 GlobeNewswire, Inc., source