Provides fiscal year 2025 revenue guidance of
US pilot trial of LungFit® PRO to treat viral community acquired pneumonia (VCAP) underway with data expected mid-calendar 2024
Beyond Cancer presents positive first-in-human data for intratumoral administration of ultra-high concentration nitric oxide (UNO) therapy demonstrating safety and evidence of immune system activation at the
Submitted PMA supplement to FDA for the expansion of LungFit PH label to include cardiac surgery; approval anticipated in second half calendar 2024
LungFit PH granted Innovative Technology contract from
Entered into an agreement with
Conference call scheduled for
“The Beyond Air and Beyond Cancer teams continue to execute. In the last three months, we have made significant strides in the US hospital market with LungFit PH, licensed LungFit PH in certain Asian markets, submitted a PMA supplement to the FDA for cardiac surgery, presented preclinical and human data for treatment of solid tumors with UNO and began the United States VCAP study,” said
Recent Highlights and Upcoming Milestones
- LungFit® PH
- Provided revenue guidance of
$12 -$16 million for the fiscal year endingMarch 31, 2025 - Entered into an agreement with
Getz Healthcare to commercialize the LungFit PH device in certain countries across theAsia-Pacific region , paving the way for an ex-U.S. launch - Received an Innovative Technology contract from
Vizient Inc. based on recommendations by hospital experts who serve on Vizient’s customer-led councils - CE Mark anticipated to be received in first half calendar 2024
- Submitted a PMA supplement to the FDA for a cardiac surgery label expansion; approval anticipated in calendar year 2024
- Provided revenue guidance of
- LungFit® PRO
- Initiated the process for opening sites 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 10 sites
- Top line data expected mid-year 2024 from VCAP study
- Initiated the process for opening sites for a
- 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
- Plan to initiate a
- Beyond Cancer - Solid Tumor Program
- First-in-human data presented at the
Society for Immunotherapy Conference (SITC) inNovember 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) - Published pre-clinical data demonstrating that UNO therapy combined with anti-mPD-1 has a synergistic immune response resulting in a significant improvement in tumor regression rates and survival in mice
- Pooled data analysis of combination studies with 50,000 or 100,000 ppm UNO and anti-mPD-1 demonstrated more than a doubling in survival versus anti-mPD-1 alone, presented at the
AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
- First-in-human data presented at the
- Autism Spectrum Disorder (ASD) Program
- Announced pre-clinical data demonstrating a therapeutic effect for at least 10 days after a single subcutaneous injection of an extended-release selective neuronal nitric oxide synthase (nNOS) inhibitor
- Plan to initiate a first-in-human study for treatment of ASD in 2025
Financial Results for the Fiscal Quarter Ended
Revenues for the three months ended
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
Net loss attributed to common stockholders for the three months ended
Total cash burn in the quarter ended
As of
Conference Call & Webcast
1-877-407-0784 (Domestic)
1-201-689-8560 (International)
Call me - https://callme.viavid.com/viavid/?callme=true&passcode=13738837&h=true&info=company-email&r=true&B=6
Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me™ link for instant telephone access to the event.
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1640134&tp_key=2d5ff9123d
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 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
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-
CONTACTS:
Investor Relations contacts
Head of Investor Relations
ebarger@beyondair.net
Cdavis@lifesciadvisors.com
(212) 915-2577
Media contacts
Head of Marketing
ktaylor@beyondair.net
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
(amounts in thousands, except share and per share data) | |||||||
2023 | 2023 | ||||||
(Unaudited) | |||||||
ASSETS | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 13,179 | $ | 29,158 | |||
Marketable securities | 25,463 | 16,724 | |||||
Restricted cash | 5,231 | 10,129 | |||||
Accounts receivable | 205 | - | |||||
Inventory, net | 1,574 | 1,129 | |||||
Grant receivable | - | 420 | |||||
Other current assets and prepaid expenses | 1,481 | 1,850 | |||||
Total current assets | 47,134 | 59,410 | |||||
Licensed right to use technology | 1,529 | 1,632 | |||||
Right-of-use lease assets | 2,294 | 2,493 | |||||
Property and equipment, net | 6,824 | 5,003 | |||||
Other assets | 224 | 212 | |||||
TOTAL ASSETS | $ | 58,005 | $ | 68,749 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities | |||||||
Accounts payable | $ | 3,292 | $ | 2,016 | |||
Accrued expenses | 8,496 | 16,613 | |||||
Operating lease liability, current portion | 391 | 376 | |||||
Loans payable, current portion | 275 | 775 | |||||
Total current liabilities | 12,454 | 19,780 | |||||
Operating lease liability, net | 2,087 | 2,321 | |||||
Long-term debt | 14,044 | 120 | |||||
Warrant Liability | 238 | - | |||||
Derivative liability | 349 | - | |||||
Other long-term liabilities | - | 4,500 | |||||
Total liabilities | 29,173 | 26,721 | |||||
Stockholders’ equity | |||||||
Preferred Stock, | - | - | |||||
Common Stock, | 3 | 3 | |||||
(25 | ) | (25 | ) | ||||
Additional paid-in capital | 235,495 | 217,339 | |||||
Accumulated deficit | (209,770 | ) | (179,455 | ) | |||
Accumulated other comprehensive income | 43 | 53 | |||||
Total stockholders’ equity attributable to | 25,746 | 37,915 | |||||
Non-controlling interests | 3,085 | 4,113 | |||||
Total equity | 28,831 | 42,028 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 58,005 | $ | 68,749 |
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 Six Months Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Revenue | $ | 239 | $ | - | $ | 298 | $ | - | |||||||
Cost of revenue | 432 | 179 | 735 | 179 | |||||||||||
Gross loss | (193 | ) | (179 | ) | (437 | ) | (179 | ) | |||||||
Operating expenses: | |||||||||||||||
Research and development | (7,130 | ) | (4,452 | ) | (11,826 | ) | (7,678 | ) | |||||||
General and administrative | (10,211 | ) | (7,990 | ) | (21,147 | ) | (16,203 | ) | |||||||
Operating expenses | (17,342 | ) | (12,442 | ) | (32,972 | ) | (23,882 | ) | |||||||
Operating loss | (17,535 | ) | (12,621 | ) | (33,410 | ) | (24,061 | ) | |||||||
Other income (loss) | |||||||||||||||
Dividend/interest income and gains on marketable securities | 641 | 1,050 | - | ||||||||||||
Interest expense | (914 | ) | (48 | ) | (1,072 | ) | (96 | ) | |||||||
Change in fair value of warrant liability | 324 | - | 647 | - | |||||||||||
Change in fair value of derivative liability | 500 | - | 1,012 | - | |||||||||||
Foreign exchange loss | (42 | ) | (217 | ) | (34 | ) | (394 | ) | |||||||
Estimated liability for contingent loss | (400 | ) | - | (598 | ) | - | |||||||||
Other income / (expense) | - | 88 | (77 | ) | 99 | ||||||||||
Total other income (expense) | 109 | (177 | ) | 929 | (391 | ) | |||||||||
Benefit from income taxes | - | - | - | - | |||||||||||
Net loss | $ | (17,426 | ) | $ | (12,797 | ) | $ | (32,481 | ) | $ | (24,452 | ) | |||
Less : net loss attributable to non-controlling interests | (1,205 | ) | (830 | ) | (2,165 | ) | (1,550 | ) | |||||||
Net loss attributable to | (16,220 | ) | (11,968 | ) | (30,315 | ) | (22,902 | ) | |||||||
Foreign currency translation gain/(loss) | (35 | ) | 171 | (9 | ) | 343 | |||||||||
Comprehensive loss attributable to | $ | (16,255 | ) | $ | (11,797 | ) | $ | (30,325 | ) | $ | (22,559 | ) | |||
Net basic and diluted loss per share attributable to | $ | (0.51 | ) | $ | (0.40 | ) | $ | (0.96 | ) | $ | (0.77 | ) | |||
Weighted average number of shares, outstanding, basic and diluted | 31,800,492 | 29,898,825 | 31,592,880 | 29,893,414 |
Source: Beyond Air™
2023 GlobeNewswire, Inc., source