Prioritizing U.S. Investigational Device Exemption (IDE) submission for use of the LungFit™ system in bronchiolitis (BRO) to facilitate completion of the pivotal LungFit™ BRO study in winter 2020/21
LungFit™ PH U.S. Premarket Approval (PMA) submission for the treatment of persistent pulmonary hypertension of the newborn (PPHN) expected calendar 1Q20
Third pilot study for LungFit™ BRO program initiated with several sites open and screening patients; results expected calendar mid-2020
LungFit™ At-Home nontuberculous mycobacteria (NTM) lung infection pilot study start targeted for Spring 2020; Patients to self-administer Nitric Oxide (NO) over a 12-week period
Animal toxicity studies support strong safety profile of high concentration NO
Save the date: March 5, 2020 Analyst Day in New York City
Conference Call scheduled for today, Wednesday, November 6th at 4:30 pm Eastern Time
GARDEN CITY, N.Y. and REHOVOT, Israel, Nov. 06, 2019 — Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled Nitric Oxide (NO) for the treatment of patients with respiratory conditions including serious lung infections and pulmonary hypertension, today announced its financial results for its fiscal second quarter ended September 30, 2019.
Recent Highlights and Upcoming Milestones
- During the quarter, the Company participated in an oral session at the 2019 European Respiratory Society (ERS) Conference where in vitro data were presented showing synergistic effects of NO in combination with clofazimine and amikacin against NTM abscessus bacteria, providing promise for a successful human study in 2020. The data were generated at Dr. Kenneth Olivier’s Laboratory of Chronic Airway Infection, Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health (NIH) in Bethesda, MD.
- Provided an update on high-concentration NO animal studies where NO was provided by the LungFit™ system. In a 30-day study with rats treated multiple times per day at NO concentrations of 150, 250 and 400 ppm, there were zero observations, macroscopic or microscopic, in any arm compared with control. In a 12-week rat study (dosing completed) and a 12-week dog study (10 weeks completed) with dosing of 250 ppm NO and frequency identical to that of the protocol for the upcoming LungFit™ NTM At-Home lung infection study, there are no macroscopic observations and we are awaiting the respective histopathology reports.
- Third BRO study opened on Nov. 3 and data are expected calendar mid-2020. The study will provide valuable information for the Company’s upcoming pivotal LungFit™ BRO study targeted for the 2020/21 winter in the United States.
- Anticipate submitting a PMA for LungFit™ PH for the treatment of (PPHN) in the first quarter of 2020, with an approval decision expected 180 days post submission, which will allow commercialization of the LungFit™ PH by the Company’s partner, Circassia Pharmaceuticals plc (Circassia), in the fall of 2020
- Expect to initiate a 12-week, self-administered, at-home study of LungFit™ NTM in the second quarter of calendar 2020
- Ended the quarter with $9.8 million in cash, cash equivalents, restricted cash and marketable securities
“Given the luxury of having three programs with significant clinical and commercial potential, we are elevating preparation and submission to the FDA of the IDE for our LungFit™ BRO pivotal study so that it can be completed in the 2020/21 winter, possibly accelerating the commercialization of LungFit™ BRO by one year. As a result, we are delaying by a few months our U.S. PMA submission for LungFit™ PH, with virtually no change to the expected launch timing,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “This allows us to maintain our scheduled start for the LungFit™ NTM At-Home study in the spring 2020. Given the robust safety profile to date, in both humans and now animals, our confidence is quite high for success in our high concentration NO LungFit™ programs and with success in the LungFit™ NTM At-Home study, we hope to treat patients with chronic, refractory, persistent lung infections of various types.”
Beyond Air’s goals over the next 18 months include:
- LungFit™ PH
- Submit a PMA in the first quarter of 2020
- Expect approval and launch of LungFit™ PH in the U.S. with Circassia in the fall of calendar 2020
- Endeavor to partner the LungFit™ PH in major ex-U.S. markets
- LungFit™ BRO
- Complete a pilot study in the second quarter of calendar 2020
- Initiate a pivotal study in the U.S. in the fourth quarter of calendar 2020, with anticipated completion in the second quarter of calendar 2021
- LungFit™ NTM
- Complete a multi-center, 12-week, self-administered, at-home pilot study, including patients infected with either Mycobacterium abscessus complex (MABSC) or Mycobacterium avium complex (MAC) at NO concentrations up to 250 ppm
Financial results for three months ended September 30, 2019
Revenue for the three months ended September 30, 2019 was $0.6 million, all of which was licensing revenue. No revenue was generated in the same three-month period of 2018.
Research and development expenses for the three months ended September 30, 2019 were $2.8 million, compared to $0.6 million in the three months ended September 30, 2018.
General and administrative expenses for the three months ended September 30, 2019 were $2.1 million, compared to $1.8 million for the same three-month period of 2018.
For the three months ended September 30, 2019, the Company had a net loss of $4.1 million, or $(0.38) per share, compared to a net loss of $2.4 million, or ($0.28) per share in the same three-month period of 2018.
As of September 30, 2019, the Company had cash, cash equivalents, restricted cash and marketable securities of $9.8 million.
| Conference Call & Webcast | |
| Wednesday, November 6 @ 4:30 pm Eastern Time | |
| Domestic: | 855-327-6837 |
| International: | 631-891-4304 |
| Passcode: | 10007938 |
| Webcast: | http://public.viavid.com/index.php?id=136733 |
About Nitric Oxide (NO)
Nitric Oxide (NO) is a powerful molecule 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 and is used in adult respiratory distress syndrome and persistent pulmonary hypertension of the neonate. 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 organisms, including mycobacteria, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.
About PPHN
Persistent pulmonary hypertension of the newborn (PPHN) is a lethal condition and a 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 (EMO) 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 the LungFit™ NO Generator and Delivery System**
Beyond Air’s NO Generator and Delivery System is a cylinder-free, phasic flow nitric oxide delivery system and has been designated as a medical device by the US 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 part per million (ppm) to 80 ppm. The NO Generator and Delivery 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. The system can also deliver NO at concentrations above 80 ppm for which intended treatments are: bronchiolitis in the hospital setting, and chronic, refractory lung infections in the home setting. For the first time, Beyond Air intends to offer NO treatment in the home setting with the elimination of cylinders.
** Beyond Air’s LungFit™ is not approved for commercial use and Beyond Air is not suggesting use over 80 ppm or use at home. Beyond Air’s LungFit™ is for investigational purposes only.
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 over 80 ppm NO, for which preliminary studies indicate may eliminate bacteria, viruses, fungi and other microbes from the lungs.
About NTM
Nontuberculous mycobacteria (NTM) is a rare and serious bacterial infection in the lungs causing debilitating pulmonary disease associated with increased morbidity and mortality. NTM infection is acquired by breathing in aerosolized bacteria from the environment, and if ignored can lead to NTM lung disease, a progressive and chronic condition. NTM is an emerging public health concern worldwide because of its multi-drug antibiotic resistance. Current treatment guidelines suggest a combination of multiple antibiotics delivered continually 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 for causing severe adverse events. Beyond Air’s system is designed to effectively deliver 160 – 400 ppm NO to the lung, and early data indicate that this range of NO concentration may have a positive effect on patients infected with NTM.
About Beyond Air, Inc.
Beyond Air, Inc. is a clinical-stage medical device and biopharmaceutical company developing a revolutionary NO Generator and Delivery System that uses NO generated from ambient air and delivers precise amounts of NO to the lungs for the potential treatment of respiratory and other diseases. The Beyond Air NO Delivery System can generate up to 400 ppm of NO for delivery either continuously or for a fixed amount of time and has the ability to either titrate dose on demand or maintain a constant dose. The Company is currently applying its therapeutic expertise to develop treatments for pulmonary hypertension in various settings, in addition to treatments for lower respiratory tract infections that are not effectively addressed with current standards of care. Beyond Air is currently advancing its revolutionary NO Generator and Delivery System in clinical trials for the treatment of bronchiolitis and severe lung infections such as nontuberculous mycobacteria (NTM). For more information, visit www.beyondair.net.
Forward-Looking Statement
This press release contains “forward-looking statements.” Forward-looking statements include statements about our expectations, beliefs, or intentions regarding our product offerings, business, financial condition, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “anticipates,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” “likely,” “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 our 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 our views as of the date they are made with respect to future events and financial performance. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: our approach to discover and develop novel drugs, which is unproven and may never lead to marketable products; our ability to fund and the results of further pre-clinical and clinical trials; obtaining, maintaining and protecting intellectual property utilized by our products; our ability to enforce our patents against infringers and to defend our patent portfolio against challenges from third parties; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of our product candidates, all of which are in early stages of development; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; our dependence on collaborators; and our short operating history. We undertake no obligation to update, and we do not have a policy of updating or revising, these forward-looking statements, except as required by applicable law.
CONTACT
Steven Lisi, Chief Executive Officer
Beyond Air, Inc.
Slisi@beyondair.net
Bob Yedid
LifeSci Advisors, LLC
Bob@LifeSciAdvisors.com
(646) 597-6989
BEYOND AIR, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, 2019 | March 31, 2019 | |||||
| (Unaudited) | ||||||
| ASSETS | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ | 1,895,389 | $ | 1,340,203 | ||
| Restricted cash | 459,234 | 16,934 | ||||
| Marketable securities | 7,485,819 | 6,542,667 | ||||
| Right-of-use lease assets | 58,267 | – | ||||
| Other current assets and prepaid expenses | 414,033 | 788,409 | ||||
| Total current assets | 10,312,742 | 8,688,213 | ||||
| Licensed right to use technology | 431,801 | 495,000 | ||||
| Right-of-use lease assets | 169,760 | – | ||||
| Property and equipment, net | 228,789 | 244,872 | ||||
| TOTAL ASSETS | $ | 11,143,092 | $ | 9,428,085 | ||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||
| Current liabilities | ||||||
| Accounts payable | $ | 2,104,323 | $ | 1,164,672 | ||
| Accrued expenses | 2,068,246 | 1,567,638 | ||||
| Deferred revenue | 990,223 | 2,263,294 | ||||
| Stock to be issued to a vendor | 138,000 | 144,000 | ||||
| Operating lease liability | 65,092 | – | ||||
| Loan payable | 88,582 | 263,604 | ||||
| Total current liabilities | 5,454,466 | 5,403,208 | ||||
| Long-term liabilities | ||||||
| Operating lease liability | 169,005 | – | ||||
| Total liabilities | 5,623,471 | 5,403,208 | ||||
| Commitments and contingencies | ||||||
| Shareholders’ 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: 100,000,000 shares authorized,10,746,780 and 8,714,815 shares issued and outstanding as of September 30, 2019 and March 31, 2019, respectively | 1,075 | 871 | ||||
| Treasury stock | (25,000 | ) | (25,000 | ) | ||
| Additional paid-in capital | 53,466,679 | 41,693,578 | ||||
| Accumulated deficit | (47,923,133 | ) | (37,644,572 | ) | ||
| Total shareholders’ equity | 5,519,621 | 4,024,877 | ||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 11,143,092 | $ | 9,428,085 | ||
BEYOND AIR, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
| For the Three Months Ended | For the Six Month Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| License revenues | $ | 645,602 | $ | – | $ | 1,273,071 | $ | – | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | (2,849,990 | ) | (647,866 | ) | (5,173,503 | ) | (1,711,011 | ) | ||||||||
| General and administrative | (2,064,872 | ) | (1,765,489 | ) | (4,247,430 | ) | (2,458,494 | ) | ||||||||
| Operating expenses | (4,914,862 | ) | (2,413,355 | ) | (9,420,933 | ) | (4,169,505 | ) | ||||||||
| Operating loss | (4,269,260 | ) | (2,413,355 | ) | (8,147,862 | ) | (4,169,505 | ) | ||||||||
| Other income (loss) | ||||||||||||||||
| Realized and unrealized gain (loss) from marketable securities | 142,806 | 2,805 | (2,164,513 | ) | 8,208 | |||||||||||
| Dividend income | 30,691 | 31,085 | 34,067 | 63,986 | ||||||||||||
| Foreign exchange loss | (1,977 | ) | (4,167 | ) | (253 | ) | (966 | ) | ||||||||
| Other expenses | – | (5,587 | ) | – | (9,289 | ) | ||||||||||
| Total other income (loss) | 171,520 | 24,136 | (2,130,699 | ) | 61,939 | |||||||||||
| Net loss | $ | (4,097,740 | ) | $ | (2,389,219 | ) | $ | (10,278,561 | ) | $ | (4,107,566 | ) | ||||
| Net basis and diluted loss per share | $ | (0.38 | ) | $ | (0.28 | ) | $ | (1.03 | ) | $ | (0.49 | ) | ||||
| Weighted average number of shares of common stock used in computing basic and diluted net loss per share | 10,699,370 | 8,440,457 | 9,935,444 | 8,420,281 | ||||||||||||
