Announces name change to
 
Beyond Air™

Completed uplisting to the NASDAQ and $7.96 million PIPE financing

Anticipate PMA submission in the third quarter of calendar 2019

Anticipate CE Mark in the first half of calendar 2020

Announced licensing agreement with Circassia Pharmaceuticals for commercial rights for hypoxic respiratory failure in the hospital setting in the United States and China

Strengthened management team with key hires

Conference Call scheduled for today, Tuesday, June 25 at 4:30 pm Eastern Time

GARDEN CITY, N.Y. and REHOVOT, Israel, June 25, 2019 (GLOBE NEWSWIRE) -- AIT Therapeutics, Inc. (NASDAQ: AITB), 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 fourth quarter and year ended March 31, 2019.

Fiscal Fourth Quarter and Year-End 2019 Highlights

  • AIT Therapeutics, commencing June 26, 2019, will be named Beyond Air. Please visit our current website at www.ait-pharm.com for further information.  Beyond Air™, The Magic of Breathing™
     
  • Completed an uplisting to the NASDAQ stock exchange and started trading on May 7, 2019 under its existing symbol AITB; Expects to trade under our new symbol, XAIR, starting July 15, 2019
     
  • Strengthened the company’s balance sheet with $7.96 million in funding through a private investment in public equity (PIPE) financing
     
  • Pilot study results published in the Journal of Cystic Fibrosis in May 2019, authored by Professor Lea Bentur, Director, Pediatric Pulmonary Institute, Rambam Medical Center, Haifa Israel, entitled, “Pilot study to test inhaled nitric oxide in cystic fibrosis patients with refractory Mycobacterium abscessus lung infection”.  The study demonstrated safety and tolerability of inhaled NO in cystic fibrosis patients with Mycobacterium abscessus lung infection and concluded that further evaluation is warranted given the improvement shown in quality of life, physical function and M. abscessus load
     
  • Presented NO Study and Poster at the International Society for Aerosols in Medicine (ISAM) 2019 Congress in Montreux, Switzerland from its study: “On-Demand Nitric Oxide for Ventilator-Based Nitric Oxide Inhalation: A Risk-Reduction Perspective”
     
  • AIT displayed the NO Generator and Delivery System at the Pediatric Academic Societies (PAS) Annual meeting  held in Baltimore, MD on April 27-30
     
  • Announced a $32.5 million commercial licensing agreement with Circassia Pharmaceuticals, for AIT’s novel, cylinder free, ventilator compatible nitric oxide (NO) generator and phasic-flow delivery system (AirNOvent*) in the United States and China for use in the hospital setting at NO concentrations <= 80 ppm.  The deal leverages Circassia’s expertise and footprint in specialty hospitals and the NO market and allows for a potential U.S. launch in the first half of calendar 2020. To date, AIT has received $10.5 million in milestone payments from Circassia in the form of stock and is entitled to over $22 million in future milestone payments and royalties on gross profits up to 20%
     
  • On track to file a Premarket Approval (PMA) submission with the FDA in the third quarter of calendar 2019 for the treatment of persistent pulmonary hypertension of the newborn (PPHN) with the AirNOvent*
     
  • Anticipate obtaining CE Mark in the first half of calendar 2020 with the AirNOvent* for PPHN and in pulmonary hypertension associated with heart surgery
     
  • Expect to initiate a 12-week, self-administered, at-home nontuberculous mycobacteria (NTM) study in the second quarter of calendar 2020
     
  • Since October 2018, strengthened the Company’s management team with several key hires in engineering, operations, and clinical development, including the additions of Douglas Beck as Chief Financial Officer and Duncan Fatkin as Chief Commercial Officer
     
  • Added to the Company’s Board of Directors with the appointment of Bob Carey, Chief Business Officer of Horizon Pharma plc, an executive with substantial experience in senior executive management roles and in healthcare investment banking

“Our fiscal fourth quarter capped a year of significant accomplishments for AIT as we progress towards gaining regulatory approvals in the US and EU in the first half of 2020,” said Steve Lisi, Chairman and Chief Executive Officer of AIT. “Along with our partner Circassia Pharmaceuticals, we anticipate a US launch of the AirNOvent* in the first half of 2020. Our programs in Bronchiolitis and NTM will both move forward in 2020 with data from two separate studies with the pivotal study for bronchiolitis anticipated to be completed in 2021 .”

Mr. Lisi continued, “As we look forward, we consider ourselves very fortunate to have the opportunity to bring our nitric oxide generator and delivery system to patients around the world for, not just our first three indications, but for several others as well, such as pseudomonas aeruginosa lung infection and chronic obstructive pulmonary disease (COPD).  I am confident that the team at AIT, soon to be the Beyond Air™ team, will continue to work tirelessly to help all patients who can benefit from NO therapy with our system.” 

AIT Goals for its programs over the next 18 months include:

  • PPHN (and cardiac surgery outside the United States)
       •   Submit a PMA to the FDA in the third quarter of calendar 2019
       •   Approval and launch in the U.S. with Circassia Pharmaceuticals expected in the first half of calendar 2020
       •   Obtain CE Mark in the first half of calendar 2020
       •   Endeavor to partner the AirNOvent* in major ex-US markets
     
  • Bronchiolitis
       •   Complete a pilot study in the second quarter of calendar 2020
       •   Initiate a pivotal study in the United States in the fourth quarter of calendar 2020 which would complete in the second quarter of calendar 2021
     
  • NTM
       •   Complete a multi-center pilot study in NTM, including both Mycobacterium abscessus complex (MABSC) and Mycobacterium avium complex (MAC), patients treated over a 12-week period using our NO generator and delivery system at concentrations up to 250 ppm with patients self-administering at home

Financial results for three months ended March 31, 2019
Revenue for the three months ended March 31, 2019 was $7.7 million, all of which is licensing revenue.  No revenue was generated in the same three-month period of 2018. 

Research and development expenses for the three months ended March 31, 2019 were $1.6 million, compared to $1.6 million in the same three-month period of 2018.

General and administrative expenses for the three months ended March 31, 2019 were $2.6 million, compared to $0.8 million for the same three-month period of 2018.

For the three months ended March 31, 2019, the Company had a net loss of $4.2 millon, or $(0.49) per share, compared to a net income of $1.0 million, or $0.15 per share in the same three-month period of 2018.

Financial results for twelve months ended March 31, 2019

Revenue for the twelve months ended March 31, 2019 was $7.7 million, all of which is licensing revenue.  No revenues was generated in the same twelve-month period of 2018. 

Research and development expenses for the twelve months ended March 31, 2019 were $3.9 million, compared to $4.6 million in the same twelve-month period of 2018.

General and administrative expenses for the twelve months ended March 31, 2019 were $6.9 million, compared to $5.3 million for the same twelve-month period of 2018.

For the twelve months ended March 31, 2019, the Company had a net loss of $10.7 million, or ($1.26) per share, compared to a net loss of $10.7 million, or ($1.68) per share in the same twelve-month period of 2018.

As of March 31, 2019, the Company had cash, cash equivalents, restricted cash and marketable securities of $7.9 million, compared to $9.0 million at March 31, 2018. On a pro forma basis as of June 3, the Company had cash, cash equivalents, restricted cash and marketable securities of $13.4 million.  This cash and marketable securities are sufficient to fund operations through calendar third quarter of 2020, exclusive of regulatory approval milestones.  

Conference Call & Webcast
Tuesday, June 25 @ 4:30 pm Eastern Time
Domestic:  877-407-0784
International:  201-689-8560 
Passcode:  13691695
Webcast:  http://public.viavid.com/index.php?id=134921

About AIT Therapeutics Inc.
AIT Therapeutics 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 AIT 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. AIT 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.AIT-Pharm.com.

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 NO Generator and Delivery System**
AIT’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, AIT intends to offer NO treatment in the home setting with the elimination of cylinders.

** AIT’s NO Generator and Delivery System is not approved for commercial use and AIT is not suggesting use over 80 ppm or use at home.  AIT’s NO Generator and Delivery System 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. AIT’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. AIT’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.

*AirNOvent may not be the final commercial name and refers only to the ventilator compatible version of our NO Generator and Delivery System

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
AIT Therapeutics, Inc.
Steve@AIT-Pharm.com

Bob Yedid
LifeSci Advisors, LLC
Bob@LifeSciAdvisors.com 
(646) 597-6989


AIT THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
 
  March 31, 2019 March 31, 2018 
      
ASSETS       
Current assets       
Cash and cash equivalents $1,340,203  $732,542 
Restricted cash  16,934   5,692 
Marketable securities  6,542,667   8,304,392 
Other current assets and prepaid expenses  788,409   59,249 
Total current assets  8,688,213   9,101,875 
Licensing right to use technology  495,000   - 
Property and equipment, net  244,872   253,184 
TOTAL ASSETS $9,428,085  $9,355,059 
        
LIABILITIES AND SHAREHOLDERS’ EQUITY       
Current liabilities       
Accounts payable $1,164,672  $842,039 
Accrued expenses  1,283,102   1,257,762 
Deferred revenue  2,263,294   - 
Stock to be issued to a vendor  144,000   - 
Loans from related parties and others  34,536   33,124 
Loan payable  263,604   - 
Total current liabilities  5,153,208   2,132,925 
        
Contingent liability  250,000     
Liabilities related to warrants  9,861,637   5,677,934 
Total long-term liabilities  10,111,637   5,677,934 
        
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, 8,714,815 and 8,397,056 shares issued and outstanding as of March 31, 2019 and March 31, 2018, respectively  871   840 
Treasury stock  (25,000)  (25,000)
Additional paid-in capital  41,693,578   32,141,110 
Accumulated deficit  (47,506,209)  (30,569,764)
Accumulated other comprehensive loss  -   (2,986)
Total shareholders’ equity  (5,836,760)  1,544,200 
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $9,428,085  $9,355,059 

 

 
AIT THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME
 
  Year Ended
March 31, 2019
 Year Ended
March 31, 2018
 
      
License revenue $7,724,001  $-  
        
Operating expenses       
Research and development  (3,929,558)  (4,636,287) 
General and administrative  (6,852,988)  (5,306,884) 
        
Operating loss  (3,058,545)  (9,943,171) 
        
Other income (loss)       
Change in fair value of warrant liabilities  (4,183,703)  (794,093) 
Realized and unrealized loss on available for sale marketable securities  (3,581,193)    
Dividend income  85,242   -  
Imputed interest with respect to convertible notes     3,495  
Amortization of debt issuance cost       
Foreign exchange loss  (920)  21,524  
Other expenses  (3,034)  (3,610) 
Total other income (loss)  (7,683,608)  (772,684) 
        
Net (loss) income $(10,742,153) $(10,715,855) 
        
        
Net (loss) income (loss) per share – basic and diluted $(1.26) $(1.68) 
        
Weighted average number of common shares outstanding – basic and diluted  8,498,525   6,391,218  
        


 
STATEMENTS OF CONSOLIDATED OPERATIONS AND COMPREHENISIVE LOSS (UNAUDITED)
 
  Three Months Ended
March 31, 2019
 Three Months Ended
March 31, 2018
License revenue $7,724,001  $- 
       
Operating expenses:      
Research and development expenses  (1,630,291) $(1,637,387)
General and administrative expenses  (2,580,199)  (803,069)
       
Operating income ( loss)  3,513,511   (2,440,456)
       
Other Income (Loss)      
Change in fair value of warrant liabilities  (4,183,703)  3,493,664 
Realized and unrealized loss on available for sale marketable securities  (3,581,193)  - 
Dividend income  10,519    
Foreign exchange gain (loss)  (632)  (4,521)
Other expense  (137)  (1,002)
Total other income (loss)  (7,755,146)  3,488,143 
       
Net loss and other comprehensive loss $(4,241,635) $1,047,687 
       
Net basic and diluted loss per share of common stock $(0.49) $0.15 
       
Weighted average number of shares used in computing net basic loss per share of common stock  8,602,479   7,196,048