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AIT Therapeutics Reports Financial Results for Three Months Ended

Key Takeaway: Therapeutics Reports Financial Results for Three Months Ended March 31, 2018 positive top-line data for Nitric Oxide in Bronchiolitis (NO-BRO) Pilot Study data from its inhaled Nitric Oxide study in patients infected with mycobacterium abscessus complex (MABSC) at the 2018 Amer

Full Press Release Details

Therapeutics Reports Financial Results for Three Months Ended March 31, 2018
positive top-line data for Nitric Oxide in Bronchiolitis (NO-BRO) Pilot Study
data from its inhaled Nitric Oxide study in patients infected with mycobacterium abscessus complex (MABSC) at the 2018 American
Thoracic Society Conference
IP with new patent for the Smart Filter for the nitric oxide generator and delivery system and patent allowance for delivery of
inhaled nitric oxide at concentrations of at least 160ppm for treatment of bronchiolitis in infants
Stephen J. DiPalma as Chief Financial Officer
Call scheduled for Thursday, June 14 at 8:30 a.m. Eastern Time
YORK, June 14, 2018 (GLOBE NEWSWIRE) - AIT Therapeutics, Inc. (OTC:AITB), a clinical-stage 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 financial results for the fiscal fourth quarter and year ended March 31, 2018.
Fourth Quarter and Recent Corporate Highlights:
Announced positive top-line data from its Nitric Oxide in Bronchiolitis (NO-BRO) Pilot Study in infants demonstrating a reduction in hospital length-of-stay of 21 hours
Presented data from its inhaled nitric oxide study in patients infected with mycobacterium abscessus complex (MABSC) at the 2018 American Thoracic Society Conference. Data demonstrated safety with no NO-related serious adverse events (SAEs) observed, as well as improvements in the 6-minute walk (6MW) test, a reduction in bacterial load, and improvements in quality-of-life and FEV 1.
Strengthened its intellectual property portfolio for the Company's Nitric Oxide Generator and Delivery system with a new patent grant. The patent, entitled: " Apparatus and Method for Generating Nitric Oxide in Controlled and Accurate Amounts ," covers the smart filter technology in the NO Generator and Delivery System that generates nitric oxide from room air.
Received patent allowance for delivery of inhaled nitric oxide at concentrations of at least 160ppm for the treatment of bronchiolitis in infants. The patent, entitled: " Inhalation of Nitric Oxide for Treating Respiratory Diseases " covers use in the treatment of bacterial, viral, and/or fungal bronchiolitis in addition to the intermittent delivery of NO. The claims are covered through March 7, 2033.
Named Stephen J. DiPalma as Chief Financial Officer
Previously reported information in the quarter include the signing of the definitive, exclusive, global license for the NOGen nitric oxide generator with NitricGen and a $9.8 million equity financing
are very pleased with the progress the Company has made over the past several months. We have positive top-line data from our
NO-BRO pilot study showing clear improvement in hospital length-of-stay in bronchiolitis patients; we presented positive data
from our NO-NTM study at the 2018 ATS conference; and we strengthened our patent portfolio surrounding our nitric oxide generator
and delivery system and the use of NO in treating bronchiolitis patients," said Mr. Steven Lisi, Chairman and Chief Executive
Officer. "Our team is continuing to execute the strategy which will improve the lives of patients and create value for our
shareholders. We anticipate submitting a 510k application in pulmonary hypertension around calendar year-end 2018; meeting with
the FDA to discuss the potential pivotal trial design in a NO-NTM study; and preparing to initiate a pivotal trial in bronchiolitis
in the fourth quarter of calendar year 2019."
results for three months ended March 31, 2018
Company announced a change in its Company's fiscal year end from December 31 to March 31. The change resulted in a three-month
transition period that began on January 1, 2018 and ended on March 31, 2018. The Company's 2019 fiscal year will commence
on April 1, 2018. As a result of the change, the following financial results reflect the three-month transition period ended March
the three months ended March 31, 2018, the Company posted net income of $1.0 million, or $0.15 per share. The Company had a $3.5
million benefit from the revaluation of warrants to purchase common stock, which is a non-cash item.
and development expenses were $1.6 million for the three months ended March 31, 2018. Expenses during the three month period were
due to costs related to clinical trials.
and administrative expenses were $0.8 million for the three months ended March 31, 2018.
income for the three months ended March 31, 2018 was $3.5 million, primarily due to the revaluation of the warrants to purchase
of March 31, 2018, the Company had cash and short-term deposits of $9.0 million. This cash balance reflects a financing in the
quarter that resulted in gross proceeds of $9.8 million.
Call & Webcast Information
June 14th @ 8:30am Eastern Time
Domestic: 866-575-6539
International: 323-794-2423
Passcode: 1819673
Webcast: http://public.viavid.com/index.php?id=130045
available through June 28th:
Domestic: 844-512-2921
International: 412-317-6671
Conference ID: 1819673
oxide (NO) is a powerful molecule proven to play a critical role in a broad array of biological functions. In the airways, NO
is believed to play a key role in the innate immune system at concentrations of approximately 200 ppm. In vitro studies suggest
that NO possesses anti-microbial activity not only against common bacteria, both gram-positive and gram-negative, but also against
other diverse organisms including mycobacteria, fungi, yeast and parasites, and has the potential to eliminate their multi-drug
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 160 ppm NO, which has been proven to eliminate
bacteria, viruses, fungi and other microbes from the lungs.
infection is a rare and serious condition causing debilitating pulmonary disease associated with increased morbidity and mortality.
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 over one to two years. These complex, expensive and invasive
regimens have a poor record in the treatment of MABSC. AIT's system is designed to effectively deliver 160 ppm NO, which
has been proven to eliminate bacteria, viruses, fungi and other microbes from the lungs and may work against antibiotic resistant
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 and is approved in dozens
of countries to improve oxygenation and reduce 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.
AIT Therapeutics Inc.
Therapeutics Inc. is a clinical-stage biopharmaceutical company using nitric oxide (NO) to treat respiratory and other diseases.
The Company is currently applying its therapeutic expertise to treat lower respiratory tract infections that are not effectively
addressed with current standards of care as well as pulmonary hypertension in various settings. AIT Therapeutics is currently
advancing its revolutionary NO respiratory targeted system in clinical trials for the treatment of bronchiolitis and nontuberculous
mycobacteria (NTM). For more information, visit www.AIT-Pharm.com.
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 "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.
Lisi, Chief Executive Officer
AIT Therapeutics, Inc.
LifeSci Advisors, LLC
dollars in thousands, except share and per share data
As of As of December 31,
March 31, 2018 2017 2016
ASSETS:
CURRENT ASSETS:
Cash and cash equivalents $ 733 $ 1,201 $ 7
Restricted cash 6 6 -
Marketable securities 8,304 606 -
Other accounts receivable and prepaid expenses 59 109 78
Total current assets 9,102 1,922 85
NON-CURRENT ASSETS:
Deferred private placement costs - - 90
Property and equipment, net 253 267 61
Total non-current assets 253 267 151
TOTAL ASSETS $ 9,355 $ 2,189 $ 236
dollars in thousands, except share and per share data
As of March 31, 2018 As of December 31, 2017 As of December 31, 2016
LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIENCY)
CURRENT LIABILITIES:
Bank loan $ - $ - $ 39
Trade payables 842 669 528
Other accounts payable 1,257 694 1,093
Loans from related parties and others 33 33 379
Total current liabilities 2,132 1,396 2,039
NON-CURRENT LIABILITIES:
Liability related to warrants 5,678 9,172 -
Convertible notes - - 2,895
TOTAL LIABILITIES 7,810 10,568 4,934
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY (DEFICIENCY)
Common Stock, $0.0001 par value per share - 100,000,000 and 11,665,085 shares authorized at March 31, 2018, December 31, 2017 and 2016, respectively 8,397,056, 6,097,254 and 2,207,449 shares issued and outstanding at March 31, 2018, December 31, 2017 and 2016, respectively 1 1 1
Preferred Stock, $0.0001 par value per share - 10,000,000 shares authorized at March 31, 2018, December 31, 2017 and 2016; 0 issued and outstanding shares at March 31, 2018, December 31, 2017 and 2016 - - -
Accumulated other comprehensive income (3 ) 2 -
Treasury shares (25 ) (25 ) -
Additional paid- in capital 32,141 23,260 8,874
Deficit accumulated (30,569 ) (31,617 ) (13,573 )
Total shareholders' equity (deficiency) 1,545 (8,379 ) (4,698 )
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIENCY) $ 9,355 $ 2,189 $ 236
STATEMENTS OF COMPREHENSIVE LOSS
dollars in thousands, except share and per share data
For the Three months Ended March 31,
(Unaudited)
2018 2017
Operating expenses:
Research and development expenses $ 1,637 $ 1,439
General and administrative expenses 803 2,121
Costs related to aborted IPO - -
Operating loss 2,440 3,560
Financial (income) expense, net (3,488 ) 2,717
Loss (Income) before taxes on income (1,048 ) 6,277
Taxes on income - 6
Net (income) loss $ (1,048 ) $ 6,283
Net unrealized loss (gain) on available-for-sale investments 5 -
Total comprehensive (income) loss $ (1,043 ) $ 6,283
Net basic earnings (loss) per share of common stock $ 0.15 $ (1.12 )
Net diluted earnings (loss) per share of common stock $ 0.14 $ (1.12 )
Weighted average number of shares used in computing net basic earnings (loss) per share of common stock 7,196,048 5,617,762
Weighted average number of shares used in computing net diluted earnings (loss) per share of common stock 7,250,194 5,617,762
OF CONSOLIDATED CASH FLOWS
Last updated: Jun 19, 2018