AIT Therapeutics Enters Letter of Intent to License Revolutionary Nitric Oxide (NO) Delivery System and Adds Two Key Executives with Unparalleled Achievements in Developing NO Delivery Systems

System Generates Nitric Oxide on Demand at Concentrations of 1-400 parts per million

Fred Montgomery joins AIT as Vice President of Medical Systems

Duncan Bathe joins AIT as Vice President of Engineering

NEW YORK, Nov. 01, 2017 (GLOBE NEWSWIRE) -- AIT Therapeutics (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 it has entered into a letter of intent to acquire a global, exclusive, transferable license to the eNOGenerator and associated critical assets including intellectual property, know-how, trade secrets and confidential information from NitricGen, Inc.

“This system has the potential to be transformative for the delivery of NO in any setting, and we have already completed extensive work incorporating the generator with the AIT system,” stated Steve Lisi, chairman and chief executive officer of AIT Therapeutics. “Additionally, we welcome two outstanding executives, Fred Montgomery and Duncan Bathe, to AIT giving us the most elite NO systems team in the industry.”

Key highlights of the technology and anticipated transaction:

  • The AIT NO delivery system, which now incorporates the eNOGenerator, is designated a medical device at the Food and Drug Administration (FDA)
  • The eNOGenerator can generate NO on demand for delivery to the lungs at concentrations ranging from 1 part per million (ppm) to 400 ppm
    • AIT can, with the proposed license, target all conditions requiring NO at any concentration, regardless of the need for intermittent or continuous dosing
  • The elimination of large, high-pressure cylinders for NO is a significant advantage in the hospital setting and potentially allows for use in the home setting
    • In the hospital setting, there would be no inventory or storage requirements, added equipment, purging procedures or external oxygen necessary
    • The NO generator system weighs approximately 7lbs for high concentration delivery and scales down to lower weights for lower concentrations to allow for convenient home use
  • The addition of Fred Montgomery and Duncan Bathe to the AIT team
    • Fred and Duncan have worked together for the last 24 years developing and patenting NO delivery system technology leading to the commercialization of NO therapy. They developed the NO delivery systems used in 2 of the 3 pivotal studies that led to the FDA drug approval of NO in 1999. They developed and patented the INOvent delivery system for Datex-Ohmeda, which required successfully petitioning the FDA to reclassify NO delivery systems from Class III to Class II medical devices and was key to the first FDA 510(k) clearance and commercial marketing in the year 2000. In 2003, they left Datex-Ohmeda to join INO Therapeutics (now owned by Mallinckrodt) to establish their Medical Device Group. While there, they led the development of the INOmax DS and DSIR products, which are the dominant NO delivery systems in the United States to this day. In addition, while at INO Therapeutics, they developed and patented the INOpulse delivery system for chronic home use of NO, which is now in clinical trials with Bellerophon Therapeutics. Fred and Duncan left INO Therapeutics in 2011 and formed NitricGen Inc., where they developed and patented the NO generator technology, with the goal of liberating clinicians and patients from the burdens of large, heavy, high-pressure cylinders which are the basis of NO therapy today. Together they are inventors on over 30 patents in the area of NO delivery systems and are among the preeminent technology experts in this field.
  • Financial terms of the transaction
    • AIT will pay NitricGen $2 million in up-front, clinical, and regulatory milestone payments combined, with the majority of this amount pertaining to regulatory milestones
    • Low single-digit royalty on sales of the delivery system containing the generator
    • Warrants to purchase an aggregate of 100,000 shares of AIT common stock at a strike price of $6.90 per share

We plan to use the final commercial device in our pivotal trials in NTM and bronchiolitis, both of which are expected to begin in the second half of 2018.

About AIT Therapeutics Inc.
AIT 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.

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, and include without limitation, statements relating to the intent of the company and NitricGen to enter into a definitive license agreement, the potential for transformation of the delivery of NO in any setting, and plans to use the final commercial device in pivotal trials. 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 important 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

 

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