Company: XAIR
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001641172-25-023243
Chunk: 94

Company: Beyond Air, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Part II, Item 8
Chunk 94
---
    our
    ability to build a pipeline of product candidates and develop and commercialize our approved products;

    ●
    our
    ability to enroll patients in clinical trials, timely and successfully complete those trials and receive necessary certifications
    or regulatory approvals;

    ●
    our
    ability to maintain our existing or future collaborations or licenses;

    ●
    our
    ability to protect and enforce our intellectual property rights;

    ●
    Federal,
    state, and foreign regulatory requirements, including the U.S Food and Drug Administration (“FDA”) regulation of our
    approved product and product candidates;

    ●
    our
    ability to obtain and retain key executives and attract and retain qualified personnel; and

    ●
    our
    ability to successfully manage our growth, including as a commercial-stage company.

Moreover,
we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management
to predict all risk factors and uncertainties.

You
should read this Form 10-Q and the documents that we reference in this Form 10-Q completely and with the understanding that our actual
future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary
statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained
herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Beyond
Air, Inc., the Beyond Air logo, and other trademarks or service marks of Beyond Air, Inc. appearing in this Form 10-Q are the property
of Beyond Air, Inc. This Form 10-Q also includes trademarks, tradenames and service marks that are the property of other organizations.
Solely for convenience, trademarks and tradenames referred to in this Form 10-Q appear without the ® and ™ symbols,
but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our
rights, or that the applicable owner will not assert its rights, to these trademarks and tradenames.

23

Introduction

We
are a commercial-stage medical device and biopharmaceutical company developing a platform of nitric oxide (“NO”) generators
and delivery systems (the “LungFit® platform”) capable of generating NO from ambient air. The Company’s
first device, LungFit® PH received premarket approval (“PMA”) from the FDA