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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of report (Date of earliest event reported): September 8, 2025
Beyond
Air, Inc.
(Exact
Name of Registrant as Specified in Charter)
Delaware |
|
001-38892 |
|
47-3812456 |
(State
or Other Jurisdiction
of
Incorporation) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
No.) |
900
Stewart Avenue, Suite 301
Garden
City, NY 11530
(Address
of Principal Executive Offices and Zip Code)
(516)
665-8200
Registrant’s
Telephone Number, Including Area Code
(Former
Name or Former Address, if Changed Since Last Report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐ |
Written
communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $.0001 per share |
|
XAIR |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405)
or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
7.01. Regulation FD Disclosure.
On
September 8, 2025, Beyond Air, Inc. (the “Company”) issued a press release announcing that NeuroNOS Limited (“NeuroNos”),
a wholly owned subsidiary of Beyond Air Ireland Limited, a wholly owned subsidiary of the Company, has been granted the Orphan Drug
Designation (ODD) to its lead investigational therapy, BA-101, for the treatment of Glioblastoma (GBM), by the U.S. Food and Drug Administration
(FDA).
A
copy of the press release is attached herewith as Exhibit 99.1.
By
filing this Current Report on Form 8-K and furnishing the information contained herein, the Company makes no admission as to the materiality
of any information in this report that is required to be disclosed solely by reason of Regulation FD. The Company uses, and will continue
to use, its website, press releases, and various social media channels, as additional means of disclosing public information to investors,
the media and others interested in the Company. It is possible that certain information that the Company posts on its website, disseminated
in press releases and on social media could be deemed to be material information, and the Company encourages investors, the media and
others interested in the Company to review the business and financial information that the Company posts on its website, disseminates
in press releases and on the social media channels identified above, as such information could be deemed to be material information.
The
information in this Item 7.01 disclosure, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the
liabilities under that Section. In addition, the information in this Item 7.01 disclosure, including Exhibits 99.1, shall not be incorporated
by reference into the filings of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly
set forth by specific reference in such filing.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
Exhibit
No.
|
|
Description |
99.1 |
|
Press Release of Beyond Air, Inc., dated September 8, 2025. |
104 |
|
Cover Page Interactive Data File (Embedded within the Inline XBRL document) |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
BEYOND
AIR, Inc. |
|
|
Date: September
8, 2025 |
By: |
/s/
Steven A. Lisi |
|
Name: |
Steven
A. Lisi |
|
Title |
Chief
Executive Officer |