false
0001641631
0001641631
2026-10-08
2026-10-08
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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): October 8, 2026
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
2.02. Results of Operations and Financial Condition.
On
October 8, 2026, Beyond Air, Inc. (the “Company”) issued a press release announcing preliminary, unaudited revenue for the
quarter ended September 30, 2026 and reaffirming its previously issued revenue guidance for calendar years 2026 and 2027. A copy of the
press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
This
information, including the exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall
be expressly set forth by specific reference in such filing.
The
preliminary revenue and information disclosed in Exhibit 99.1 is unaudited and is based on management’s preliminary estimates and
information available to the Company as of the date of the press release. This information remains subject to completion of the Company’s
financial closing procedures and review of its interim financial statements. The Company’s independent registered public accounting
firm has not audited, reviewed or performed any procedures with respect to the preliminary revenue information. Actual revenue ultimately
reported by the Company may differ materially from these preliminary estimates. The Company expects to report its complete financial
results for the quarter ended September 30, 2026 in November 2026.
Item
7.01. Regulation FD Disclosure.
The
information under Item 2.02 above is incorporated herein by reference.
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 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
Exchange Act, or otherwise subject to the liabilities under that section. In addition, the information in this Item 7.01 disclosure,
including Exhibit 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 from Beyond Air, Inc., dated as of October 8, 2026. |
| 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:
October 8, 2026 |
By: |
/s/
Daniel Moorhead |
| |
Name: |
Daniel
Moorhead |
| |
Title |
Chief
Financial Officer |
Exhibit 99.1
Beyond
Air® Preannounces Preliminary Revenue for the Quarter Ended September 30, 2026
Preliminary
revenue of $2.3 million represents the highest quarterly revenue reported, and approximately 30% sequential quarterly growth and 27%
growth over the same period last year
Performance
reflects continued adoption for first-generation LungFit PH; second-generation system remains under FDA review
Reaffirms
revenue guidance of $8 million for CY2026 and $16-$18 million for CY2027
GARDEN
CITY, N.Y., October 8, 2026 – Beyond Air, Inc. (NASDAQ: XAIR) (“Beyond Air” or the “Company”), a commercial-stage
medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve patients’ lives, today
announced preliminary, unaudited revenue of approximately $2.3 million for the quarter ended September 30, 2026. The preliminary revenue
represents an increase of approximately 30% compared with the quarter ended June 30, 2026 and 27% compared with the same quarter last
year, and reflects the successful rollout of the Company’s enhanced commercial execution strategy for LungFit PH.
“Our
strong revenue growth in the quarter ended September 30, 2026 reflects continued adoption of LungFit PH and the value hospitals see in
our cylinder-free nitric oxide technology,” said Robert Goodman, Chief Executive Officer of Beyond Air. “Over the years,
we have refined our first-generation system through a series of enhancements and improvements for ease of use. The first-generation LungFit
PH has established a strong track record of reliable nitric oxide delivery and has become a trusted system among our hospital customers.
Our second-generation system remains under review by the FDA, and we expect demand for the LungFit PH platform to increase significantly
following FDA approval. We continue to be pleased with the progress we are seeing with the ongoing PMA supplement process. Adding transport
capability will qualify Beyond Air as a single source nitric oxide provider, which is the current standard across most U.S. hospital
systems.”
Revenue
Guidance for CY2026 and CY2027
The
Company reaffirms its previously issued revenue guidance of $8 million for calendar year 2026, which excludes revenue from the second-generation
LungFit PH system. The Company also reaffirms its revenue guidance of $16 million to $18 million for calendar year 2027, which includes
anticipated revenue from the second-generation system, pending FDA approval.
The
preliminary revenue figure set forth above is unaudited, is based on management’s preliminary estimates and information available
to the Company as of the date of this press release, and remains subject to the completion of the Company’s financial closing procedures
and the review of its interim financial statements by its independent registered public accounting firm, which has not audited, reviewed
or performed any procedures with respect to the preliminary figure. Actual results may differ materially from the preliminary figure.
The
Company will report its complete financial results for the quarter ended September 30, 2026 in November 2026.
About
Beyond Air®, Inc.
Beyond
Air is a commercial-stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous
nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The
Company has received FDA approval and CE Mark for its first system, LungFit PH, for the treatment of term and near-term neonates with
hypoxic respiratory failure. For more information, visit www.beyondair.net.
About
LungFit®
Beyond
Air’s LungFit is a cylinder-free, phasic flow generator and delivery system designated as a medical device by the U.S. 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 ppm to 80 ppm. The LungFit 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 by eliminating NO2 purging steps, and offering other operational benefits.
LungFit
can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting
(e.g., COVID-19, bronchiolitis) and chronic, refractory lung infections in the home setting (e.g., NTM). With the elimination of cylinders,
Beyond Air intends to offer NO treatment in the home setting.
About
Nitric Oxide
Nitric
Oxide (NO) is a potent molecule, naturally synthesized in the human body, 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. Currently,
exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension
of the newborn to treat hypoxemia. 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 pathogens.
Forward-Looking
Statements
This
press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of
1995. These statements include, but are not limited to, statements regarding the Company’s preliminary, unaudited revenue for the
quarter ended September 30, 2026; the Company’s revenue guidance for calendar year 2026 and 2027; demand for, and hospital adoption
of, the Company’s LungFit PH systems; the FDA’s review of the Company’s PMA supplement for the second-generation LungFit
PH system and the potential approval, intended use and commercial benefits of that system; and the Company’s ability to scale its
infrastructure. Forward-looking statements may be identified by words such as “anticipate,” “believe,” “expect,”
“intend,” “plan,” “potential,” “will,” “would,” “could,” “may,”
and similar expressions, or by the use of future tense.
Because
forward-looking statements relate to future events, they are subject to inherent risks and uncertainties, many of which are beyond the
Company’s control, that could cause actual results to differ materially from those expressed or implied in such statements. These
risks and uncertainties include, but are not limited to, the possibility that the Company’s final revenue for the quarter ended
September 30, 2026 differs from the preliminary figure as a result of the completion of its financial closing procedures, final adjustments
or other developments; the Company’s ability to achieve its revenue guidance, which is based on assumptions regarding demand, hospital
adoption, pricing and other factors that may not be realized; whether the FDA approves the Company’s PMA supplement for the second-generation
LungFit PH system, which may not occur in a timely manner or at all; market acceptance of the Company’s products and competition
in the nitric oxide market; the Company’s ability to obtain the financing necessary to fund its operations and to satisfy its debt
obligations as they come due; the Company’s ability to maintain the listing of its common stock on The Nasdaq Stock Market; and
other risks described in the “Risk Factors” section of Beyond Air, Inc.’s most recent Annual Report on Form 10-K and
subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it
is made and, except as required by law, the Company undertakes no obligation to update or revise any forward-looking statement, whether
as a result of new information, future events or otherwise.
CONTACTS:
Investor
Relations contact
Corey
Davis, Ph.D.
LifeSci
Advisors, LLC
cdavis@lifesciadvisors.com
(212)
915-2577
