Form 8-K

8-K — Beyond Air, Inc.

Accession: 0001493152-26-046268

Filed: 2026-10-08

Period: 2026-10-08

CIK: 0001641631

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

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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): October 8, 2026

Beyond

Air, Inc.

(Exact

Name of Registrant as Specified in Charter)

Delaware

001-38892

47-3812456

(State

or Other Jurisdiction

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 ☐

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.

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.

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

EX-99.1

Filename: ex99-1.htm · Sequence: 2

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

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