Exhibit
99.1
Beyond
Air Reports Financial Results and Provides Corporate Update
for
the Quarter Ended September 30, 2026
Record
quarterly revenue of $2.3 million, representing approximately 28% year-over-year growth, reflecting continued adoption of first-generation
LungFit PH
PMA
supplement for second-generation LungFit PH system remains under FDA review; transport capability expected to drive greater market penetration,
pending approval
Reaffirms
revenue guidance of $8 million for CY2026 and $16–$18 million for CY2027
Conference
call today at 4:30 p.m. ET
GARDEN
CITY, N.Y., November 11, 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 financial results for the quarter ended September 30, 2026, and provided a corporate update.
“Building
on the commercial momentum we are generating with our first-generation LungFit PH system, we believe our second-generation system has
the potential to substantially expand our market opportunity and accelerate growth, pending FDA approval,” said Robert Goodman,
Chief Executive Officer of Beyond Air. “Our US pipeline is now experiencing unprecedented expansion with an acceleration in demand
for our first-generation system and high receptivity to our technology and its operational efficiencies, creating a natural demand for
our next generation product. We are especially pleased with the pace of new account wins and rate of renewals, which speak to the high
level of customer satisfaction with our unique technology – all of which we believe we can leverage into the potential future launch
of our second-generation LungFit PH system. Subject to FDA approval, the system is designed to provide a smaller footprint, reduced weight,
simplified operation, longer service intervals and expanded operational flexibility. The PMA supplement seeks expanded FDA labeling that
would permit use during patient transport by air and ground.”
Mr.
Goodman continued, “We remain encouraged by our active and productive discussions with the FDA and the progress we are making toward
completing the remaining steps in the review process for the second-generation LungFit PH system. We expect to complete our audit-readiness
process in mid-December, and subject to FDA inspections and final approval thereafter.”
Recent
Financial and Operating Highlights
| ● |
Reported
revenue of $2.3 million for the quarter ended September 30, 2026, the highest quarterly revenue in the Company’s history, representing
approximately 28% growth over the same period last year and 31% growth compared with the quarter ended June 30, 2026. |
| ● |
Executed
the Company’s enhanced commercial strategy for first-generation LungFit PH, supporting increased adoption of its cylinder-free
nitric oxide technology. |
| ● |
Advanced
preparations for the potential U.S. commercial launch of the second-generation LungFit PH system, subject to FDA approval. If approved,
the Company believes the addition of transport capability would enable Beyond Air to serve as a single-source nitric oxide provider
for hospitals and health systems. |
| ● |
Received
FDA Breakthrough Device Designation for LungFit GO for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD).
The Company does not plan to allocate resources to further development of LungFit GO until the commercial launch of second-generation
LungFit PH is well established, following FDA approval. |
| ● |
Announced
a definitive agreement under which UNIVO Pharmaceutical Industries Ltd. would acquire the Company’s controlling interest in
NeuroNOS Israel Ltd. The transaction is intended to provide NeuroNOS with dedicated resources, funding and strategic focus to advance
its development programs. |
| ● |
Evaluating
potential development partnerships and other strategic arrangements to support the continued advancement of Beyond Cancer’s
pipeline, while maintaining Beyond Air’s focus and resource allocation on its commercialization of LungFit PH. |
Pending
Regulatory Milestones
| ● |
The
PMA supplement for the second-generation LungFit PH system, submitted in June 2025, remains under FDA review. |
Financial
Results for the Quarter Ended September 30, 2026
Revenue
for the quarter ended September 30, 2026 was $2.3 million, compared with $1.8 million for the same period last year.
Research
and development expenses for the three months ended September 30, 2026 were $1.6 million as compared to $2.5 million for the three months
ended September 30, 2025. The decrease was primarily attributed to lower costs related to the second-generation LungFit PH as the majority
of development is complete.
Selling,
general and administrative expenses for the three months ended September 30, 2026 were $4.6 million as compared to $4.9 million for the
three months ended September 30, 2025. The decrease was attributed primarily to decreases in stock-based compensation costs, partially
offset by increased salaries in our sales organization as we build out our commercial team.
Other
expense for the three months ended September 30, 2026 was $2.2 million as compared to other expense of $0.6 million for the three months
ended September 30, 2025. The increase in expense was attributed primarily to an increase in the Company’s outstanding debt and
related interest expense, in addition to a charge for scrapped materials.
Net
loss attributed to common stockholders of Beyond Air, Inc. for the three months ended September 30, 2026 was $7.8 million, or a loss
of $3.76 per basic and diluted share, compared with a net loss of $7.9 million, or a loss of $24.98 per basic and diluted share, for
the three months ended September 30, 2025.
As
of September 30, 2026, the Company reported cash, cash equivalents, restricted cash and marketable securities of $18.5 million, including
$2.7 million of cash held by NeuroNos which is included within current assets held for sale on the balance sheet and $0.7 million of
cash held by Beyond Cancer. Restricted cash at September 30, 2026 was $4.8 million.
Financial
Guidance
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.
Conference
Call and Webcast
Wednesday,
November 11, 2026 at 4:30 p.m. ET
Domestic:
1-877-407-0784
International:
1-201-689-8560
Conference
ID: 13763626
Webcast:
A webcast of the live conference call can be accessed by visiting the Events section of the Company’s website (click here)
or directly (click here). An online replay will be available on the Company’s website or via the direct link an hour after
the call.
As
previously announced, and formally approved by the Board of Directors, the Company is transitioning its fiscal year end from March 31
to December 31, effective December 31, 2026. As a result, the Company expects to report financial results for the nine-month transition
period ending December 31, 2026 on a Form 10-K/T.
About
Beyond Air
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 revenue guidance for calendar year 2026
and 2027; demand for, and hospital adoption of, the Company’s LungFit PH systems, including the Company’s pipeline, new account
wins and renewals; the FDA’s review of the Company’s PMA supplement for the second-generation LungFit PH system, including
the expected timing of completion of the Company’s audit-readiness process and FDA inspections, and the potential approval, intended
use, transport capability, commercial launch and commercial benefits of that system; the proposed NeuroNOS transaction, its consideration,
closing conditions and anticipated benefits; development plans and resource allocation for LungFit GO; potential partnerships or other
strategic arrangements for Beyond Cancer; the Company’s liquidity, financing needs and ability to continue as a going concern;
the Company’s ability to scale its infrastructure; and the Company’s fiscal year-end transition and expected filing of a
transition report on Form 10-K/T. 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 Company’s ability to achieve its revenue guidance, which is based on assumptions regarding demand, hospital adoption, pricing,
the timing of FDA approval of the second-generation LungFit PH system and other factors that may not be realized; whether the Company
completes its audit-readiness process as anticipated; the timing and outcome of FDA inspections and whether the FDA approves the Company’s
PMA supplement for the second-generation LungFit PH system, including the requested transport labeling, which may not occur in a timely
manner or at all; delays in the commercial launch of the second-generation LungFit PH system; the Company’s reliance on third-party
contract manufacturers; market acceptance of the Company’s products and competition in the nitric oxide market; the possibility
that the contemplated investment or other conditions to the NeuroNOS transaction are not satisfied, that the transaction does not close
or its anticipated benefits are not realized, or that the value of the UNIVO securities is limited; the availability of resources for
LungFit GO, the outcome of further clinical development and regulatory review; the Company’s ability to secure and complete strategic
arrangements for Beyond Cancer; the Company’s history of losses and substantial doubt about its ability to continue as a going
concern; the Company’s ability to obtain the financing necessary to fund its operations and to satisfy its debt obligations as
they come due, and the dilution that any equity financing may cause; 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, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 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
BEYOND
AIR, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(in
thousands)
| | |
September 30, 2026 | | |
March 31, 2026 | |
| | |
(Unaudited) | | |
| |
| ASSETS | |
| | | |
| | |
| Current assets | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 5,397 | | |
$ | 6,740 | |
| Marketable securities | |
| 5,652 | | |
| 4,901 | |
| Restricted cash | |
| 4,832 | | |
| 5,622 | |
| Accounts receivable, net | |
| 1,450 | | |
| 1,086 | |
| Inventory, net | |
| 1,190 | | |
| 1,406 | |
| Other current assets and prepaid expenses | |
| 5,083 | | |
| 5,012 | |
| Current assets held for sale | |
| 3,024 | | |
| - | |
| Total current assets | |
| 26,628 | | |
| 24,767 | |
| | |
| | | |
| | |
| Licensed right to use technology | |
| 915 | | |
| 1,018 | |
| Right-of-use lease assets | |
| 1,003 | | |
| 1,193 | |
| Property and equipment, net | |
| 7,632 | | |
| 8,249 | |
| Other assets | |
| 77 | | |
| 158 | |
| TOTAL ASSETS | |
$ | 36,255 | | |
$ | 35,385 | |
| | |
| | | |
| | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| Current liabilities | |
| | | |
| | |
| Accounts payable | |
$ | 2,128 | | |
$ | 2,417 | |
| Accrued expenses and other current liabilities | |
| 4,094 | | |
| 3,372 | |
| Operating lease liability, current portion | |
| 211 | | |
| 321 | |
| Loans payable, current portion | |
| 58 | | |
| 401 | |
| Current liabilities held for sale | |
| 759 | | |
| - | |
| Total current liabilities | |
| 7,250 | | |
| 6,511 | |
| | |
| | | |
| | |
| Operating lease liability, net | |
| 899 | | |
| 1,023 | |
| Long-term debt, net | |
| 21,982 | | |
| 21,639 | |
| Warrant liability | |
| - | | |
| 2 | |
| Total liabilities | |
| 30,131 | | |
| 29,175 | |
| | |
| | | |
| | |
| Stockholders’ equity | |
| | | |
| | |
| Preferred Stock | |
| - | | |
| - | |
| Common Stock | |
| - | | |
| - | |
| Treasury stock | |
| (25 | ) | |
| (25 | ) |
| Additional paid-in capital | |
| 340,604 | | |
| 325,588 | |
| Accumulated deficit | |
| (335,324 | ) | |
| (319,571 | ) |
| Accumulated other comprehensive income | |
| 72 | | |
| 134 | |
| Total stockholders’ equity attributable to Beyond Air, Inc. | |
| 5,327 | | |
| 6,126 | |
| Non-controlling interest | |
| 797 | | |
| 84 | |
| Total stockholders’ equity | |
| 6,124 | | |
| 6,210 | |
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 36,255 | | |
$ | 35,385 | |
BEYOND
AIR, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in
thousands, except share and per share data)
(UNAUDITED)
| | |
For the Three Months Ended | | |
For the Six Months Ended | |
| | |
September 30, | | |
September 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| | |
| | |
| | |
| | |
| |
| Revenues | |
$ | 2,324 | | |
$ | 1,818 | | |
$ | 4,092 | | |
$ | 3,578 | |
| | |
| | | |
| | | |
| | | |
| | |
| Cost of revenues | |
| 2,127 | | |
| 2,116 | | |
| 3,670 | | |
| 3,720 | |
| | |
| | | |
| | | |
| | | |
| | |
| Gross profit (loss) | |
| 197 | | |
| (298 | ) | |
| 422 | | |
| (142 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
| 1,581 | | |
| 2,450 | | |
| 3,540 | | |
| 5,536 | |
| Selling, general, and administrative | |
| 4,591 | | |
| 4,913 | | |
| 9,469 | | |
| 9,600 | |
| Total operating expenses | |
| 6,172 | | |
| 7,363 | | |
| 13,009 | | |
| 15,136 | |
| | |
| | | |
| | | |
| | | |
| | |
| Loss from operations | |
| (5,975 | ) | |
| (7,661 | ) | |
| (12,587 | ) | |
| (15,278 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Other income/(expense): | |
| | | |
| | | |
| | | |
| | |
| Dividend/investment income | |
| 93 | | |
| 59 | | |
| 196 | | |
| 87 | |
| Interest and finance expense | |
| (1,504 | ) | |
| (639 | ) | |
| (2,996 | ) | |
| (1,187 | ) |
| Change in fair value of warrant liability | |
| 1 | | |
| (1 | ) | |
| 2 | | |
| 16 | |
| Foreign exchange gain/(loss) | |
| 29 | | |
| (18 | ) | |
| 69 | | |
| (59 | ) |
| Loss on extinguishment of debt | |
| (252 | ) | |
| - | | |
| (405 | ) | |
| - | |
| Loss on disposal of fixed assets | |
| - | | |
| (46 | ) | |
| (52 | ) | |
| (57 | ) |
| Loss on contract manufacturer’s inventory obsolescence | |
| (567 | ) | |
| - | | |
| (567 | ) | |
| - | |
| Other income | |
| - | | |
| 48 | | |
| 11 | | |
| 142 | |
| Total other expense | |
| (2,200 | ) | |
| (597 | ) | |
| (3,742 | ) | |
| (1,058 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Loss before income taxes | |
| (8,175 | ) | |
| (8,258 | ) | |
| (16,329 | ) | |
| (16,336 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Provision for income taxes | |
| - | | |
| - | | |
| - | | |
| - | |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss | |
$ | (8,175 | ) | |
$ | (8,258 | ) | |
$ | (16,329 | ) | |
$ | (16,336 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Less: net loss attributable to non-controlling interest | |
| (357 | ) | |
| (318 | ) | |
| (576 | ) | |
| (705 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss attributable to Beyond Air, Inc. | |
$ | (7,818 | ) | |
$ | (7,940 | ) | |
$ | (15,753 | ) | |
$ | (15,631 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Other comprehensive income/(loss), net of tax | |
| | | |
| | | |
| | | |
| | |
| Foreign currency translation adjustment | |
| (41 | ) | |
| 18 | | |
| (62 | ) | |
| 145 | |
| | |
| | | |
| | | |
| | | |
| | |
| Comprehensive loss attributable to Beyond Air, Inc. | |
$ | (7,859 | ) | |
$ | (7,922 | ) | |
$ | (15,815 | ) | |
$ | (15,486 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Net basic and diluted loss per share attributable to Beyond Air, Inc. (1) | |
$ | (3.76 | ) | |
$ | (24.98 | ) | |
$ | (11.22 | ) | |
$ | (54.95 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted average number of shares of common stock outstanding, basic and diluted (1) | |
| 2,078,853 | | |
| 317,829 | | |
| 1,403,780 | | |
| 284,471 | |
| Prior
period results have been adjusted to reflect the one-for-twenty reverse stock split in July 2026 |
