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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 7, 2023
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
communications 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
8.01. Other Events.
On
September 7, 2023, Beyond Air, Inc. (the “Company”) issued a press release (the “Press Release”) announcing its
entry into a distribution agreement (the “Agreement”) with Getz Healthcare to commercialize the Company’s LungFit PH
device in certain countries across the Asia Pacific region. Under the terms of the Agreement, Getz Healthcare will make a milestone payment
of $1,000,000 to the Company on or before 90 business days following CE mark certification of LungFit PH in Europe, and the Company will
further receive ongoing royalty payments based on net sales at percentages starting in the low double-digits and peaking at 20 percent.
A copy of the Press Release is attached hereto and incorporated herein by reference in its entirety as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibits.
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 7, 2023 |
By:
|
/s/
Steven A. Lisi |
|
Name:
|
Steven
A. Lisi |
|
Title
|
Chief
Executive Officer |
Exhibit
99.1
Beyond
Air® and Getz Healthcare Enter Strategic Collaboration to
Commercialize LungFit PH in Asia-Pacific Region
Partnership
provides access to hospitals in key Asia-Pacific countries
Getz
Healthcare will make a payment to Beyond Air upon receipt of CE Mark
Beyond Air will receive
royalty payments based on net sales
Garden
City, NY, September 7, 2023 – Beyond Air, Inc. (NASDAQ: XAIR) (“Beyond Air” or the “Company”),
a commercial stage medical device and biopharmaceutical company focused on 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 (through its affiliate
Beyond Cancer, Ltd. (“Beyond Cancer”)), today announced that it has entered into an agreement with Getz Healthcare to commercialize
the LungFit PH device in certain countries across the Asia-Pacific region, pending regulatory approvals.
“This
partnership with Getz Healthcare expands the reach of Beyond Air’s innovative technology into key growth markets outside of
the United States,” stated Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “We are excited to work
with such a strong partner which is well positioned to maximize the potential for LungFit PH in the Asia-Pacific region.”
Under
the terms of the agreement, Getz Healthcare will make a milestone payment to Beyond Air following CE mark certification of LungFit
PH in the European Union. CE mark certification in Europe
provides a pathway to approval in certain countries across the Asia-Pacific region. In addition, Beyond Air will receive ongoing royalty payments based on net sales of LungFit PH.
The partnership provides access to hospitals in
Australia, New Zealand, Thailand, Philippines, Taiwan, Hong Kong, Malaysia, Pakistan, Singapore and Vietnam. Getz Healthcare will
manage the logistics, sales, service, and maintenance process in each of these countries where they have extensive experience with
medical device distribution and hospital sales. Also, Getz Healthcare’s regulatory team will handle local product registration
in addition to customer service and support. Beyond Air will provide the LungFit PH device and all accessories on a cost-plus basis,
as well as providing other support services in areas such as marketing.
James
Simkins, CEO of Getz Healthcare, commented, “We are thrilled to announce our partnership with Beyond Air, a pivotal step forward
in Getz Healthcare’s unwavering commitment to deliver impactful healthcare solutions to the Asia-Pacific region. Together, we will
be pioneering innovative approaches in the delivery and access to nitric oxide therapy.”
BTIG,
LLC acted as the financial advisor to Beyond Air, Inc.
About
LungFit®PH*
Beyond
Air’s LungFit PH is a cylinder-free, phasic flow generator and delivery system that has received premarket approval (PMA) from
the U.S. Food and Drug Administration (FDA). The device is ventilator compatible and can generate NO from ambient air on demand for delivery
to the lungs at concentrations ranging from 1 ppm to 80 ppm. LungFit PH 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
with the elimination of NO2 purging steps, and other benefits. LungFit PH is the first and only FDA approved system with patented
Ionizer technology that generates nitric oxide using room air, enabling the delivery of unlimited, on-demand nitric oxide regardless
of dose and flow.
*
Beyond Air’s LungFit PH is currently approved for commercial use only in the United States of America to treat term and near-term
neonates with hypoxic respiratory failure.
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 for its first system, LungFit® PH for the treatment of term and near-term neonates
with hypoxic respiratory failure. Beyond Air is currently advancing its other LungFit systems in clinical trials for the treatment of
severe lung infections such as viral community-acquired pneumonia (including COVID-19), and nontuberculous mycobacteria (NTM). The Company
has also partnered with The Hebrew University of Jerusalem to advance a pre-clinicals program dedicated to the treatment of autism spectrum
disorder (ADS) and other neurological disorders. Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations
of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit www.beyondair.net.
About
Getz Healthcare
Getz
Healthcare is recognized as the leading distributor of medical equipment, devices, and consumables, in Asia Pacific. The company is an
ISO 9001:2015 certified company, and partners with leading manufacturers in medical technology, to offer a wide range of innovative and
high-quality products and solutions, enabling customers to focus on what is important – providing better care for patients. Headquartered
in Singapore, Getz Healthcare has been operating in the Asia Pacific region for over 110 years, serving over 7,500 customers, from 23
offices and distribution centers, spread across Australia, Hong Kong, Malaysia, New Zealand, Pakistan, Philippines, Taiwan, Thailand,
and Vietnam. Getz Healthcare is part of The Getz Group of companies. The company’s mission is to bring meaningful healthcare solutions
to the people of Asia Pacific.
Forward
Looking Statements
This
press release contains “forward-looking statements” concerning the Company’s expectations regarding the collaboration
with Getz Healthcare, the potential for LungFit PH device to be approved for commercialization in certain countries across the Asia Pacific
region; and the potential safety and efficacy of the Company’s products and product candidates. Forward-looking statements include
statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects.
You can identify such forward-looking statements by the words “appears,” “expects,” “plans,” “anticipates,”
“believes” “expects,” “intends,” “looks,” “projects,” “goal,”
“assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such
as “will,” “may,” “could,” “should” and the like) and by the fact that these statements
do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events,
activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred,
these statements are inherently subject to risks and uncertainties that could cause actual results to differ materially from any future
results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect views
as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results
to differ materially from the activities and results anticipated in forward-looking statements, including the timing and results of future
pre-clinical studies and clinical trials; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory
authorities, may not grant or may delay approval for our product candidates; the approach to discover and develop novel drugs, which
is unproven and may never lead to efficacious or marketable products; the ability to raise additional capital; the results of further
pre-clinical studies and clinical trials of our product candidates; obtaining, maintaining and protecting intellectual property utilized
by products; obtaining regulatory approval for products; competition from others using similar technology and others developing products
for similar uses; dependence on collaborators; and other risks, which may, in part, be identified and described in the “Risk Factors”
section of Beyond Air’s most recent Annual Report on Form 10-K and other of its filings with the Securities and Exchange Commission,
all of which are available on Beyond Air’s website. Beyond Air and Beyond Cancer undertake no obligation to update, and have no
policy of updating or revising, these forward-looking statements, except as required by applicable law.
CONTACTS:
Investor
Relations Contacts
Edward
Barger
Head
of Investor Relations
ebarger@beyondair.net
Corey
Davis, Ph.D.
LifeSci
Advisors, LLC
Cdavis@lifesciadvisors.com
Media
Contact
Kori-Ann
Taylor
Head
of Marketing
ktaylor@beyondair.net
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