Nexalin Technology, Inc. (the “Company” or “Nexalin”)
(Nasdaq: NXL; NXLIW) today provided a business update for
the year ended December 31, 2022.
Mark White, CEO of Nexalin Technology stated,
“Nexalin has made significant progress towards commencing clinical
trials of our Gen-2 and Gen-3 neurostimulation devices in the
United States. Nexalin’s enhanced neurostimulation devices combine
innovation, frequencies and algorithms to provide an unprecedented
solution for treating mental health disorders without the need for
medication. Although our Gen-1 device was previously cleared by the
U.S. Food and Drug Administration (FDA) to treat patients with
anxiety, depression, and insomnia, we believe that the new devices
will allow deeper penetration into the brain and provide enhanced
patient response without adverse side effects. Given changes in FDA
medical device requirements, the Company decided to not continue
with the Gen-1 device, given the success of the new devices, based
on both studies and approvals in China. Moreover, we are highly
encouraged by the preliminary data provided by the University of
California San Diego that supports the safety of utilizing our next
generation devices. As a result, we look forward to presenting our
new Gen-2 and Gen-3 devices to the FDA in the coming months for the
treatment of anxiety and insomnia. We are also on track to submit
our PMA with the FDA for the treatment of Major Depressive Disorder
(MDD) in Q3 2023. In addition, we seek to expand our
neurostimulation devices into new indications, such as substance
use disorder (addiction), Alzheimer’s, traumatic brain injury
(TBI), PTSD and chronic pain. Overall, we remain committed to our
mission of bringing our new, effective and drug-free therapy to
patients with mental health issues in the United States and around
the world.”
“Shortly after receiving the approval of our
Generation 2 (Gen-2) medical device by China’s National Medical
Products Administration (NMPA) for insomnia and depression, our
distributor, Wider Come Limited, commenced sales of our Gen-2
devices in China. Although we are pleased with our revenue growth
in 2022, our sales in China were greatly affected by the pandemic.
Despite this, our distributor continues to focus on selling the
instrument and disposables to key opinion leaders at leading
hospitals in China given the successful clinical studies and
validation by China’s NMPA in the areas of insomnia and depression.
We are highly encouraged by the interest and feedback in our
neurostimulation technology. Most recently, our neurostimulation
technology was featured in a white paper by the Second Xiangya
Hospital of Central South University, China, which further
validates that our Gen-2 device has the ability to significantly
improve mental healthcare outcomes among patients affected with
generalized anxiety disorder. As a result, we look forward to
advancing the commercial rollout, as well as conducting additional
clinical research studies in China across a number of different
indications. The clinical trials in China have been funded in their
entirety by our Chinese distributor.”
“In 2022, we succeeded in our goal of placing
Nexalin in a stronger financial position through the Initial Public
Offering and concurrent listing on the Nasdaq. As of December 31,
2022, we had cash, cash equivalents and short-term investments of
$7.0 million, which we believe provides us sufficient liquidity to
execute our business plan. As a result, we believe we are funded to
support FDA approval in the United States.”
Financial results
Nexalin has filed its Report on Form 10-K for
the year ended December 31, 2022 with the Securities and Exchange
Commission. A full copy of the filing can be obtained on the SEC’s
website at www.SEC.gov and on the Company’s website. We refer you
to the full filing for additional information regarding Nexalin and
its financial results and condition. We provide a brief summary of
our financial results for the year ended December 31, 2022
below.
Revenue for the year ended December 31, 2022 was
$1.3 million, compared to $0.1 million for the year ended December
31, 2021, an increase of $1.2 million. The increase in revenue for
2022 compared to 2021 was primarily due to increased device sales
in 2022.
Gross profit was $1.0 million for the year ended
December 31, 2022, compared to $0.1 million for the year ended
December 31, 2021.
Total operating expenses for the years ended
December 31, 2022 and 2021 were $2.8 million and $6.1 million,
respectively. The decrease was primarily due to a decrease in
stock-based compensation and professional fees. Loss from
operations the years ended December 31, 2022 and 2021 were $1.8
million and $6.0 million, respectively. Net loss for the years
ended December 31, 2022 and 2021 were $1.7 million or ($0.30) per
basic and diluted share, and $6.1 million or ($1.43) per basic and
diluted share, respectively.
As of December 31, 2022, the Company had cash,
cash equivalents and short-term investments of $7.0 million.
About Nexalin Technology,
Inc.
Nexalin designs and develops innovative neurostimulation
products to uniquely and effectively help combat the ongoing global
mental health epidemic. All Nexalin’s products are non-invasive and
undetectable to the human body and provide relief to those
afflicted with mental health issues without adverse side effects.
Nexalin utilizes bioelectronic medical technology to treat mental
health issues without the need for drugs or psychotherapy. Nexalin
believes its neurostimulation medical devices can penetrate
structures deep in the mid-brain that are associated with mental
health disorders. Nexalin believes the deeper penetrating waveform
in its next generation devices will generate enhanced patient
response without any adverse side effects. The Nexalin tACS device
was recently approved in China by the National Medical Products
Administration (NMPA) for the treatment of insomnia and depression.
In September 2018, Nexalin entered into a series of agreements with
Wider Come Limited (“Wider”), a company formed under the laws of
the People’s Republic of China. Pursuant to this agreement, Nexalin
and Wider have agreed to explore the formation of a joint venture
entity to be domiciled in Hong Kong. This new entity will conduct
clinical research and implement a business distribution plan for
the Nexalin device in the Asia Pacific region. Additional
information about the Company is available at:
https://nexalin.com/.
FORWARD-LOOKING STATEMENTS
This press release contains statements that
constitute "forward-looking statements," These statements relate to
future events or Nexalin’s future financial performance. Any
statements that refer to expectations, projections or other
characterizations of future events or circumstances or that are not
statements of historical fact (including without limitation
statements to the effect that Nexalin or its management “believes”,
“expects”, “anticipates”, “plans”, “intends” and similar
expressions) should be considered forward looking statements that
involve risks and uncertainties which could cause actual events or
Nexalin’s actual results to differ materially from those indicated
by the forward-looking statements. Forward-looking statements are
subject to numerous conditions, many of which are beyond the
control of the Company, including those set forth in the Risk
Factors section of the Company's Report on Form 10-K for the year
ended December 31, 2022 and other filings as filed with the
Securities and Exchange Commission. Copies of such filings are
available on the SEC's website, www.sec.gov. Such forward-looking
statements are made as of the date hereof and may become outdated
over time. Such forward-looking statements are made as of the date
hereof and may become outdated over time. The Company undertakes no
obligation to update these statements for revisions or changes
after the date of this release, except as required by law.
Contact:Crescendo Communications, LLCTel: (212)
671-1020Email: NXL@crescendo-ir.com
NEXALIN TECHNOLOGY, INC. AND
SUBSIDIARYCONSOLIDATED BALANCE SHEETS
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December 31, |
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2022 |
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|
2021 |
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ASSETS |
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Current Assets: |
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Cash and cash equivalents |
|
$ |
162,743 |
|
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$ |
661,778 |
|
Short-term investments |
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6,831,192 |
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- |
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Accounts receivable |
|
|
4,875 |
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16,303 |
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Inventory |
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|
154,370 |
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|
31,410 |
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Prepaid expenses and other current assets |
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|
272,282 |
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|
43,168 |
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Total Current Assets |
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7,425,462 |
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|
|
752,659 |
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ROU Asset |
|
|
6,171 |
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|
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- |
|
Equipment, net of accumulated depreciation of $2,181 and $29,862,
respectively |
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|
503 |
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|
1,039 |
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Total Assets |
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$ |
7,432,136 |
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$ |
753,698 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT) |
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Current Liabilities: |
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Accounts payable (Includes related party of $260,000 and $399,320,
respectively) |
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$ |
658,367 |
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$ |
843,794 |
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Accrued expenses |
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|
539,822 |
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|
|
611,795 |
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Lease liability, current portion |
|
|
50,797 |
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|
|
40,845 |
|
Loan payable - shareholder |
|
|
- |
|
|
|
37,200 |
|
Loan payable - officer |
|
|
200,000 |
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|
|
200,000 |
|
Note payable |
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|
500,000 |
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|
|
500,000 |
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Deferred revenue |
|
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- |
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|
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130,000 |
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Total Current Liabilities |
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1,948,986 |
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|
2,363,634 |
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Long-term Liabilities: |
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Lease liability, net of current portion |
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4,463 |
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|
49,089 |
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PPP Loan payable |
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- |
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|
|
22,916 |
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Total Liabilities |
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1,953,449 |
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|
|
2,435,639 |
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Commitments and Contingencies (Note 8) |
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Stockholders’ Equity (Deficit): |
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Common stock, $0.001 par value; 100,000,000 shares authorized;
7,286,562 and 4,879,923 shares issued and outstanding at December
31, 2022 and December 31, 2021, respectively |
|
|
7,287 |
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|
|
4,880 |
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Accumulated other comprehensive income |
|
|
36,313 |
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|
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- |
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Additional paid in capital |
|
|
77,824,427 |
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|
|
69,004,703 |
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Accumulated deficit |
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|
(72,389,340 |
) |
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|
(70,691,524 |
) |
Total Stockholders’ Equity (Deficit) |
|
|
5,478,687 |
|
|
|
(1,681,941 |
) |
Total Liabilities and Stockholders’ Equity
(Deficit) |
|
$ |
7,432,136 |
|
|
$ |
753,698 |
|
NEXALIN TECHNOLOGY, INC. AND
SUBSIDIARYCONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
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Year EndedDecember 31, |
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2022 |
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2021 |
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Revenues, net (Includes related party of $1,183,367 and $26,132 for
the year ended December 31, 2022 and December 31, 2021,
respectively) |
|
$ |
1,321,357 |
|
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$ |
144,065 |
|
Cost of revenues |
|
|
363,212 |
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|
|
21,442 |
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Gross profit |
|
|
958,145 |
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|
|
122,623 |
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Operating expenses |
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Professional fees |
|
|
605,329 |
|
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|
697,063 |
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Salaries and benefits |
|
|
694,108 |
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|
228,738 |
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Selling, general and administrative |
|
|
1,491,739 |
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|
5,215,423 |
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Total operating expenses |
|
|
2,791,176 |
|
|
|
6,141,224 |
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|
|
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Loss from operations |
|
|
(1,833,031 |
) |
|
|
(6,018,601 |
) |
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Other income (expense), net: |
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|
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Interest expense, net |
|
|
(59,382 |
) |
|
|
(82,319 |
) |
Other income |
|
|
171,681 |
|
|
|
- |
|
Forgiveness of PPP Loan |
|
|
22,916 |
|
|
|
22,916 |
|
Total other income (expense), net |
|
|
135,215 |
|
|
|
(59,403 |
) |
|
|
|
|
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Net loss |
|
|
(1,697,816 |
) |
|
|
(6,078,004 |
) |
Other comprehensive income: |
|
|
|
|
|
|
|
|
Unrealized gain from short-term investments |
|
|
36,313 |
|
|
|
- |
|
Comprehensive loss |
|
$ |
(1,661,503 |
) |
|
$ |
(6,078,004 |
) |
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|
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Net loss per share attributable to common stockholders - Basic and
Diluted |
|
$ |
(0.30 |
) |
|
$ |
(1.43 |
) |
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Weighted Average Shares Outstanding - Basic and Diluted |
|
|
5,572,402 |
|
|
|
4,256,360 |
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Grafico Azioni Nexalin Technologies (NASDAQ:NXL)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Nexalin Technologies (NASDAQ:NXL)
Storico
Da Giu 2023 a Giu 2024