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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON D.C. 20549
FORM 10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended September 30, 2024
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _______ to _______.
Commission file number: 001-41507
NEXALIN TECHNOLOGY, INC.
(Exact name of Registrant as specified in its charter)
Delaware |
|
27-5566468 |
(State or other jurisdiction of
incorporation or organization) |
|
(I.R.S. Employer
Identification No.) |
1776 Yorktown, Suite 550
Houston, TX 77056 |
| 77056 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including area code: (832) 260-0222
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 $0.001 per share |
|
NXL |
|
The Nasdaq Capital Market |
Warrants, exercisable for one share of Common Stock |
|
NXLIW |
|
The Nasdaq Capital Market |
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of large accelerated filer, accelerated filer, smaller reporting company, and emerging growth company in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer |
☐ |
Accelerated Filer |
☐ |
Non-Accelerated Filer |
☒ |
Smaller Reporting Company |
☒ |
|
|
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. Yes ☐ ☒
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of November 6, 2024, there were 12,861,605
shares of the Registrant’s common stock outstanding.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report
includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks,
uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially
from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Words
such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,”
“plan,” “targets,” “likely,” “aim,” “will,” “would,” “could,”
and similar expressions or phrases identify forward- looking statements. We have based these forward-looking statements largely on our
current expectations and future events and financial trends that we believe may affect our financial condition, results of operation,
business strategy and financial needs.
You should read thoroughly
this Quarterly Report with the understanding that our actual future results may be materially different from what we expect. We qualify
all of our forward-looking statements by risk factors included in our Registration Statement on Form S-1 (SEC File Number 333-279684)
as declared effective by the Securities and Exchange Commission (“SEC”) on June 27, 2024 and the Prospectus contained therein,
which risk factors could adversely impact our business and financial performance. New risk factors emerge from time to time and it is
not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent
to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking
statements. All forward-looking statements speak only as of the date on which they are made. We undertake no obligation to update such
statements to reflect events that occur or circumstances that exist after the date on which they are made, except as required by applicable
law.
NEXALIN TECHNOLOGY, INC. AND SUBSIDIARY
FORM 10-Q
For the Quarter Ended September 30, 2024
PART
I — FINANCIAL INFORMATION
Item 1. Financial Statements
NEXALIN TECHNOLOGY, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
| |
| | | |
| | |
| |
September 30, 2024 | | |
December 31, 2023 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 81,421 | | |
$ | 580,230 | |
Short-term investments | |
| 4,512,197 | | |
| 2,368,203 | |
Accounts receivable (Includes related party of $540 and $3,614, respectively) | |
| 15,171 | | |
| 9,369 | |
Inventory | |
| 158,375 | | |
| 156,420 | |
Prepaid expenses and other current assets | |
| 140,425 | | |
| 315,670 | |
Total Current Assets | |
| 4,907,589 | | |
| 3,429,892 | |
ROU Asset | |
| - | | |
| 496 | |
Intangible assets, net | |
| 248,942 | | |
| 105,528 | |
Equity method investment | |
| 100,651 | | |
| 96,000 | |
Total Assets | |
$ | 5,257,182 | | |
$ | 3,631,916 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 166,542 | | |
$ | 159,534 | |
Accrued expenses | |
| 132,847 | | |
| 261,284 | |
Lease liability, current portion | |
| - | | |
| 4,463 | |
Total Current Liabilities | |
| 299,389 | | |
| 425,281 | |
Total Liabilities | |
| 299,389 | | |
| 425,281 | |
| |
| | | |
| | |
Commitments and Contingencies (Note 7) | |
| | | |
| | |
| |
| | | |
| | |
Stockholders’ Equity: | |
| | | |
| | |
Common
stock, $0.001
par value; 100,000,000
shares authorized; 12,861,605
shares issued and outstanding at September 30, 2024 and 7,436,852
shares issued and outstanding at December 31, 2023 | |
| 12,862 | | |
| 7,437 | |
Accumulated other comprehensive loss | |
| (325 | ) | |
| (405 | ) |
Additional paid in capital | |
| 86,757,212 | | |
| 80,237,652 | |
Accumulated deficit | |
| (81,811,956 | ) | |
| (77,038,049 | ) |
Total Stockholders’ Equity | |
| 4,957,793 | | |
| 3,206,635 | |
Total Liabilities and Stockholders’ Equity | |
$ | 5,257,182 | | |
$ | 3,631,916 | |
The accompanying footnotes are an integral part of these unaudited condensed
consolidated financial statements.
NEXALIN TECHNOLOGY, INC. AND
SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited)
| |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended
September 30, | | |
Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenues, net (Includes related party of $868 and $0 for the three months ended and $3,102 and $10,207 for the nine months ended, respectively) | |
$ | 36,031 | | |
$ | 24,113 | | |
$ | 141,542 | | |
$ | 90,212 | |
Cost of revenues | |
| 12,694 | | |
| 3,973 | | |
| 29,097 | | |
| 20,457 | |
Gross profit | |
| 23,337 | | |
| 20,140 | | |
| 112,445 | | |
| 69,755 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Professional fees | |
| 262,303 | | |
| 127,202 | | |
| 731,099 | | |
| 405,949 | |
Salaries and benefits | |
| 294,175 | | |
| 363,330 | | |
| 928,072 | | |
| 965,988 | |
Selling, general and administrative | |
| 1,975,376 | | |
| 1,945,145 | | |
| 3,332,524 | | |
| 2,769,641 | |
Total operating expenses | |
| 2,531,854 | | |
| 2,435,677 | | |
| 4,991,695 | | |
| 4,141,578 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (2,508,517 | ) | |
| (2,415,537 | ) | |
| (4,879,250 | ) | |
| (4,071,823 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense), net: | |
| | | |
| | | |
| | | |
| | |
Interest income (expense), net | |
| 1,000 | | |
| (5,330 | ) | |
| 1,370 | | |
| (19,685 | ) |
Gain on sale of short-term investments | |
| 56,250 | | |
| 82,943 | | |
| 92,915 | | |
| 180,593 | |
Other income | |
| 2,851 | | |
| 40,735 | | |
| 6,407 | | |
| 42,875 | |
Total other income (expense), net | |
| 60,101 | | |
| 118,348 | | |
| 100,692 | | |
| 203,783 | |
| |
| | | |
| | | |
| | | |
| | |
Loss before equity in net earnings of affiliate | |
| (2,448,416 | ) | |
| (2,297,189 | ) | |
| (4,778,558 | ) | |
| (3,868,040 | ) |
Equity in net earnings of affiliate | |
| 159 | | |
| - | | |
| 4,651 | | |
| - | |
Net loss | |
| (2,448,257 | ) | |
| (2,297,189 | ) | |
| (4,773,907 | ) | |
| (3,868,040 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive income (loss): | |
| | | |
| | | |
| | | |
| | |
Unrealized gain (loss) from short-term investments | |
| (325 | ) | |
| (32,289 | ) | |
| 80 | | |
| (35,513 | ) |
Comprehensive loss | |
$ | (2,448,582 | ) | |
$ | (2,329,478 | ) | |
$ | (4,773,827 | ) | |
$ | (3,903,553 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share attributable to common stockholders - Basic and Diluted | |
$ | (0.23 | ) | |
$ | (0.31 | ) | |
$ | (0.55 | ) | |
$ | (0.53 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted Average Shares Outstanding - Basic and Diluted | |
| 10,847,476 | | |
| 7,415,366 | | |
| 8,606,357 | | |
| 7,330,128 | |
The
accompanying footnotes are an integral part of these unaudited condensed consolidated financial statements.
NEXALIN TECHNOLOGY, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (Unaudited)
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | |
| | |
Accumulated | | |
| | |
| | |
| |
| |
Common Stock | | |
Other
Comprehensive | | |
Additional
Paid-in | | |
Accumulated | | |
Total
Stockholders’ | |
| |
Shares | | |
Amount | | |
Gain (Loss) | | |
Capital | | |
Deficit | | |
Equity | |
Balance as January 1, 2023 | |
| 7,286,562 | | |
$ | 7,287 | | |
$ | 36,313 | | |
$ | 77,824,427 | | |
$ | (72,389,340 | ) | |
$ | 5,478,687 | |
Other comprehensive gain | |
| - | | |
| - | | |
| 4,756 | | |
| - | | |
| - | | |
| 4,756 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (748,414 | ) | |
| (748,414 | ) |
Balance as of March 31, 2023 | |
| 7,286,562 | | |
$ | 7,287 | | |
$ | 41,069 | | |
$ | 77,824,427 | | |
$ | (73,137,754 | ) | |
$ | 4,735,029 | |
Other comprehensive loss | |
| - | | |
| - | | |
| (7,980 | ) | |
| - | | |
| - | | |
| (7,980 | ) |
Stock compensation | |
| - | | |
| - | | |
| - | | |
| 88,388 | | |
| - | | |
| 88,388 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (822,437 | ) | |
| (822,437 | ) |
Balance as of June 30, 2023 | |
| 7,286,562 | | |
$ | 7,287 | | |
$ | 33,089 | | |
$ | 77,912,815 | | |
$ | (73,960,191 | ) | |
$ | 3,993,000 | |
Other comprehensive loss | |
| - | | |
| - | | |
| (32,289 | ) | |
| - | | |
| - | | |
| (32,289 | ) |
Stock compensation | |
| 150,000 | | |
| 150 | | |
| - | | |
| 1,573,020 | | |
| - | | |
| 1,573,170 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,297,189 | ) | |
| (2,297,189 | ) |
Balance as of September 30, 2023 | |
| 7,436,562 | | |
$ | 7,437 | | |
$ | 800 | | |
$ | 79,485,835 | | |
$ | (76,257,380 | ) | |
$ | 3,236,692 | |
| |
| | |
| | |
Accumulated | | |
| | |
| | |
| |
| |
Common Stock | | |
Other
Comprehensive | | |
Additional
Paid-in | | |
Accumulated | | |
Total
Stockholders’ | |
| |
Shares | | |
Amount | | |
Gain (Loss) | | |
Capital | | |
Deficit | | |
Equity | |
Balance as of January 1, 2024 | |
| 7,436,562 | | |
$ | 7,437 | | |
$ | (405 | ) | |
$ | 80,237,652 | | |
$ | (77,038,049 | ) | |
$ | 3,206,635 | |
Other comprehensive gain | |
| - | | |
| - | | |
| 160 | | |
| - | | |
| - | | |
| 160 | |
Stock compensation | |
| - | | |
| - | | |
| - | | |
| 161,349 | | |
| - | | |
| 161,349 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,041,157 | ) | |
| (1,041,157 | ) |
Balance as of March 31, 2024 | |
| 7,436,562 | | |
$ | 7,437 | | |
$ | (245 | ) | |
$ | 80,399,001 | | |
$ | (78,079,206 | ) | |
$ | 2,326,987 | |
Other comprehensive gain | |
| - | | |
| - | | |
| 245 | | |
| - | | |
| - | | |
| 245 | |
Stock compensation | |
| - | | |
| - | | |
| - | | |
| 308,283 | | |
| - | | |
| 308,283 | |
Shares issued | |
| 150,000 | | |
| 150 | | |
| - | | |
| (150 | ) | |
| - | | |
| - | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,284,493 | ) | |
| (1,284,493 | ) |
Balance as of June 30, 2024 | |
| 7,586,562 | | |
$ | 7,587 | | |
$ | - | | |
$ | 80,707,134 | | |
$ | (79,363,699 | ) | |
$ | 1,351,022 | |
Other comprehensive loss | |
| - | | |
| - | | |
| (325 | ) | |
| - | | |
| - | | |
| (325 | ) |
Stock compensation | |
| 2,275,043 | | |
| 2,275 | | |
| - | | |
| 1,536,894 | | |
| - | | |
| 1,539,169 | |
Shares issued in offering | |
| 3,000,000 | | |
| 3,000 | | |
| - | | |
| 4,513,184 | | |
| - | | |
| 4,516,184 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,448,257 | ) | |
| (2,448,257 | ) |
Balance as of September 30, 2024 | |
| 12,861,605 | | |
$ | 12,862 | | |
$ | (325 | ) | |
$ | 86,757,212 | | |
$ | (81,811,956 | ) | |
$ | 4,957,793 | |
The accompanying footnotes are an integral part of these unaudited condensed
consolidated financial statements.
NEXALIN
TECHNOLOGY, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
| |
| | | |
| | |
| |
Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (4,773,907 | ) | |
$ | (3,868,040 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Stock compensation | |
| 2,008,801 | | |
| 1,661,558 | |
Depreciation | |
| - | | |
| 402 | |
Amortization | |
| 10,666 | | |
| 2,105 | |
Non-cash lease expense | |
| 496 | | |
| 4,208 | |
Gain on sale of short-term investments | |
| (92,915 | ) | |
| (180,593 | ) |
Share of net income from equity method investment | |
| (4,651 | ) | |
| - | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (5,262 | ) | |
| (9,608 | ) |
Accounts receivable - related
party | |
| (540 | ) | |
| - | |
Prepaid assets | |
| 175,245 | | |
| 119,237 | |
Inventory | |
| (1,955 | ) | |
| (4,249 | ) |
Accounts payable - related party | |
| - | | |
| (260,000 | ) |
Accounts payable | |
| 7,008 | | |
| (325,818 | ) |
Accrued expenses | |
| (128,437 | ) | |
| 67,069 | |
Lease liability | |
| (4,463 | ) | |
| (37,625 | ) |
Net cash used in operating activities | |
| (2,809,914 | ) | |
| (2,831,354 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
Sale of short-term investments | |
| 22,348,611 | | |
| 32,671,394 | |
Purchase of short-term investments | |
| (24,399,610 | ) | |
| (29,270,926 | ) |
Purchase of patents | |
| (101,936 | ) | |
| (96,000 | ) |
Purchase of trademarks | |
| (52,144 | ) | |
| (74,460 | ) |
Net cash provided by (used in) investing activities | |
| (2,205,079 | ) | |
| 3,230,008 | |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
Payments on notes payable - officer | |
| - | | |
| (200,000 | ) |
Issuance of common stock | |
| 4,516,184 | | |
| - | |
Net cash provided by (used in) financing activities | |
| 4,516,184 | | |
| (200,000 | ) |
| |
| | | |
| | |
Net increase (decrease) in cash and cash equivalents | |
| (498,809 | ) | |
| 198,654 | |
Cash and cash equivalents - beginning of period | |
| 580,230 | | |
| 162,743 | |
Cash and cash equivalents - end of period | |
$ | 81,421 | | |
$ | 361,397 | |
| |
| | | |
| | |
Non-cash investing and financing activities: | |
| | | |
| | |
Unrealized gain (loss) on short-term investments | |
$ | 80 | | |
$ | (35,513 | ) |
The
accompanying footnotes are an integral part of these unaudited condensed consolidated financial statements.
NEXALIN
TECHNOLOGY, INC. AND SUBSIDIARY
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1 — NATURE OF THE ORGANIZATION AND BUSINESS
Corporate
History
Nexalin
Technology, Inc. (“NV Nexalin”) was formed on October 19, 2010 as a Nevada corporation. The Company’s principal
offices are located at 1776 Yorktown, Suite 550, Houston, Texas 77056.
On
September 6, 2019, Neuro-Health International, Inc. (“Neuro-Health”), a Nevada corporation, a wholly owned subsidiary
of NV Nexalin, was formed. Neuro-Health had no activity from December 6, 2019 (Inception) through September 30, 2024.
Our
shares and warrants began trading on the Nasdaq Capital Market tier of the Nasdaq Stock Market (“Nasdaq”) on September 16,
2022, under the symbols “NXL” and “NXLIW”, respectively.
On
July 1, 2024, we consummated a follow-on public offering of an aggregate of 3,000,000 shares of the Common Stock for an offering
price of $1.75 per share, resulting in aggregate net proceeds of approximately $4,720,000. The Company intends to use the
net proceeds of such offering primarily for general corporate purposes, which may include, but is not limited to, working capital, operating
expenses, and capital expenditures.
Throughout
this report, the terms “Nexalin,” “our,” “we,” “us,” and the “Company” refer
to Nexalin Technology, Inc.
Business
Overview
Nexalin
is headquartered, and maintains its base of management and operations, in Houston, Texas. We design and develop innovative neurostimulation
products to uniquely and effectively help combat the ongoing global mental health epidemic. We developed an easy-to-administer medical
device — referred to as “Generation 1” or “Gen-1” — that utilizes bioelectronic medical technology
to treat anxiety, insomnia, and depression, without the need for drugs or psychotherapy. Our original Gen-1 devices are cranial electrotherapy
stimulation (CES) devices that emit waveform at 4 milliamps during treatment and are presently classified by the U.S. Food and Drug Administration
(the “FDA”) as a Class II device.
Medical professionals in the United States have
utilized the Gen-1 device to administer to patients in clinical settings. While the Gen-1 device had been cleared by the FDA to treat
depression, anxiety, and insomnia, three prevalent and serious diseases, because of the FDA’s December 2019 reclassification
of CES devices, the Gen-1 device was reclassified as a Class II device for the treatment of anxiety and insomnia. We are required to
file a new application under Section 510(k) of the Federal Food, Drug and Cosmetic Act (“510(k) Application”) to be
approved by the FDA for the sales and marketing of our devices for the treatment of anxiety and insomnia. In the FDA’s December 2019
reclassification ruling, the treatment of depression with our device will require a Class III certification and require a new PMA (premarket
approval) and/or a new De Novo application to demonstrate safety and effectiveness.
While
we continue providing services to medical professionals to support patients’ use of the Gen-1 devices which were in operation prior
to December 2019, we are not making new sales or new marketing efforts of Gen-1 devices in the United States. We continue to derive
revenue from devices which we sold or leased prior to the FDA’s December 2019 reclassification announcements. This revenue
consists of monthly licensing fees and payments for the sale of electrodes and patient cables. We have suspended marketing efforts for
new sales of devices related to the Gen-1 device for treatment of anxiety and insomnia in the United States until the Nexalin regulatory
team decides on a new 510(k) application at 4 milliamps based on FDA comments expected to be received in late 2024. Our regulatory team
continues to inform the FDA of the suspension of the marketing and sale of the Gen-1 products to new providers. We are currently analyzing
whether to proceed with an amended application with the FDA for Gen-1 devices for the treatment of insomnia and anxiety.
The waveform that comprises the basis of our “Generation
2” or “Gen-2” and new “Generation 3” or “Gen-3” headset devices is in pre-submission for review
by the FDA for safety evaluation and eventual marketing in the United States. Determinations of the safety and efficacy of our devices
in the United States are solely within the authority of the FDA. We plan to conduct decentralized clinical trials for the Gen-3 device
in the U.S. and we continue to consult with the FDA as part of the pre-submission process. If and when we obtain FDA clearance for the
Gen-3 device, we intend to extend the development and commercialization of our devices for sale in the U.S. and other territories, given
the potential unmet demand for the treatment of mental health conditions with our device.
We have designed and developed a new advanced
waveform technology to be emitted at 15 milliamps through new and improved medical devices referred to as Gen-2 and Gen-3. Gen-2 is a
clinical use device with a modern enclosure to emit the new 15 milliamp advanced waveform. Gen-3 is a new patient headset that will be
prescribed by licensed medical professionals in a virtual clinic setting similar to existing tele-health platforms. The Nexalin research
team believes that the new 15 milliamp Gen-2 and Gen-3 devices can penetrate deeper into the brain and stimulate associated structures
of mental illness, which we believe will generate enhanced patient response without any risk or unpleasant side effects. The Nexalin regulatory
team has made a strategic decision to develop strategies for pilot trials and/or pivotal trials in various mental health disease categories.
In addition, a new PMA application in the United States is in strategic development for the treatment of depression utilizing both Gen-2
and Gen-3. We plan to schedule additional pilot trials and/or pivotal trials for the new Gen-3 device for anxiety and insomnia in the
United States and China beginning in the fourth quarter of 2024 . Preliminary data provided by The University of California,
San Diego and recent published data from Asia supports the safety of utilizing our 15 milliamp waveform technology. However, the determination
of safety and efficacy of medical devices in the United States is subject to clearance by the FDA.
Currently, the waveform that comprises the basis
of Gen-2 and new Gen-3 headset devices has been tested in research settings to develop safety data that has been submitted for review
by the FDA for safety evaluation and eventual marketing in the United States and around the world. Determinations of the safety and efficacy
of our devices in the United States are solely within the authority of the FDA.
A new pre-submission document in preparation of
a new 510(k) and/or De Novo application for our Gen-3 HALO headset at 15 milliamps was filed with the FDA in January of 2023. Formal comments
to our pre-submission document filing were received in March of 2023. A formal meeting to address FDA comments took place on May 9,
2023.
A
second FDA pre-submission document was submitted on February 13, 2024. FDA comments to this second pre-submission document were
received on April 26, 2024. A formal teleconference was held with the FDA on April 30, 2024. The Nexalin regulatory team and
the FDA came to a consensus on the Anxiety and Insomnia Clinical research protocols.
On
May 31, 2023, the Company formalized an agreement related to the formation of a joint venture established to engage in the clinical
development, marketing, sale and distribution of Nexilin’s second generation transcranial Alternating Current Stimulation (“tACS”)
devices (“Gen-2 devices”) in China and other countries in the region. The Joint Venture is registered in Hong Kong.
Under
the Joint Venture Agreement, Wider Come Limited (“Wider”), a related party, is obligated to fund all operations for the
initial 12-month period of the Joint Venture, after which Nexalin and Wider plan to jointly fund the Joint Venture’s operating
expenses in accordance with their pro rata ownership. The Joint Venture conducts research, development and clinical studies of our
devices, which supplements similar activities being conducted by Nexalin in the United States. The Joint Venture is responsible for
funding all clinical trial and development costs incurred in China. We share associated economic responsibility for these expenses
under the terms of the Joint Venture Agreement. The Joint Venture may provide the financial resources for, and– together with
our clinical studies conducted in the U.S. - serve as an important regulatory precursor towards the advancement of our efforts in
securing 510(k) and/or De Novo clearance from the FDA for our devices.
As
of the date of this Quarterly Report on Form 10-Q, we have no employees or office in China and none of our operations are conducted
in China. The Joint Venture does not maintain any variable interest entity structure or operate any data center in China.
The
Joint Venture is controlled by a Board of Directors in which Wider is to have sole representation but neither the Company nor Wider has
exclusive decision-making ability over day-to-day or significant operational decisions. Wider and Nexalin own 52% and 48% of the Joint
Venture, respectively. In accordance with ASC 323 Investments - Equity Method and Joint Ventures (“ASC 323”) and ASC 810
- Consolidations (“ASC 810”), the Company recognized $159 and $0 for the three months ended September 30, 2024 and 2023
and $4,651 and $0 for the nine months ended September 30, 2024 and 2023 of equity method investment income from the Joint Venture
on a one-quarter reporting lag, on the condensed consolidated statements of operations and comprehensive loss.
The
investment in the Joint Venture is accounted for using the equity method of accounting. As of September 30, 2024 and December 31,
2023 the Company had an Equity Method Investment of $100,651 and $96,000, respectively, recorded on the condensed consolidated balance
sheets. The Company invested $96,000 in the joint venture in September 2023 which is recorded on the consolidated balance sheet
at December 31, 2023 as an Equity Method Investment. Wider invested $104,000. In accordance with ASC 323, the Company uses the equity
method of accounting for its investment in the Joint Venture, an unconsolidated entity over which it does not have a controlling interest.
The equity method of accounting requires the investment to be initially recorded at cost and subsequently adjusted for the Company’s
share of equity in the unconsolidated entity’s earnings or losses. The Company evaluates the carrying amount of this investment
in the Joint Venture for impairment in accordance with ASC 323. If the Company determines that a loss in the value of the investment
is other than temporary, the Company writes down the investment to its estimated fair value. Any such losses are recorded to equity in
income of unconsolidated entities in the Company’s consolidated statements of operations and comprehensive loss. The Company has
made an election to classify distributions received from the Joint Venture using the nature of the distribution approach. Distributions
received are classified as cash inflows from operating activities based on the nature of the activities of the unconsolidated entity.
Continued
Nasdaq Listing
Our
common stock is currently listed on The Nasdaq Stock Market. In order to maintain that listing, we must satisfy minimum financial and
other continued listing requirements and standards, including the Minimum Bid Price Rule and Minimum Stockholder Equity Rule (each as
discussed below) and those regarding director independence and independent committee requirements, minimum stockholders’ equity,
and certain corporate governance requirements. There can be no assurances that we will be able to comply with the applicable listing
standards.
We
are required to maintain a minimum bid price of $1.00 per share. On May 10, 2023, the Company received written notice from The Nasdaq
Stock Market LLC (“Nasdaq”) notifying the Company that it was no longer in compliance with the minimum bid price requirement
for continued listing on Nasdaq, as the closing bid price for the Company’s common stock was below $1.00 per share as set forth
in the Nasdaq listing rules. The Company was afforded 180 calendar days, or until November 6, 2023, to regain compliance with the
Nasdaq listing rules. The Company was unable to regain compliance with the bid price requirement by November 6, 2023.
The
Company requested a second 180-day period in order to regain compliance with Nasdaq Rule 5550(a)(2). On January 18, 2024, the
Nasdaq Hearing Panel granted the Company a temporary exception to regain compliance with the Minimum Bid Price Rule until March 27,
2024, which date was further extended by the Panel until April 25, 2024.
On
April 23, 2024, the Company received notice from Nasdaq notifying the Company that it has regained compliance with Nasdaq’s
minimum bid price requirement under Nasdaq Rule 5550(a)(2).
Under
the Nasdaq listing rules, we are also required to maintain stockholders’ equity of at least $2,500,000 (the “Minimum Stockholder
Equity Rule”). In our Form 10-Q for the period ending March 31, 2024, we reported stockholders’ equity of $2,326,987.
On May 16, 2024, we received a letter from the Listing Qualifications Department of Nasdaq notifying the Company that its stockholders’
equity as reported in such Quarterly Report did not satisfy the continued listing requirement under Nasdaq Listing Rule 5550(b)(1)
for the Nasdaq Capital Market.
Pursuant
to the Notice, the Company had 45 calendar days from the date of the Notice to submit a plan to regain compliance. On July 1, 2024,
the Company submitted a plan to Nasdaq. As described in the Company’s submission to Nasdaq, and as set forth in
the Current Report on Form 8-K filed by the Company on July 3, 2024, the Company consummated the public offering of
3 million shares of the Company’s Common Stock for total aggregate gross proceeds of approximately $5,250,000 On July 23,
2024, the Company received written notification from the Listing Qualifications Department of Nasdaq, confirming that, based on the information
contained in the Company’s Form 8-K, filed with the SEC on July 16, 2024, the Company is now in compliance with the Minimum
Stockholder Equity Rule.
On
September 23, 2024, we received a notice from Nasdaq notifying us that we were not in compliance with the Minimum Bid Price Rule.
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we had 180 calendar days, or until March 24, 2025, to regain compliance
with Nasdaq Listing Rule 5450(a)(1). To regain compliance, the closing bid price of our common stock must be at least $1.00 per
share for a minimum of 10 consecutive business days. On October 31, 2024, the Company received notice from Nasdaq notifying the
Company that it has regained compliance with Nasdaq’s minimum bid price requirement under Nasdaq Rule 5550(a)(2).
NOTE
2 — LIQUIDITY
The
accompanying unaudited condensed consolidated financial statements have been prepared on the basis that the Company will continue as
a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. At September 30,
2024, the Company had a significant accumulated deficit of approximately(81,811,956) $81.8 million. For the nine months ended September 30,
2024, the Company had a loss from operations of approximately(4,879,250) $4.9 million and negative cash flows from operations of approximately(2,809,914) $2.8
million. While the Company had a working capital surplus as of September 30, 2024 of approximately $4.6 million, the Company’s
operating activities consume most of its cash resources.
The
Company expects to continue to incur operating losses as it executes its development plans, as well as undertaking other potential strategic
and business development initiatives through 2024 and through the twelve months from the date of this report. In addition, the Company
has had and expects to have negative cash flows from operations, at least into the near future. We previously funded these losses primarily
through the sale of equity. These factors, among others, raise substantial
doubt about the ability of the Company to continue as a going concern for a reasonable period.
Our
ability to continue as a going concern will be dependent upon our ability to execute on our business plan, including the ability to generate
revenue from the joint venture and obtain U.S. approval for the sale of our devices in the United States, and, if necessary, our ability
to raise additional capital. Although no assurances can be given as to our ability to deliver on our revenue plans or that unforeseen
expenses may arise, management has evaluated the significance of the conditions as of September 30, 2024 and have concluded that
we will not have sufficient cash and short-term investments to satisfy our anticipated cash requirements for the next twelve months from
the issuance of these financial statements. The accompanying unaudited condensed consolidated financial statements do not include any
adjustments that might be necessary should we be unable to continue as a going concern.
NOTE
3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NEW ACCOUNTING STANDARDS
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with Generally Accepted Accounting
Principles in the United States (“GAAP”). In the opinion of management, such financial information includes all adjustments
(consisting only of normal recurring adjustments) considered necessary for a fair presentation of the Company’s financial position
and the operating results and cash flows. Operating results for the nine months ended September 30, 2024 and 2023 are not necessarily
indicative of the results that may be expected for any other subsequent interim period. Certain information and footnote disclosures
normally included in consolidated financial statements prepared in accordance with GAAP have been omitted pursuant to the rules of the
SEC. These unaudited condensed consolidated financial statements and related notes should be read in conjunction with the Company’s
audited consolidated financial statements for the year ended December 31, 2023.
Principles
of Consolidation
The
unaudited condensed consolidated financial statements include the accounts of Nexalin and its wholly owned subsidiary Neuro-Health. Intercompany
accounts and transactions have been eliminated in consolidation.
Use
of Estimates
The
preparation of the unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates
and assumptions that affect the reported amounts of assets, liabilities, equity-based transactions, revenue and expenses and disclosure
of contingent liabilities at the date of the consolidated financial statements. The Company bases its estimates and assumptions on historical
experience, known or expected trends and various other assumptions that it believes to be reasonable. As future events and their effects
cannot be determined with precision, actual results could differ from these estimates, which may cause the Company’s future results
to be affected.
Revenue
The
Company recognizes revenue when its performance obligations with its customers have been satisfied. At contract inception, the Company
determines if the contract is within the scope of Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts
with Customers, and then evaluates the contract using the following five steps: (1) identify the contract with the customer; (2)
identify the performance obligations; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations;
and (5) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only recognizes revenue to the extent
that it is probable that a significant revenue reversal will not occur in a future period.
The
Company has existing licensing and treatment fee agreements with its customers for the use of the Nexalin Device in their practices.
These agreements generally have terms of one year with automatic renewal if certain requirements are met and amounts due per these agreements
are billed monthly. The Company also sells products related to the provision of services. The Company sells its Devices in China to its
acting distributor and sells products relating to the use of the Devices. The Company has a Royalty Agreement whereby the manufacturer
of the Company’s electrodes will pay a royalty to the Company for a three-year period beginning January 1, 2022. The amount
of the Royalty is equal to 20% of the amount that the manufacturer invoices to the acting distributor for the sale of the electrodes.
Revenue
Streams
The
Company derives revenues from our license agreements by charging a monthly licensing fee for the duration of the agreement. The Company
derives revenues from equipment by selling additional individual electrodes to customers for use with the Nexalin Device. We receive
revenue from the sale in China of our Devices to our distributor and from the sale of products relating to the use of those Devices.
We derive revenue as a royalty fee from the China-based manufacturer for electrodes ordered in connection with our China sales.
Disaggregated
Revenues
Major
Revenue Streams
Revenue
consists of the following by service offering:
Schedule of disaggregation of revenue | |
| | | |
| | |
| |
Three Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Device sales | |
$ | - | | |
$ | - | |
Licensing fee | |
| 16,941 | | |
| 18,664 | |
Equipment | |
| 18,802 | | |
| 5,179 | |
Other | |
| 288 | | |
| 270 | |
Total | |
$ | 36,031 | | |
$ | 24,113 | |
| |
Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Device sales | |
$ | 55,500 | | |
$ | 9,600 | |
Licensing fee | |
| 54,561 | | |
| 62,566 | |
Equipment | |
| 30,423 | | |
| 16,679 | |
Other | |
| 1,058 | | |
| 1,367 | |
Total | |
$ | 141,542 | | |
$ | 90,212 | |
Major
Geographic Locations
| |
Three Months Ended
September 30, | |
| |
2024 | | |
2023 | |
U.S. sales | |
$ | 20,664 | | |
$ | 24,113 | |
International sales | |
| 15,367 | | |
| - | |
Total | |
$ | 36,031 | | |
$ | 24,113 | |
| |
Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | |
U.S. sales | |
$ | 65,523 | | |
$ | 80,005 | |
International sales | |
| 76,019 | | |
| 10,207 | |
Total | |
$ | 141,542 | | |
$ | 90,212 | |
Cash
and Cash Equivalents
The
Company considers all highly liquid investments with maturities of three months or less at the time of purchase to be cash equivalents.
Cash and cash equivalents held at financial institutions may at times exceed insured amounts. The Company believes it mitigates such
risk by investing in or through, as well as maintaining cash balances with, with major financial institutions.
Short-Term
Investments
The
appropriate classification of marketable securities is determined at the time of purchase and evaluated as of each reporting balance
sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair value
is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or
liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the
assets or liabilities. Unrealized holding gains and losses for equity securities are recognized in earnings. Unrealized holding gains
and losses for available for sale debt securities are recognized in other comprehensive income (loss.) Realized gains and losses and
interest and dividends earned are included in other income (expense), net. For individual debt securities classified as available-for-sale
securities, the Company determines whether a decline in fair value below the amortized cost basis has resulted from a credit loss or
other factors. If the decline below amortized cost is a result of credit loss or the Company will more likely than not be required to
sell the security before recovery of its amortized cost basis, the Company will recognize an impairment relating to the decline through
an allowance for credit losses. There were no deemed permanent impairments for the three and nine months ended September 30, 2024
and 2023, respectively.
Patents
and Trademarks
Patents
and trademarks are amortized over their useful lives and are reviewed for impairment when warranted by economic conditions. Amortization
expense was $10,666 and $2,105 for the nine months ended September 30, 2024 and 2023, respectively. Amortization expense was $4,211
and $753 for the three months ended September 30, 2024 and 2023, respectively.
The
following table summarizes the gross carrying amount, amortization and the net carrying value at September 30, 2024 and December 31,
2023.
Schedule of patents | |
| | | |
| | | |
| | |
| |
Gross Carrying
Amount | | |
Accumulated
Amortization | | |
Net Carrying
Value | |
September 30,
2024 | |
| | | |
| | | |
| | |
Patents | |
$ | 200,906 | | |
$ | (10,680 | ) | |
$ | 190,226 | |
Trademarks | |
| 62,717 | | |
| (4,001 | ) | |
| 58,716 | |
Total September 30, 2024 | |
$ | 263,623 | | |
$ | (14,681 | ) | |
$ | 248,942 | |
| |
| | | |
| | | |
| | |
December 31,
2023 | |
| | | |
| | | |
| | |
Patents | |
$ | 98,970 | | |
$ | (3,751 | ) | |
$ | 95,219 | |
Trademarks | |
| 10,573 | | |
| (264 | ) | |
| 10,309 | |
Total December 31, 2023 | |
$ | 109,543 | | |
$ | (4,015 | ) | |
$ | 105,528 | |
Income
Taxes
The
Company accounts for income taxes pursuant to the asset and liability method which requires the recognition of deferred income tax assets
and liabilities related to the expected future tax consequences arising from temporary differences between the carrying amounts and tax
bases of assets and liabilities based on enacted statutory tax rates applicable to the periods in which the temporary differences are
expected to reverse. Any effects of changes in income tax rates or laws are included in income tax expense in the period of enactment.
The
Company records valuation allowances against deferred tax assets when it is more likely than not that all or a portion of a deferred
tax asset will not be realized. At September 30, 2024 and December 31, 2023, the Company had a full valuation allowance applied
against its net tax assets.
Fair
Value Measurements
As
defined in ASC 820, Fair Value Measurements and Disclosures, fair value is the price that would be received to sell an asset or
paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company
utilizes market data or assumptions that market participants would use in pricing the asset or liability, including assumptions about
risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market corroborated, or
generally unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy
gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurement) and
the lowest priority to unobservable inputs (level 3 measurement). This fair value measurement framework applies at both initial and subsequent
measurement.
|
● |
Level 1: Quoted prices
are available in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions
for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. |
|
|
|
|
● |
Level 2: Pricing inputs
are other than quoted prices in active markets included in Level 1, which are either directly or indirectly observable as of the
reported date. Level 2 includes those financial instruments that are valued using models or other valuation methodologies. These
models are primarily industry-standard models that consider various assumptions, including quoted forward prices for commodities,
time value, volatility factors and current market and contractual prices for the underlying instruments, as well as other relevant
economic measures. Substantially all of these assumptions are observable in the marketplace throughout the full term of the instrument,
can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. |
|
|
|
|
● |
Level 3: Pricing inputs
include significant inputs that are generally less observable from objective sources. These inputs may be used with internally developed
methodologies that result in management’s best estimate of fair value. The significant unobservable inputs used in the fair
value measurement for nonrecurring fair value measurements of long-lived assets include pricing models, discounted cash flow methodologies
and similar techniques. |
Fair
Value of Financial Instruments
The
carrying value of cash, short-term investments, accounts receivable, inventory, prepaids, accounts payable and accrued expenses, and
other current liabilities approximate their fair values based on the short-term maturity of these instruments. The carrying amount of
the loans payable approximates the estimated fair value for this financial instrument as management believes that such debt and interest
payable on the note approximates the Company’s incremental borrowing rate.
The
following table summarizes the amortized cost, unrealized gain (loss) and the fair value at September 30, 2024 and December 31,
2023.
Schedule of unrealized loss on investments | |
| | | |
| | | |
| | |
| |
Amortized Cost | | |
Unrealized Gain
(Loss) | | |
Fair Value | |
September 30, 2024 | |
| | | |
| | | |
| | |
Short-term investments | |
$ | 4,512,522 | | |
$ | (325 | ) | |
$ | 4,512,197 | |
Total September 30, 2024 | |
$ | 4,512,522 | | |
$ | (325 | ) | |
$ | 4,512,197 | |
| |
| | | |
| | | |
| | |
December 31, 2023 | |
| | | |
| | | |
| | |
Short-term investments | |
$ | 2,368,608 | | |
$ | (405 | ) | |
$ | 2,368,203 | |
Total December 31, 2023 | |
$ | 2,368,608 | | |
$ | (405 | ) | |
$ | 2,368,203 | |
The
following table provides the carrying value and fair value of the Company’s financial assets measured at fair value as of September 30,
2024 and December 31, 2023.
Schedule of fair value, assets measured on recurring basis | |
| | | |
| | | |
| | | |
| | |
| |
Carrying Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
September 30, 2024 | |
| | | |
| | | |
| | | |
| | |
U.S. Treasury Notes | |
$ | 4,512,197 | | |
$ | 4,512,197 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
December 31, 2023 | |
| | | |
| | | |
| | | |
| | |
U.S. Treasury Notes | |
$ | 2,368,203 | | |
$ | 2,368,203 | | |
$ | - | | |
$ | - | |
As
defined in ASC 820, Fair Value Measurements and Disclosures, fair value is the price that would be received to sell an asset or paid
to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company utilizes
market data or assumptions that market participants would use in pricing the asset or liability, including assumptions about risk and
the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market corroborated, or generally
unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives
the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurement) and the
lowest priority to unobservable inputs (level 3 measurement). This fair value measurement framework applies at both initial and subsequent
measurement for the three months ended September 30, 2024 and 2023.
Net
Loss per Common Share
The
following table summarizes the securities that would be excluded from the diluted per share calculation because the effect of including
these potential shares was antidilutive due to the Company’s net loss position even though the exercise price could be less than
the most recent fair value of the common shares:
Schedule of antidilutive shares | |
| | | |
| | |
| |
Three Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 2,662,250 | | |
| 2,662,250 | |
Stock options | |
| 2,863,129 | | |
| - | |
Total | |
| 5,525,379 | | |
| 2,662,250 | |
| |
Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 2,662,250 | | |
| 2,662,250 | |
Stock options | |
| 2,863,129 | | |
| - | |
Total | |
| 5,525,379 | | |
| 2,662,250 | |
Stock-Based
Compensation
The
Company applies the provisions of ASC 718, Compensation — Stock Compensation (“ASC 718”), which requires the
measurement and recognition of compensation expense for all stock-based awards made to employees, including employee stock options, in
the condensed consolidated statements of operations and comprehensive loss.
For
stock options issued to employees and members of the board of directors for their services, the Company estimates the grant date fair
value of each option using the Black-Scholes option pricing model. The use of the Black-Scholes option pricing model requires management
to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the
expected life of the option, risk-free interest rates and expected dividend yields of the common stock. For awards subject to service-based
vesting conditions, including those with a graded vesting schedule, the Company recognizes stock-based compensation expense equal to
the grant date fair value of stock options on a straight-line basis over the requisite service period, which is generally the vesting
term. Forfeitures are recorded as they are incurred as opposed to being estimated at the time of grant and revised.
Pursuant
to ASU 2018-07 Compensation — Stock Compensation (Topic 718): Improvements to Non-employee Share-Based Payment Accounting, the
Company accounts for stock options and restricted shares issued to non-employees for their services in accordance with ASC 718. The Company
uses valuation methods and assumptions to value the stock options that are in line with the process for valuing employee stock options
noted above.
Research
and Development
Research
and development costs are charged to operations as incurred. For the nine months ended September 30, 2024 and 2023, the Company
recorded $453,643 and $1,842,341, respectively, in selling, general and administrative expenses on the unaudited condensed consolidated
statements of operations and comprehensive loss. For the three months ended September 30, 2024 and 2023, the Company recorded $178,565
and $1,638,508, respectively, in selling, general and administrative expenses on the unaudited condensed consolidated statements of operations
and comprehensive loss.
Recent
Accounting Pronouncements
In
August of 2023, the FASB issued ASU 2023-05, Business Combinations—Joint Venture (“JV”) Formations: Recognition and
Initial Measurement. The guidance requires newly formed JVs to apply a new basis of accounting to all of its contributed net assets,
which results in the JV initially measuring its contributed net assets under ASC 805-20, Business Combinations. The new guidance would
be applied prospectively and is effective for all newly formed joint venture entities with a formation date on or after January 1,
2025, with early adoption permitted. The Company is evaluating the accounting and disclosure requirements of this update and does not
expect them to have a material effect on the consolidated financial statements.
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The
ASU expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided
to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description
of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. All disclosure
requirements under ASU 2023-07 are also required for public entities with a single reportable segment. The ASU is effective on a retrospective
basis for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15,
2024. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures.
In
December of 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, establishes incremental
disaggregation of income tax disclosures pertaining to the effective tax rate reconciliation and income taxes paid. This standard is
effective for fiscal years beginning after December 15, 2024, and requires prospective application with the option to apply it retrospectively.
Early adoption is permitted. The Company is currently evaluating the potential impact of adopting this standard on our disclosures.
All
other newly issued but not yet effective accounting pronouncements have been deemed to be not applicable or immaterial to the Company.
NOTE
4 — ACCRUED EXPENSES
Accrued
expenses consist of the following amounts:
Schedule of accrued expenses | |
| | | |
| | |
| |
September 30,
2024 | | |
December 31,
2023 | |
Accrued – other | |
| 43,517 | | |
| 21,954 | |
Accrued settlement liabilities | |
| 89,330 | | |
| 89,330 | |
Accrued bonuses | |
| - | | |
| 150,000 | |
| |
$ | 132,847 | | |
$ | 261,284 | |
NOTE
5 — RELATED PARTY TRANSACTIONS
U.S.
Asian Consulting Group, LLC
On
May 9, 2018, the Company entered into a five-year consulting agreement with U.S. Asian Consulting Group, LLC (“U.S. Asian”).
The consulting agreement was extended for an additional period of eight years upon the closing of our initial public offering. The agreement
was amended effective as of July 1, 2024 to expand the services. The two members of U.S. Asian are shareholders in the Company including
Marilyn Elson who is Nexalin’s Controller.
Pursuant
to the consulting agreement, U.S. Asian provides consulting services to the Company with regard to, among other things, corporate development,
financing arrangements and international operations. The Company was paying U.S. Asian $10,000 per month for services
rendered pursuant to the consulting agreement. The amended agreement calls for a monthly fee of $16,667, a onetime stock grant and a semi-annual
share award equal to $100,000 with the issuance and delivery of shares to take place following the termination of the consulting agreement.
The Company recorded consulting expenses related to the consulting agreement of $110,000 and stock compensation expense of $146,000 for
the nine months ended September 30, 2024 and $90,000 of consulting expenses for the nine months ended September 30, 2023, respectively.
The Company recorded $30,000 related to the consulting agreement for each of the three months ended September 30, 2024 and 2023,
respectively, on the Company’s unaudited condensed consolidated statements of operations and comprehensive loss.
Leonard
Osser was issued 200,000
shares of Company stock as compensation for his services on the Advisory Board. The Company recorded $144,000
and $0
of stock compensation expense for the nine months ended September 30, 2024 and September 30, 2023 respectively.
Officers
On
July 1, 2023, the Company entered into a new employment agreement with Mark White to serve as Chief Executive Officer, a new services
agreement with David Owens, M.D. to serve as Chief Medical Officer and a new employment agreement with Michael Nketiah to serve as Senior
Vice President, Quality, Regulatory and Clinical Affairs. Each of the foregoing agreements are governed by three-year terms and provide
compensation in the form of performance-and service-based stock option awards based on the closing price of the Company’s publicly
traded common stock on the applicable date of grant. On July 29, 2024, Michael Nketiah submitted his resignation effective August 16,
2024.
Effective
September 16, 2024, the Company entered into an agreement with Ms. Carolyn Shelton to serve as Senior Vice President, Quality, Regulatory
and Clinical Affairs.
Under
the terms of his employment agreement, Mr. White is entitled to (i) a sign-on/retention bonus consisting of a one-time lump-sum payment
of $50,000 and a grant of nonqualified stock options to purchase 1,387,024 shares of the Company’s common stock with an exercise
price of $.894 per share subject to certain time and performance-based vesting conditions.
Under
the terms of his service agreement, Dr. Owens is entitled to (i) a sign-on/retention bonus consisting of a grant of nonqualified stock
options to purchase 654,362 shares of the Company’s common stock with an exercise price of $.894 per share subject to certain time
and performance-based vesting conditions.
Under
the terms of his employment agreement Mr. Nketiah was entitled to nonqualified stock option grants to purchase 100,671 shares of the
Company’s common stock with an exercise price of $.894 subject to certain time and performance-based vesting conditions.
Under
the terms of her agreement Ms. Shelton is entitled to nonqualified stock option grants to purchase 90,620 shares of the
Company’s common stock with an exercise price of $.6621, subject to certain time and performance-based vesting conditions.
Such options were not granted as of September 30, 2024.
In
addition to the retention payments, stock awards and nonqualified option grants described above, Messrs. White and Nketiah are receiving
cash compensation and each of Messrs. White and Nketiah are eligible for performance-based cash bonuses. The 2023 performance-based milestones
regarding Mr. White’s incentive compensation have been met for 2023, and he was awarded a cash bonus of $120,000 and 313,199 nonqualified
stock options with a vesting date of July 1, 2024. The 2023 performance-based milestones regarding Mr. Nketiah’s incentive
compensation have been met for 2023, and he was awarded a cash bonus of $50,000 and 33,557 nonqualified stock options with a vesting
date of July 1, 2024.
The
reported amounts are calculated in accordance with the provisions of Financial Accounting Standards Board (“FASB”) Accounting
Standard Codification Topic 718, “Compensation — Stock Compensation (“ASC 718”). ASC 718 focuses primarily on
accounting for transactions in which an entity obtains employee services in share-based payment transactions, such as the options issued
under our 2023 Plan.
Leases
Our
principal executive office is located at 1776 Yorktown, Suite 550, Houston, Texas 77056. Under ASC 842 “Leases”, we
have two separate sub-leases (through IIcom Strategic Inc. controlled and owned by our Chief Executive Officer) totalling approximately
4,000 square feet of office space under operating leases. Management and supporting staff are hosted at this location. Our lease costs
for each of the three months ended September 30, 2024 and 2023 were $13,500 and $13,500. Our lease costs for each of the nine months
ended September 30, 2024 and 2023 were $40,500 and $40,500. The initial sub-leases expired in January of 2024. The Company has entered
into a new one year sublease for 4,000 square feet of office space under an operating lease. Pursuant to the sublease, the Company pays
and will pay the third party landlord (not the sub landlord) all direct and indirect rent costs under the primary lease directly for
the leased premises. No additional payments are made to the Chief Executive Officer or the entity controlled by him.
NOTE
6 — STOCKHOLDERS’ EQUITY
Issuance
of Common Stock
During
the nine months ended September 30, 2024, the Company issued an aggregate of 5,425,043 shares of its common stock, as follows:
| ● | 150,000
shares of common stock were issued to affiliates of Wider in satisfaction of obligations
pursuant to their collaborative agreement. A charge to research and development of $750,000
was recorded in 2023 at the time the Company recognized its obligation to issue these shares. |
| ● | 3,000,000
shares of common stock were issued to investors for net proceeds of $4,516,184. |
| ● | 2,275,043
shares of common stock were issued for services in lieu of cash of which 1,232,357 were issued
to outside consultants, 200,000 to a related party, 542,500 to certain employees
of the Company, and 300,186 to current and former members of the Board of Directors for their
services as Board Members. |
During
the nine months ended September 30, 2023, the Company issued 150,000 shares of its common stock to Wider pursuant to their collaborative
agreement resulting in a charge to research and development of $750,000.
Options
Nexalin’s
2023 Equity Incentive Plan (the “2023 Plan”) was approved by our stockholders on November 10, 2023 and an amendment
thereto, increasing the number of shares reserved for issuance under the 2023 Plan, was approved by our stockholders on August 26,
2024. The 2023 Plan provides that maximum number of shares of Common Stock available for the grant of awards thereunder shall be 6,000,000,
subject to adjustment for stock dividends, stock splits or similar events. The 2023 Plan is administered by the Board of Directors, which
may in turn delegate administrative authority to one or more of our executive officers. Under the terms of the 2023 Plan, the Compensation
Committee may grant equity awards, including nonqualified stock options and restricted stock to employees, officers, directors, consultants,
agents, advisors and independent contractors.
On
July 1, 2023, the Company entered into amended employment agreements with the three executives. In addition to the cash compensation
included in their employment contracts, the three executives were granted one-time bonus stock options (that were immediately vested)
and performance-based stock options that would be triggered based on certain performance criteria being achieved. The amount expensed
during the three months ended September 30, 2024 and 2023 in the unaudited condensed consolidated statements of operations and comprehensive
loss was $0 and $0 respectively. The amount expensed during the nine months ended September 30, 2024 and 2023 in the unaudited condensed
consolidated statements of operations and comprehensive loss was $88,120 and $0 respectively.
Certain
employees and certain members of the Board of Directors were issued options to purchase an aggregate of 581,250 shares of common stock.
The options vested immediately upon grant. The amount expensed during the three months ended September 30, 2024 and 2023 in the
unaudited condensed consolidated statements of operations and comprehensive loss was $434,194 and $0 respectively. The amount expensed
during the nine months ended September 30, 2024 and 2023 in the unaudited condensed consolidated statements of operations
and comprehensive loss was $434,194 and $0 respectively.
The
following table presents a summary of stock option award activity during the nine months ended September 30, 2024:
Schedule of stock option award activity | |
| | | |
| | | |
| | |
| |
Number of
options | | |
Weighted
Average
Exercise Price | | |
Weighted
Average
Remaining
Life In Years | |
Outstanding December 31, 2023 | |
| 2,281,879 | | |
$ | 0.89 | | |
| 8.75 | |
Issued | |
| 581,250 | | |
| 0.94 | | |
| 5.00 | |
Exercised | |
| - | | |
| - | | |
| - | |
Expired or cancelled | |
| - | | |
| - | | |
| - | |
Outstanding September 30, 2024 | |
| 2,863,129 | | |
$ | 0.90 | | |
| 8.27 | |
The
following table provides additional information about stock options that are outstanding and exercisable at September 30, 2024:
| Schedule of additional information about stock options | | |
| | | |
| | | |
| | |
Exercise Price | | |
Outstanding Number of Options | | |
Weighted Average Remaining Life In Years | | |
Exercisable Number of Options | |
$ | 0.89 | | |
| 2,281,879 | | |
$ | 8.75 | | |
| 1,152,125 | |
$ | 0.94 | | |
| 581,250 | | |
| 5.00 | | |
| 581,250 | |
| | | |
| 2,863,129 | | |
$ | 8.27 | | |
| 1,733,375 | |
The
fair value of these stock option awards is estimated as of the grant date using a Black-Scholes option pricing model and the following
assumptions: A risk-free interest rate based on the U.S. Treasury yield curve at the date of grant; an expected or contractual term;
and expected volatility based on an evaluation of comparable public companies’ measures of volatility. The Company does not anticipate
declaring dividends on common shares now or in the near future and has therefore assumed no dividend rate. The following tables disclose
the assumptions, utilized for stock options as follows:
For
the 581,250 stock options granted during the nine months ended September 30, 2024, we used the following weighted average assumptions
to estimate the fair value of stock options:
Schedule of assumptions | |
| | |
| |
September 30,
2024 | |
Volatility | |
| 103.8 | % |
Expected dividends | |
$ | - | |
Risk-free interest rate | |
| 3.66 | % |
Expected term (years) | |
| 5.0 | |
For
the stock options outstanding as of December 31,2023, we used the following weighted average assumptions to estimate the fair value
of stock options:
| |
December 31, 2023 | |
Volatility | |
| 99.0 | % |
Expected dividends | |
$ | - | |
Risk-free interest rate | |
| 4.61 | % |
Expected term (years) | |
| 9.5 | |
Warrants
The
issuance of warrants to purchase shares of the Company’s common stock are summarized as follows:
Schedule of warrants | |
| | | |
| | |
| |
Number of
warrants | | |
Weighted
Average
Exercise Price | |
Outstanding December 31, 2023 | |
| 2,662,250 | | |
$ | 4.15 | |
Issued | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | |
Expired or cancelled | |
| - | | |
| - | |
Outstanding September 30, 2024 | |
| 2,662,250 | | |
$ | 4.15 | |
The
following table summarizes information about warrants to purchase shares of the Company’s common stock outstanding and exercisable
at September 30, 2024:
| Summary information about warrants to purchase | | |
| | | |
| | | |
| | | |
| | |
Exercise Price | | |
Outstanding Number of Warrants | | |
Weighted Average Remaining Life In Years | | |
Weighted Average Exercise Price | | |
Exercisable Number of Warrants | |
$ | 4.15 | | |
| 2,315,000 | | |
| 1.00 | | |
$ | 4.15 | | |
| 2,135,000 | |
$ | 4.15 | | |
| 347,250 | | |
| 1.00 | | |
| 4.15 | | |
| 347,250 | |
| | | |
| 2,662,250 | | |
| 1.00 | | |
$ | 4.15 | | |
| 2,662,250 | |
The
compensation expense attributed to the issuance of the warrants, if required to be recognized on the nature of the transaction, was recognized
as they vested/earned. These warrants are exercisable up to three years from the date of grant. All are currently exercisable.
NOTE
7 — COMMITMENTS AND CONTINGENCIES
There
are no material pending legal proceedings in which the Company or any of its subsidiaries is a party or in which any director, officer
or affiliate of the Company, any owner of record or beneficially of more than 5% of any class of its voting securities, or security holder
is a party adverse to us or has a material interest adverse to the Company other than the following:
Sarah
Veltz v. Nexalin Technology, Inc. et al.
Plaintiff,
Sarah Veltz, filed a lawsuit in this matter on January 20, 2021 in Orange County Superior Court (Case No. 30-2021-01180164-CU-WT-CJC)
(the “Complaint”) naming the Company and others as defendants. In her Complaint, Plaintiff contends that she was employed
by defendants, including Nexalin, and has not been paid all wages, including overtime wages and other benefits allegedly due her. Plaintiff
also contends that, during her employment, she was subjected to sexual harassment by the Company’s then Chief Executive Officer.
Plaintiff seeks both compensatory and punitive damages. On March 12, 2021, the Company filed its answer to the Complaint. Although
the parties are seeking mediation, the court has set a trial in this matter for June 9, 2025, with a mediation date not yet set.
Management’s intent is to contest the allegations vigorously and, as of the date of this report, is unable to provide an evaluation
of the potential outcome of the litigation within the probable or remote range or to provide an estimate of the amount of or a range
of potential loss that might be incurred by the Company.
Employment
Development Department
The
Company is currently engaged in settlement discussions with the Employment Development Department (EDD) of the State of California. This
matter involves issues related to our previous management’s classification of certain work provided to or on behalf of the Company’s
business as contract labor instead of employee labor. The total amount involved was approximately $300,000. Management has petitioned
for reassessment and believes the hired workers at issue were indeed actual contractors and not employees. We have no business in California
other than one part time and one full time worker residing in California. The EDD approved a significant downward adjustment in our outstanding
employment tax liability to approximately $40,000 as reflected on its Statement of Account dated November 30, 2023. We plan to further
negotiate with the EDD and proceed with a settlement offer. The Company has accrued $40,000 and $40,000 on the consolidated balance sheets
as of September 30, 2024 and December 31, 2023, respectively. The reduction in the amount accrued was recognized as other income
on the consolidated statement of operations and comprehensive loss for the year ended December 31, 2023. The Company believes it
has adequately accrued for this matter.
Demand
Letter from The University of Arizona
On
December 8, 2022, the Company received a demand letter from the University of Arizona seeking payment of $111,094. The Company and
the University of Arizona agreed on the terms of a settlement for the amounts claimed by the University, whereby the Company paid an
aggregate of approximately $69,000 (in three equal monthly payments) in full satisfaction of amounts the University claims it is owed.
The settlement amount was paid in full as of December 31, 2023.
NOTE
8 — CONCENTRATION OF CREDIT RISK
Revenues
Five
customers accounted for 75% of revenues for the three months ended September 30, 2024 and two customers accounted for 59% of revenues
for the nine months ended September 30, 2024, as set forth below:
Concentration of credit risk | |
| | | |
| | |
| |
Three Months Ended September 30,
2024 | | |
Nine Months Ended September 30,
2024 | |
Customer A | |
| 23 | % | |
| 48 | % |
Customer B | |
| 18 | % | |
| 11 | % |
Customer C | |
| 13 | % | |
| - | |
Customer D | |
| 11 | % | |
| - | |
Customer E | |
| 10 | % | |
| - | |
Three
customers accounted for 70% and 55% of revenues for the three and nine months ended September 30, 2023, respectively as set forth
below:
| |
Three Months Ended September 30,
2023 | | |
Nine Months Ended September 30,
2023 | |
Customer A | |
| 27 | % | |
| 24 | % |
Customer B | |
| 23 | % | |
| 18 | % |
Customer C | |
| 20 | % | |
| 13 | % |
Accounts
Receivable
Four
customers accounted for 78% of accounts receivable at September 30, 2024, as set forth below:
Customer A | |
| 43 | % |
Customer B | |
| 18 | % |
Customer C | |
| 17 | % |
Five
customers accounted for 97% of accounts receivable at December 31, 2023.
Customer A - related party | |
| 39 | % |
Customer B | |
| 21 | % |
Customer C | |
| 15 | % |
Customer D | |
| 12 | % |
Customer E | |
| 10 | % |
NOTE
9 — SUBSEQUENT EVENTS
On November
7, 2024, the Company entered into stock option agreements with two employees for services in lieu of cash, and two members of the Board
of Directors for their services as Board Members, granting options to purchase an aggregate of 581,250 shares of the Company’s common
stock at an exercise price of $.94 per share. Such stock options were immediately vested.
On November 7, 2024, the Company
entered into a stock option agreement with Michael Nketiah with respect to his July 1, 2023 Employment Agreement. Mr. Nketiah was granted
performance-based stock options to purchase 100,671 shares of common stock at an exercise price of $.894 per share.
On
November 7, 2024, the Company entered into a stock option agreement with Carolyn Shelton. Ms. Shelton was granted performance-based
stock options to purchase up to 90,620
shares of common stock at an exercise price of $.6621
per share that would be triggered based on certain performance criteria being achieved. Such options vest in three equal
portions over the three year period beginning on the first anniversary of her employment date.
On October
28, 2024, the Board of Directors approved the issuance of an aggregate of 363,635 shares of our restricted common stock for services
in lieu of cash, to outside consultants and to Wider, a related party.
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
You
should read the following discussion and analysis of our financial condition and results of operations together with our financial statements
and related notes appearing in this Quarterly Report. Some of the information contained in this discussion and analysis or set forth
elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking
statements that involve risks and uncertainties. As a result of many factors, our actual results could differ materially from the results
described in or implied by the forward-looking statements contained in the following discussion and analysis. Forward-looking statements
represent our management’s beliefs and assumptions only as of the date of this Quarterly Report. Actual future results may be materially
different from what we expect. We undertake no obligation to update such statements to reflect events that occur or circumstances that
exist after the date on which they are made, except as required by applicable law.
The
management’s discussion and analysis of our financial condition and results of operations are based upon our unaudited financial
statements, which have been prepared in accordance with GAAP.
Overview
We
design and develop innovative neurostimulation products to uniquely and effectively help combat the ongoing global mental health epidemic.
We developed an easy-to-administer medical device — referred to as Generation 1 or Gen-1 — that utilizes bioelectronic medical
technology to treat anxiety and insomnia, without the need for drugs or psychotherapy. Our original Gen-1 devices are cranial electrotherapy
stimulation (CES) devices that emit waveform at 4 milliamps during treatment and are presently classified by the U.S. Food and Drug Administration
(“FDA”) as a Class II device.
Medical
professionals in the United States have utilized the Gen-1 device to administer to patients in clinical settings. While the Gen-1 device
had been cleared by the FDA to treat depression, anxiety, and insomnia, three prevalent and serious diseases, because of the FDA’s
December 2019 reclassification of CES devices, the Gen-1 device was reclassified as a Class II device for the treatment of anxiety
and insomnia. We are required to file a new application under Section 510(k) of the Federal Food, Drug and Cosmetic Act (“510(k)
Application”) to be approved by the FDA for the sales and marketing of our devices for the treatment of anxiety and insomnia. In
the FDA’s December 2019 reclassification ruling, the treatment of depression with our device will require a Class III certification
and require a new PMA (premarket approval) application to demonstrate safety and effectiveness.
While
we continue providing services to medical professionals to support patients’ use of the Gen-1 devices which were in operation prior
to December 2019, we are not making new sales or new marketing efforts of Gen-1 devices in the United States. We continue to derive
revenue from devices which we sold or leased prior to the FDA’s December 2019 reclassification announcements. This revenue
consists of monthly licensing fees and payments for the sale of electrodes and patient cables. We have suspended marketing efforts for
new sales of devices related to the Gen-1 device for treatment of anxiety and insomnia in the United States until the Nexalin regulatory
team decides on a new 510(k) application at 4 milliamps based on FDA comments expected to be received in 2024. Our regulatory team continues
to inform the FDA of the suspension of the marketing and sale of the Gen-1 products to new providers. We are currently analyzing whether
to proceed with an amended application with the FDA for Gen-1 devices for the treatment of insomnia and anxiety.
We have designed and developed a new advanced
waveform technology to be emitted at 15 milliamps through new and improved medical devices referred to as “Generation 2”
or “Gen-2” and “Generation 3” or “Gen-3.” Gen-2 is a clinical use device with a modern enclosure
to emit the new 15 milliamp advanced waveform. Gen-3 is a new patient headset that is designed to be prescribed by licensed medical professionals
in a virtual clinic setting similar to existing Tele-health platforms. The Nexalin research team believes that the new 15 milliamp Gen-2
and Gen-3 devices can penetrate deeper into the brain and stimulate associated structures of mental illness, which we believe will generate
enhanced patient response without any risk or unpleasant side effects. The Nexalin regulatory team has made a strategic decision to develop
strategies for pilot trials and/or pivotal trials in various mental health disease states. In addition, a new PMA application in the
United States is in development for the treatment of depression utilizing both Gen-2 and Gen-3. The new Gen-3 device is also scheduled
for additional pilot trials and/or pivotal trials for anxiety and insomnia in the United States and China beginning in the fourth quarter
of 2024. Preliminary data provided by The University of California, San Diego and recent published data from China supports the safety
of utilizing our 15 milliamp waveform technology. However, the determination of safety and efficacy of medical devices in the United
States is subject to clearance by the FDA.
Additionally,
a new pre-submission document in preparation of a new 510(k) and/or De Novo for our Gen-3 Halo headset at 15 milliamps was filed with
the FDA in January of 2023. Formal comments to our pre-submission document filing were received in March of 2023. A formal meeting to
address FDA comments took place on May 9, 2023. Minutes of the meeting with the FDA were filed with the FDA on May 16, 2023.
A
second FDA pre-submission document was submitted on February 13, 2024. FDA comments to this second pre-submission document were
received on April 26, 2024. A formal teleconference was held with the FDA on April 30, 2024. The Nexalin regulatory team and
the FDA came to a consensus on the Anxiety and Insomnia Clinical research protocols.
In
part due to the increasing incidence attributed to the devastating impacts of the COVID-19 pandemic, mental health and cognitive
disorders are widespread across the globe and cause substantial health, social and economic losses, and hardships accordingly. Our
focus is on the continued development of our innovative bioelectronic medical technologies and rapid regulatory approval. We intend
to help reverse these losses, and hardships of these losses, by safely and effectively treating various mental health disorders
associated with post Covid and long Covid mental disease states.
All
our products are non-invasive, safe, undetectable to the human body and can provide relief to those afflicted with mental health issues
without adverse side effects. We have a proprietary design that stabilizes currents, electromagnetic fields, and various frequencies
— referred to collectively as a waveform - particularly our proprietary, 15 milliamp patented waveform. Additionally, our devices
generate a high frequency carrier wave for deeper penetration into the brain. It is applied to the brain with an array of electrodes
on the forehead and behind each ear at the mastoid. The features of this proprietary waveform and the array of electrodes allow the application
of the waveform to the entire brain rather than a small, targeted area of the brain. To ensure deeper penetration into the brain, we
have created a waveform that is undetectable to the brain which allows the increase of the power from < 4 mAmps to 15 mAmps, more
than a 400% increase without incurring any patient discomfort, risk, or adverse side effects. By increasing the power, our waveform can
penetrate deeper into the brain and stimulate deep mid-brain structures associated with mental illness. Our research and clinical teams
believe that a more powerful waveform will create a stronger response in the brain. A stronger response creates a higher level of efficacy.
This entire proprietary technique allows Nexalin to provide a non-invasive and comfortable treatment that is more powerful than any stimulation
device in the market. Current pilot study protocols and randomized clinical trials have been designed and submitted to the FDA to provide
feedback on final reports and data sets for the purpose of safety and efficacy evaluations in the future. Determinations of the safety
and efficacy of our devices are solely within the authority of the FDA.
Currently,
the waveform that comprises the basis of Gen-2 and new Gen-3 headset devices has been tested in research settings to develop safety data
that has been submitted for review by the FDA for safety evaluation and eventual marketing in the United States and around the world.
Determinations of the safety and efficacy of our devices in the United States are solely within the authority of the FDA.
We
recognize that an additional barrier to treatment in today’s mental health treatment landscape -- beyond the concerns about safety,
efficacy and side-effects that have been associated with conventional mental health treatments such as ECT (shock therapy), drugs and
psychotherapy – is stigma. We have received industry reports and feedback that many patients that struggle with mood disorders
have the stigma of embarrassment associated with psychiatrists and psychotherapy (e.g., counselling with a therapist). Additional stigmas
and other issues are associated with the side effects of medication prescribed by psychiatrists. When we researched the current pharmaceuticals
model, public information highlighted the many side effects associated with these medications. Frequently, patients would stop taking
the medication because of the uncomfortable side effects. Additional public information mentions dependency and withdrawal issues associated
with medication for psychiatric disorders.
To
address the embarrassment stigma, we are developing a new virtual clinic that will allow the physician to diagnose a mental health issue
in the privacy of a tele-psychiatry virtual platform. After diagnosis, the physician will prescribe the Nexalin Gen-3 headset to the
patient for treatment. Next, the Gen-3 device will be shipped to the patient’s home. After the patient receives the device, they
will pair the headset device with an app in the patient’s smart phone. The app will communicate with the Nexalin cloud servers
to authorize the device for treatment according to the protocol designed by the physician. The physician will monitor treatment compliance
and other health related issues in a private physician dashboard that connects through the Nexalin app and cloud servers. We believe
that to preserve product safety and integrity for home use, the headset device will require physician oversight that will include a prescription
for use with a monthly authorization provided by the physician after a monthly virtual visit. All appointments will be in a virtual setting
to provide privacy and convenience for the physician and patient. The Nexalin virtual clinic will be provided in a proprietary virtual
platform currently in the design stage.
Our
China Gen-2 15 milliamp device was approved in China by the NMPA for the treatment of insomnia and depression in China. This device and
all other clinical devices will include a single use electrode for long term revenue streams. The USA Gen-2 device will have a fresh
and modern appearance that meets the technology standards of the digital tech world of 2024. Early adopters of the Gen-1 device will
be able to access additional firmware upgrades which are planned to enhance the previously purchased devices to the new symmetric15-milliamp
waveform. Our Gen-2 device will be equipped with RFID technology that exchanges electrode usage data with a reader in the main device.
The purpose of RFID is to track and maintain control of the proprietary single use electrode. Our electrode chip will be programmed to
exchange data with the device and allow activation for a single treatment with a new electrode only. This ensures a recurring revenue
stream on the device and protects against any generic knockoffs designed to avoid treatment costs. This upgrade in technology also ensures
the proprietary nature of the electrodes that support treatment outcomes are sustained.
Overall,
we believe that our advanced waveform, technological upgrades and the development of a modern headset monitored with our IT management
platform will position us with the opportunity to disrupt the traditional mental health treatment model. Our mission is to remove the
stigma of expensive psychotherapy or pharmaceuticals with the attendant side effects and dependency issues and replace such stigma with
clinically proven and cost-effective technology that is easily accessible in the privacy of the patient’s home and monitored by
licensed healthcare providers.
Since
our inception, we have generated significant losses; we expect to continue to incur significant expenses and increasing operating losses
for at least the next two years. Our net losses may fluctuate significantly from period to period, depending on the timing of our planned
clinical trials and expenditures for other research and development activities. We expect our expenses will increase substantially over
time as we:
|
● |
continue the ongoing and
planned preclinical and clinical development of our products; |
|
|
|
|
● |
review and analyze the
value of amending our previous 510(k) Application for anxiety and insomnia in accordance with the FDA; |
|
|
|
|
● |
arrange for an outsourced
sales, marketing and distribution model and scale up external manufacturing capabilities to commercialize any product candidate for
which we may obtain regulatory approval and intend to commercialize; |
|
|
|
|
● |
maintain, expand and protect
our intellectual property portfolio; |
|
|
|
|
● |
engage additional clinical,
scientific, manufacturing and controls personnel; |
|
|
|
|
● |
add additional information
systems including personnel to support our product development; |
Furthermore,
we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor
relations and other expenses that we did not incur as a private company.
Recent
Developments
Formalized
Joint Venture; China Related Activities; Approvals in Oman and Brazil
On
May 31, 2023, the Company formalized an agreement related to the formation of a joint venture established to engage in the clinical
development, marketing, sale and distribution of Nexilin’s second generation transcranial Alternating Current Stimulation (“tACS”)
devices (“Gen-2 devices”) in China and other countries in the region. The Joint Venture is registered in Hong Kong.
As
of the date of this Quarterly Report on Form 10-Q, (i) our operations are carried on outside of China; and (ii) the Joint Venture
does not maintain any variable interest entity structure or operate any data center in China.
Under
the Joint Venture Agreement, Wider is obligated to fund all operations for the initial 12-month period of the Joint Venture, after which
Nexalin and Wider plan to jointly fund the Joint Venture’s operating expenses in accordance with their pro rata ownership.
The
Joint Venture is controlled by a Board of Directors in which Wider is to have sole representation but neither the Company nor Wider has
exclusive decision-making ability over day-to-day or significant operational decisions. Wider and Nexalin own 52% and 48% of the Joint
Venture, respectively. In accordance with ASC 323 and ASC 810, the Company recognized $159 and $0 for the three months ended September 30,
2024 and 2023 and $4,651 and $0 of equity method investment income from the Joint Venture on a one-quarter reporting lag for the nine
months ended September 30, 2024 and 2023, respectively, on the condensed consolidated statements of operations and comprehensive
loss.
During
the nine months ended September 30, 2024, the Company issued 150,000 shares of common stock to affiliates of Wider in satisfaction
of obligations pursuant to their collaborative agreement. A charge to research and development was recorded in 2023 at the time the Company
recognized its obligation to issue these shares.
The
investment in the Joint Venture is accounted for using the equity method of accounting. As of September 30, 2024 and December 31,
2023 the Company had an Equity Method Investment of $100,651 and $96,000, respectively, recorded on the condensed consolidated balance
sheets. The Company invested $96,000 in the joint venture in September 2023 and Wider invested $104,000. In accordance with ASC
323, the Company uses the equity method of accounting for its investment in the Joint Venture, an unconsolidated entity over which it
does not have a controlling interest. The equity method of accounting requires the investment to be initially recorded at cost and subsequently
adjusted for the Company’s share of equity in the unconsolidated entity’s earnings or losses. The Company evaluates the carrying
amount of this investment in the Joint Venture for impairment in accordance with ASC 323. If the Company determines that a loss in the
value of the investment is other than temporary, the Company writes down the investment to its estimated fair value. Any such losses
are recorded to equity in income of unconsolidated entities in the Company’s condensed consolidated statements of operations and
comprehensive loss. The Company has made an election to classify distributions received from the Joint Venture using the nature of the
distribution approach. Distributions received are classified as cash inflows from operating activities based on the nature of the activities
of the unconsolidated entity.
In
September of 2021, the China National Medical Products Administration (the “NMPA”), the equivalent of the FDA, approved the
Gen-2 device for marketing and sale in China for the treatment of insomnia and depression. These treatment indications and clearances
from the NMPA have allowed Wider to market and sell the Gen-2 device in China for the treatment of insomnia and depression.
Our
participation in the Joint Venture with Wider in China is subject to general, as well as industry-specific, economic, political and legal
developments and risks in China. The Chinese government exercises significant control over the Chinese economy, including but not limited
to controlling capital investments, allocating resources, setting monetary policy, controlling and monitoring foreign exchange rates,
implementing and overseeing tax regulations, providing preferential treatment to certain industry segments or companies and issuing necessary
licenses to conduct business. In addition, we could face additional risks resulting from changes in China’s data privacy and cybersecurity
requirements. Accordingly, any adverse change in the Chinese economy, the Chinese legal system or Chinese governmental, economic or other
policies could have a material adverse effect on our business and operations of the Joint Venture in China and our prospects generally.
We
face additional risks in China due to China’s historically limited recognition and enforcement of contractual and intellectual
property rights. We may experience difficulty enforcing our intellectual property rights in China. If we cannot adequately monitor the
use of our technologies and devices or enforce intellectual property rights related to our devices in China or contractual restrictions
relating to use of our intellectual property by Chinese companies, our revenue could be adversely affected.
The
Joint Venture with Wider is subject to laws and regulations applicable to foreign investment in China. There are uncertainties regarding
the interpretation and enforcement of laws, regulations and policies in China. Because many of the laws, regulations and policies applicable
to our operations in China are relatively new, the interpretations of such laws, regulations and policies are not always uniform. Moreover,
the interpretation of statutes and regulations may be subject to government policies reflecting domestic political agendas. Enforcement
of existing laws or contracts may be uncertain. As a result of the foregoing, it may be difficult for us to obtain timely or equitable
enforcement of laws ostensibly designed to protect companies like ours, which could have a material adverse effect on our business and
results of operations. Our ability to monetize the Joint Venture in China may also be limited.
The
Sultanate of Oman’s Ministry of Health granted conditional approval for use of our Gen-2 device on June 16, 2022, effective
upon the end user of our device opening and operating a mental health care clinic being constructed in Oman. The Company’s first
shipment of a device to Oman was made on January 30, 2024 and received in Oman on February 5, 2024 in connection with the opening
of the end user’s clinic, rendering the approval effective. Two additional devices were shipped to Oman on February 29, 2024
and were received by the end user on March 6, 2024. Upon receipt of the two additional devices, the end user’s clinic was
operational, and the use of the device to treat patients commenced pursuant to the approval.
On
June 13, 2024, the “Company announced that our Gen-2 device had been granted regulatory approval by the Brazilian Health Regulatory
Agency, a regulatory body of the Brazilian government responsible for approving new drugs and medical devices.
Results
of Operations
Comparison
of the three months ended September 30, 2024 and 2023
Our
financial results for the three months ended September 30, 2024 and 2023 are summarized as follows:
| |
Three Months Ended
September 30, | | |
| | |
| |
| |
2024 | | |
2023 | | |
Change | | |
Change(1) | |
| |
| | |
| | |
$ | | |
% | |
Revenues, net | |
$ | 36,031 | | |
$ | 24,113 | | |
$ | 11,918 | | |
| 49 | % |
Cost of revenues | |
| 12,694 | | |
| 3,973 | | |
| 8,721 | | |
| 220 | % |
Gross profit | |
| 23,337 | | |
| 20,140 | | |
| 3,197 | | |
| 16 | % |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Professional fees | |
| 262,303 | | |
| 127,202 | | |
| 135,101 | | |
| 106 | % |
Salaries and benefits | |
| 294,175 | | |
| 363,330 | | |
| (69,155 | ) | |
| (19 | )% |
Selling, general and administrative | |
| 1,975,376 | | |
| 1,945,145 | | |
| 30,231 | | |
| 2 | % |
Total operating expenses | |
| 2,531,854 | | |
| 2,435,677 | | |
| 96,177 | | |
| 4 | % |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (2,508,517 | ) | |
| (2,415,537 | ) | |
| (92,980 | ) | |
| 4 | % |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense), net: | |
| | | |
| | | |
| | | |
| | |
Interest income (expense), net | |
| 1,000 | | |
| (5,330 | ) | |
| 6,330 | | |
| 119 | % |
Gain on sale of short-term investments | |
| 56,250 | | |
| 82,943 | | |
| (26,693 | ) | |
| (32 | )% |
Other income | |
| 2,851 | | |
| 40,735 | | |
| (37,884 | ) | |
| (93 | )% |
Total other income (expense), net | |
| 60,101 | | |
| 118,348 | | |
| (58,247 | ) | |
| (49 | )% |
| |
| | | |
| | | |
| | | |
| | |
Loss before equity in net earnings of affiliate | |
| (2,448,416 | ) | |
| (2,297,189 | ) | |
| (151,227 | ) | |
| 7 | % |
Equity in net earnings of affiliate | |
| 159 | | |
| - | | |
| 159 | | |
| 100 | % |
Net loss | |
$ | (2,448,257 | ) | |
$ | (2,297,189 | ) | |
$ | (151,068 | ) | |
| 7 | % |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive income (loss): | |
| | | |
| | | |
| | | |
| | |
Unrealized loss from short-term investments | |
| (325 | ) | |
| (32,289 | ) | |
| 31,964 | | |
| 99 | % |
Comprehensive loss | |
$ | (2,448,582 | ) | |
$ | (2,329,478 | ) | |
$ | (119,104 | ) | |
| 5 | % |
| (1) | Percentages may not foot due to rounding. |
Revenues
For
the three months ended September 30, 2024 and 2023, we generated $36,031 and $24,113 respectively, of revenue primarily from the
sale of devices, supplies and from licensing and treatment fee agreements with our customers for which we charge a monthly licensing
fee for the duration of the agreement. We also generated revenue from treatment fee agreements by collecting fees based on the number
of treatments per month the customer performs. In addition, we derived revenue from equipment by selling electrodes and patient cables
to customers for use with our device. The increase in revenue for the three months ended September 30 2024 compared to 2023 was
primarily due to sales of supplies and parts.
Cost
of Revenues and Gross Profit
For
the three months ended September 30, 2024 and 2023, cost of revenues was $12,694 and $3,973, respectively, yielding a gross profit
of $23,337 and $20,140, respectively, or 64.77% and 83.52%, respectively. Such decrease in gross margin was due to the lower margins
on supplies and parts.
Operating
Expenses
Total
operating expenses for the three months ended September 30, 2024 and 2023 were $2,531,854 and $2,435,677, respectively. The increase
in selling, general and administrative expenses was due primarily to an increase in shareholder related expenses of approximately $56,000,
an increase in professional fees of approximately $79,000, an increase in travel of approximately $34,000, and an increase in stock compensation
of approximately $1,466,000. These amounts were offset by a decrease in salaries and benefits of approximately $69,000 a decrease
in research and development costs of approximately $1,452,000 and a decrease in insurance of approximately $17,000.
The
increase in shareholder related expenses was due to costs associated with investor relations. The increase in professional fees is due
to an increase in legal fees and an executive search professional fee of $60,000. The increase in travel is primarily due to costs associated
with meetings with our joint venture partners, staff visits to our Houston office and travel related to investor relations. The increase
in stock compensation is primarily related to compensating consultants with stock compensation upon shareholder approval of amending
the Company Equity Plan. The decrease in salaries is primary due to a bonus recorded in 2023. The decrease in research and development
costs are primarily related to costs associated with clinical trials not incurred in 2024. The decrease in insurance is due to a reduction
in our insurance premiums.
Other
Income (Expense), Net
Other
income (expense), net for the three months ended September 30, 2024 and 2023 was $60,101 and $118,348, respectively, consisting
of interest and dividend income, gain on the sale of short-term investments offset by interest expense. The decrease in other income
was due to a decrease in the amount available for investment.
Comparison
of the nine months ended September 30, 2024 and 2023
Our
financial results for the nine months ended September 30, 2024 and 2023 are summarized as follows:
| |
Nine Months Ended
September 30, | | |
| | |
| |
| |
2024 | | |
2023 | | |
Change | | |
Change(1) | |
| |
| | |
| | |
$ | | |
% | |
Revenues, net | |
$ | 141,542 | | |
$ | 90,212 | | |
$ | 51,330 | | |
| 57 | % |
Cost of revenues | |
| 29,097 | | |
| 20,457 | | |
| 8,640 | | |
| 42 | % |
Gross profit | |
| 112,445 | | |
| 69,755 | | |
| 42,690 | | |
| 61 | % |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Professional fees | |
| 731,099 | | |
| 405,949 | | |
| 325,150 | | |
| 80 | % |
Salaries and benefits | |
| 928,072 | | |
| 965,988 | | |
| (37,916 | ) | |
| (4 | )% |
Selling, general and administrative | |
| 3,332,524 | | |
| 2,769,641 | | |
| 562,883 | | |
| 20 | % |
Total operating expenses | |
| 4,991,695 | | |
| 4,141,578 | | |
| 850,117 | | |
| 21 | % |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (4,879,250 | ) | |
| (4,071,823 | ) | |
| (807,427 | ) | |
| 20 | % |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense), net: | |
| | | |
| | | |
| | | |
| | |
Interest income (expense), net | |
| 1,370 | | |
| (19,685 | ) | |
| 21,055 | | |
| 107 | % |
Gain on sale of short-term investments | |
| 92,915 | | |
| 180,593 | | |
| (87,678 | ) | |
| (49 | )% |
Other income | |
| 6,407 | | |
| 42,875 | | |
| (36,468 | ) | |
| (85 | )% |
Total other income (expense), net | |
| 100,692 | | |
| 203,783 | | |
| (103,091 | ) | |
| (51 | )% |
| |
| | | |
| | | |
| | | |
| | |
Loss before equity in net earnings of affiliate | |
| (4,778,558 | ) | |
| (3,868,040 | ) | |
| (910,518 | ) | |
| 24 | % |
Equity in net earnings of affiliate | |
| 4,651 | | |
| - | | |
| 4,651 | | |
| 100 | % |
Net loss | |
$ | (4,773,907 | ) | |
$ | (3,868,040 | ) | |
$ | (905,867 | ) | |
| 24 | % |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive income (loss): | |
| | | |
| | | |
| | | |
| | |
Unrealized gain (loss) from short-term investments | |
| 80 | | |
| (35,513 | ) | |
| 35,593 | | |
| 100 | % |
Comprehensive loss | |
$ | (4,773,827 | ) | |
$ | (3,903,553 | ) | |
$ | (870,274 | ) | |
| 22 | % |
| (1) | Percentages may not foot due to rounding. |
Revenues
For
the nine months ended September 30, 2024 and 2023, we generated $141,542 and $90,212 respectively, of revenue primarily from the
sale of devices, supplies and from licensing and treatment fee agreements with our customers for which we charge a monthly licensing
fee for the duration of the agreement. We also generated revenue from treatment fee agreements by collecting fees based on the number
of treatments per month the customer performs. In addition, we derived revenue from equipment by selling electrodes and patient cables
to customers for use with our device. The increase in revenue for the nine months ended September 30, 2024 compared to 2023 was
primarily due to the sales of devices to a new overseas customer.
Cost
of Revenues and Gross Profit
For
the nine months ended September 30, 2024 and 2023, cost of revenues was $29,097 and $20,457, respectively, yielding a gross profit
of $112,455 and $69,755, respectively, or 79.44% and 77.32%, respectively. Such increase in gross margin was primarily due to device
revenue having a higher gross profit margin than that of other sources of revenue.
Operating
Expenses
Total
operating expenses for the nine months ended September 30, 2024 and 2023 were $4,991,695 and $4,141,578, respectively. The increase
in selling, general and administrative expenses was due primarily to an increase in shareholder related expenses of approximately $271,000,
an executive search professional fee of $60,000, an increase in travel of approximately $115,000, and an increase
in stock compensation of approximately $1,847,000. These amounts were offset by a decrease in research and development costs of
approximately $1,389,000, a decrease in taxes of approximately $21,000, and a decrease in insurance of approximately $57,000.
The
increase in shareholder related expenses was due to costs associated with investor relations. The increase in stock compensation is primarily
related to compensating consultants with stock compensation upon shareholder approval of amending the Company Equity Plan. The increase
in travel is primarily due to costs associated with meetings with our joint venture partners, staff visits to our Houston office and
travel related to investor relations. The decrease in research and development costs are primarily related to costs associated with clinical
trials not incurred in 2024. The decrease in taxes is due to a reduction in our Delaware Franchise tax. The decrease in insurance is
due to a reduction in our insurance premiums.
Other
Income (Expense), Net
Other
income (expense), net for the nine months ended September 30, 2024 and 2023 was $100,692 and $203,753, respectively, consisting
of interest and dividend income, gain on the sale of short-term investments offset by interest expense. The decrease is primarily due
to a decrease in gain on short term investments resulting from decreased short term investments.
Cash
Flows
The
following table summarizes our consolidated cash flows for the nine months ended September 30, 2024 and 2023:
| |
September 30,
2024 | | |
September 30,
2023 | |
Net cash used in operating activities | |
$ | (2,809,914 | ) | |
$ | (2,831,354 | ) |
Net cash provided by (used in) investing activities | |
$ | (2,205,079 | ) | |
$ | 3,230,008 | |
Net cash provided by (used in) financing activities | |
$ | 4,516,184 | | |
$ | (200,000 | ) |
Net
Cash Used In Operating Activities
Net
cash used in operating activities was $(2,809,914) for the nine months ended September 30, 2024, as compared to $(2,831,554) for
the respective period in 2023, was primarily due to the net loss of $4,773,907, as well as a combined decrease in accrued expenses of
approximately $196,000, offset by increases in stock compensation of approximately $347,000 and accounts payable and accounts payable-related
party of approximately $593,000.
Net
Cash Provided By (Used In) Investing Activities
Net
cash provided by (used in) investing activities during the nine months ended September 30, 2024, and 2023 was $(2,205,079) and $3,230,008,
respectively, which was due to short-term investment sales approximately $22.3 million offset by purchases of approximately $24.4 million
of short-term investments for the nine months ended September 30, 2024. Compared to short-term investment sales of approximately
$32.7 million offset by purchases of $29.3 million of short-term investments during the nine months ended September 30,
2023.
Net
Cash Provided By (Used In) Financing Activities
Net
cash provided by (used in) financing activities during the nine months ended September 30, 2024 and 2023 was $4,516,184 and
$(200,000), respectively, which was due to the issuance of common stock for approximately $4.5 million from the July 1, 2024
offering. The September 30, 2023 use of cash was for a payment of note payable to an officer of the
Company.
Uses
and Availability of Additional Funds
Our
primary uses of capital are, and we expect will continue to be, compensation and related expenses, third-party clinical research and
development services, manufacturing development costs, legal and other regulatory expenses, and general administrative costs. Although
we have produced Gen-2, which is selling in China where it is approved for certain utilizations by medical practitioners, the successful
development of our future products is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and estimated
costs of the efforts that will be necessary to complete the clinical development of Gen-3 and obtain regulatory approvals. We are also
unable to predict when, if ever, net cash inflows from revenues will enable us to be cash flow positive. This is due to the numerous
risks and uncertainties associated with developing products, including, among others, the uncertainty of:
|
● |
successful enrolment in,
and completion of clinical trials; |
|
|
|
|
● |
performing preclinical
studies and clinical trials in compliance with the FDA or any comparable regulatory authority requirements; |
|
|
|
|
● |
the ability to outsource
the manufacture of our products for development, clinical trials and/ or potential commercialization; |
|
|
|
|
● |
obtaining and maintaining
patent, trademark and trade secret protection for our products; |
|
|
|
|
● |
scaling the commercial
sales of products, if and when approved, whether alone or in collaboration with others; |
|
|
|
|
● |
acceptance of existing
therapies, and future therapies, if and when approved, by healthcare providers, physicians, clinicians, patients and third-party
payors; |
|
|
|
|
● |
competing effectively with
other therapies; |
|
|
|
|
● |
obtaining and maintaining
healthcare coverage and adequate reimbursement; |
|
|
|
|
● |
protecting our rights in
our intellectual property portfolio; and |
|
|
|
|
● |
maintaining a continued
acceptable safety profile of our products following approval. |
Liquidity
and Capital Resources
As
of September 30, 2024, the Company had a significant accumulated deficit of $81.8 million. For the nine months ended September 30,
2024, the Company had a loss from operations of $4.9 million and negative cash flows from operations of $2.8 million. The Company’s
operating activities consume the majority of its cash resources. The Company will continue to service existing customers in the United
States. The Company anticipates that it will continue to incur operating losses as it executes its development plans through 2024, as
well as other potential strategic and business development initiatives. In addition, the Company has had and expects to have negative
cash flows from operations, at least into the near future. The Company previously funded these losses primarily through the sale of equity.
As of September 30, 2024, the Company had cash and cash equivalents on hand of approximately $4.6 million.
Our
ability to continue as a going concern will be dependent upon our ability to execute on our business plan, including the ability to generate
revenue from the joint venture and obtain U.S. approval for the sale of our devices in the United States, and, if necessary, our ability
to raise additional capital. Although no assurances can be given as to our ability to deliver on our revenue plans or that unforeseen
expenses may arise, management has evaluated the significance of the conditions as of September 30, 2024 and have concluded that
we will not have sufficient cash and short-term investments to satisfy our anticipated cash requirements for the next twelve months from
the issuance of these financial statements.
Critical
Accounting Estimates
The
preparation of financial statements and related disclosures in conformity with GAAP and the Company’s discussion and analysis of
its financial condition and operating results require the Company’s management to make judgments, assumptions and estimates that
affect the amounts reported. Note 3, “Summary of Significant Accounting Policies and New Accounting Standards” of the Notes
to Condensed Consolidated Financial Statements in Part I, Item 1 of this Form 10-Q and in the Notes to Consolidated Financial
Statements in Part II, Item 8 of the 2023 Form 10-K describe the significant accounting policies and methods used in the preparation
of the Company’s condensed consolidated financial statements. There have been no material changes to the Company’s critical
accounting estimates since the 2023 Form 10-K.
Recent
Accounting Pronouncements
In
August of 2023, the FASB issued ASU 2023-05, Business Combinations—Joint Venture (“JV”) Formations: Recognition and
Initial Measurement. The guidance requires newly formed JVs to apply a new basis of accounting to all of its contributed net assets,
which results in the JV initially measuring its contributed net assets under ASC 805-20, Business Combinations. The new guidance would
be applied prospectively and is effective for all newly formed joint venture entities with a formation date on or after January 1,
2025, with early adoption permitted. The Company is evaluating the accounting and disclosure requirements of this update and does not
expect them to have a material effect on the consolidated financial statements.
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The
ASU expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided
to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description
of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. All disclosure
requirements under ASU 2023-07 are also required for public entities with a single reportable segment. The ASU is effective on a retrospective
basis for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15,
2024. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures.
In
December of 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, establishes incremental
disaggregation of income tax disclosures pertaining to the effective tax rate reconciliation and income taxes paid. This standard is
effective for fiscal years beginning after December 15, 2024, and requires prospective application with the option to apply it retrospectively.
Early adoption is permitted. The Company is currently evaluating the potential impact of adopting this standard on our disclosures.
All
other newly issued but not yet effective accounting pronouncements have been deemed to be not applicable or immaterial to the Company.
Contractual
Obligations
See
Note 7 – Commitments and Contingencies in the Notes to Unaudited Condensed Consolidated Financial Statements in Part I, Item 1
of this Form 10-Q for a summary of our contractual obligations.
Continued
Nasdaq Listing
Minimum
Bid Price Requirement
On
May 10, 2023, the Company received written notice from The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company
that it was no longer in compliance with the minimum bid price requirement for continued listing on Nasdaq, as the closing bid price
for the Company’s common stock was below $1.00 per share as set forth in the Nasdaq listing rules. The Company was afforded 180
calendar days, or until November 6, 2023, to regain compliance with the Nasdaq listing rules. The Company was unable to regain compliance
with the bid price requirement by November 6, 2023.
The
Company requested a second 180-day period in order to regain compliance with Nasdaq Rule 5550(a)(2). On January 18, 2024,
the Nasdaq Hearing Panel granted the Company a temporary exception to regain compliance with the Minimum Bid Price Rule until
March 27, 2024, which date was further extended by the Panel until April 25, 2024. On April 23, 2024, the Company
received notice from Nasdaq notifying the Company that it has regained compliance with Nasdaq’s minimum bid price requirement
under Nasdaq Rule 5550(a)(2).
On
September 23, 2024, we received a notice from Nasdaq notifying us that we were not in compliance with the Minimum Bid Price Rule.
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we had 180 calendar days, or until March 24, 2025, to regain compliance
with Nasdaq Listing Rule 5450(a)(1). To regain compliance, the closing bid price of our common stock must be at least $1.00 per
share for a minimum of 10 consecutive business days. On October 31, 2024, the Company received notice from Nasdaq notifying the
Company that it has regained compliance with Nasdaq’s minimum bid price requirement under Nasdaq Rule 5550(a)(2).
Minimum
Stockholder Equity Requirement
Under
the Nasdaq listing rules, we are also required to maintain stockholders’ equity of at least $2,500,000 (the “Minimum Stockholder
Equity Rule”). In our Form 10-Q for the period ending March 31, 2024, we reported stockholders’ equity of $2,326,987.
On May 16, 2024, we received a letter from the Listing Qualifications Department of Nasdaq notifying the Company that its stockholders’
equity as reported in such Quarterly Report did not satisfy the continued listing requirement under Nasdaq Listing Rule 5550(b)(1)
for the Nasdaq Capital Market.
Pursuant
to the Notice, the Company had 45 calendar days from the date of the Notice to submit a plan to regain compliance. On July 1, 2024,
the Company submitted a plan to Nasdaq. As described in the Company’s submission to Nasdaq, and as set forth in
the Current Report on Form 8-K filed by the Company on July 3, 2024, the Company consummated the public offering of
3 million shares of the Company’s Common Stock for total aggregate gross proceeds of approximately $5,250,000. On July 23,
2024, the Company received written notification from the Listing Qualifications Department of Nasdaq, confirming that, based on the information
contained in the Company’s Form 8-K, filed with the SEC on July 16, 2024, the Company is now in compliance with the Minimum
Stockholder Equity Rule.
Item 3.
Quantitative and Qualitative Disclosures about Market Risk
Not
Applicable. As a smaller reporting company, we are not required to provide the information required by this Item.
Item 4.
Disclosure Controls and Procedures
We
have adopted and maintain disclosure controls and procedures that are designed to provide reasonable assurance that information required
to be disclosed in the reports filed under the Exchange Act, such as this Quarterly Report on Form 10-Q, is collected, recorded,
processed, summarized and reported within the time periods specified in the rules of the SEC. Our disclosure controls and procedures
are also designed to ensure that such information is accumulated and communicated to management to allow timely decisions regarding required
disclosure. As required under Exchange Act Rule 13a-15, our management, including our Chief Executive Officer and our Chief Financial
Officer, has conducted an evaluation of the effectiveness of disclosure controls and procedures as of the end of the period covered by
this report. Based upon that evaluation, management identified material weaknesses in our internal control over financial reporting.
The material weaknesses identified to date include: (i) lack of sufficient resources necessary to provide adequate segregation of duties
related to the preparation and review of financial information used in financial reporting and review of controls over the financial
reporting process, including documentation of review of reconciliations; and (ii) insufficient IT controls which are effectively designed
and implemented, specifically related to user/superuser access to the Company’s financial reporting system.
As
of September 30, 2024, based on evaluation of these disclosure controls and procedures, management concluded that our disclosure
controls and procedures were not effective. To address our material weakness, we intend to engage an outside firm to advise on our financial
reporting processes and intend to implement new financial accounting controls and processes. We intend to continue to take steps to remediate
the material weakness described above through implementing enhancements and controls within our accounting systems, subject to budget
limitations. We will not be able to remediate these control deficiencies until these steps have been completed and have been operating
effectively for a sufficient period of time and management has concluded, through testing, that the controls are operating effectively.
The redesign and implementation of improvements to our accounting and proprietary systems and controls may be costly and time consuming
and the cost to remediate may impair our results of operations in the future.
In
light of the conclusion that our disclosure controls and procedures were not effective at September 30, 2024, we have applied particular
procedures and processes as necessary to ensure the reliability of our financial reporting with respect to this quarterly report. Accordingly,
we believe, based on our knowledge that: (i) this quarterly report does not contain any untrue statement of material fact or omit a statement
of material fact necessary to make the statements made, in light of the circumstances under which they were made, not misleading with
respect to the period covered by this report; and (ii) the consolidated financial statements, and other financial information included
in this quarterly report, fairly present in all material respects our financial condition, results of operations, and cash flows as of
and for the periods presented in this quarterly report.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) of the
Exchange Act) during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
PART
II — OTHER INFORMATION
Item 1.
Legal Proceedings
None.
Item 1A.
Risk Factors.
While
we attempt to identify, manage and mitigate risks and uncertainties associated with our business to the extent practical under the circumstances,
some level of risk and uncertainty will always be present. The risk factors set forth in our Registration Statement on Form S-1 (SEC
File Number 333-279684) as declared effective by the Securities and Exchange Commission on June 27, 2024 and the Prospectus contained
therein describe some of the risks and uncertainties associated with our business. These risks and uncertainties have the potential to
materially affect our results of operations and our financial condition.
There
have been no material changes from the risk factors previously disclosed in such filings.
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds from Registered Securities
None.
Item 3.
Defaults Upon Senior Securities
None.
Item 4.
Mine Safety Disclosures
Not
applicable.
Item 5.
Other Information
None.
Item 6.
Exhibits
Exhibits
and Financial Statement Schedules.
Exhibit
Number |
|
Description
of Document |
3.1 * |
|
Certificate
of Incorporation, as amended and as currently in effect. |
3.2 * |
|
Amended
and Restated Bylaws. |
4.1 * |
|
Form
of Specimen stock certificate evidencing shares of common stock. |
4.2 ** |
|
Warrant
Agreement between the Company and Continental Stock Transfer and Trust company as warrant agent dated as of September 16, 2022 |
4.3 * |
|
Form
of Warrant Certificate (filed as part of Exhibit 4.2) |
10.1 **** |
|
Joint
Venture Agreement between the Company and Wider Come Limited dated as of May 31, 2023. |
10.2 **** |
|
Employment
Agreement between the Company and Mark White dated as of July 1, 2023. |
10.3 **** |
|
Services
Agreement between the Company and David Owens, M.D. dated as of July 1, 2023. |
10.4 * |
|
Quality
Assurance Agreement between the Company and Apical Instruments dated December 31, 2020. |
10.5 * |
|
Advisor
Agreement with Leonard Osser dated as of December 22,2021. |
10.6 * |
|
Advisor
Agreement with Tucker Anderson dated as of December 24, 2021. |
10.7 * |
|
Advisor
Agreement with Gian Domenico Trombetta dated December 24, 2021. |
10.8 * |
|
Employment
Agreement between the Company and Marilyn Elson dated as of January 11, 2022 |
10.9 * |
|
Amendment
and Deferral Agreement dated as of March 30, 2022 to Consulting Agreement between the Company and US Asian Consulting Group
LLC |
10.10 **** |
|
Employment
Agreement between the Company and Michael Nketiah dated as of July 1, 2023. |
10.11 * |
|
Form
of Lock-Up Agreement. |
10.12 * |
|
Consulting
Agreement dated as of May 9, 2018 as amended between the Company and US Asian Consulting Group, LLC, as amended on January 2,
2019 and March 4, 2021 |
10.13 *** |
|
Amended
and Restated Promissory Note in favor of Mark White dated as of January 1, 2023. |
10.14 * |
|
Distribution
Authorization Agreement dated as of May 1, 2019 with Wider Come Limited. |
10.15 ***** |
|
Form of Lock-Up Agreement. |
10.16 ***** |
|
Form of Securities Purchase Agreement. |
10.17 ⸹ |
|
Placement
Agency Agreement |
10.18 ⸹⸹ |
|
Letter Agreement between the Company and Carolyn Shelton |
31.1 ⸹⸹⸹ |
|
Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended. |
32.1 ⸹⸹⸹ |
|
Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
99.1 * |
|
Code
of Ethics |
99.2 * |
|
Audit
Committee Charter |
99.3 * |
|
Compensation
Committee Charter |
99.4 * |
|
Nominating
and Corporate Governance Committee Charter |
* |
Previously filed as an
exhibit to Form S-1 as declared effective by the SEC on September 15, 2022 (SEC File Number 333-261989). |
** |
Previously filed as an
exhibit to Form 8-K/A as filed with the SEC on September 20, 2022. |
*** |
Previously filed as an
exhibit to Form 10-Q as filed with the SEC on May 10, 2023. |
**** |
Previously filed as an
exhibit to Form 10-Q as filed with the SEC on August 10, 2023. |
***** |
Previously filed as an
exhibit to Form S-1 as declared effective by the SEC on June 27, 2024 (SEC File Number 333-279684). |
⸹ |
Previously
filed as an exhibit to Form 8-K as filed with the SEC on July 3, 2024. |
⸹⸹ |
Previously
filed as an Exhibit to Form 8-K as filed with the SEC on September 19, 2024. |
⸹⸹⸹ |
Filed as an exhibit to
this Form 10-Q. |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report on Form 10-Q to be signed
on its behalf by the undersigned thereunto duly authorized on the 8th day of November, 2024.
|
NEXALIN TECHNOLOGY, INC. |
|
|
|
|
By: |
/s/ Mark
White |
|
|
Mark White |
|
|
Chief
Executive Officer |
|
|
Principal
Executive Officer |
|
|
Principal Financial Officer |
Exhibit 31.1
CERTIFICATION PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
(18 U.S.C. SECTION 1350)
I, Mark White, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of Nexalin
Technology, Inc. |
| 2. | Based on my knowledge, this report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under
which such statements were made, not misleading with respect to the period covered by this report. |
| 3. | Based on my knowledge, the financial statements, and other financial
information included in this report, fairly present in all material respects the financial condition, results of operations and cash
flows of the registrant as of, and for, the periods presented in this report. |
| 4. | The registrant’s other certifying officer(s) and I are responsible
for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and
internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) (Paragraph omitted pursuant to SEC Release Nos. 33-8238/34-47986 and 33-8392/34-49313);
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
| 5. | I have
disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the
audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: November 8, 2024 |
NEXALIN TECHNOLOGY, INC. |
|
|
|
|
By: |
/s/
Mark White |
|
|
Mark White |
|
|
Chief Executive Officer, |
|
|
Principal Executive Officer
Principal Financial Officer
|
Exhibit 32.1
CERTIFICATIONS OF THE CHIEF EXECUTIVE OFFICER
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
The undersigned hereby certifies, in
accordance with 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, in his capacity as an
officer of NEXALIN TECHNOLOGY, INC., that, to his or her knowledge, the Quarterly Report of Nexalin Technology, Inc. on Form 10-Q
for the period ended September 30, 2024 fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934
and that the information contained in such report fairly presents, in all material respects, the financial condition and results of
operation of the company.
A signed original of this written statement required by Section 906 has been provided to NEXALIN TECHNOLOGY, INC and will be retained by NEXALIN TECHNOLOGY, INC and furnished to the Securities and Exchange Commission or its staff upon request.
Date: November 8, 2024 |
NEXALIN TECHNOLOGY, INC. |
|
|
|
|
By: |
/s/
Mark White |
|
|
Mark White |
|
|
Chief Executive Officer |
|
|
Principal Executive Officer
Principal Financial Officer |
v3.24.3
Cover - shares
|
9 Months Ended |
|
Sep. 30, 2024 |
Nov. 06, 2024 |
Document Type |
10-Q
|
|
Amendment Flag |
false
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true
|
|
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|
|
Document Period End Date |
Sep. 30, 2024
|
|
Document Fiscal Period Focus |
Q3
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-41507
|
|
Entity Registrant Name |
NEXALIN TECHNOLOGY, INC.
|
|
Entity Central Index Key |
0001527352
|
|
Entity Tax Identification Number |
27-5566468
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
1776 Yorktown
|
|
Entity Address, Address Line Two |
Suite 550
|
|
Entity Address, City or Town |
Houston
|
|
Entity Address, State or Province |
TX
|
|
Entity Address, Postal Zip Code |
77056
|
|
City Area Code |
832
|
|
Local Phone Number |
260-0222
|
|
Entity Current Reporting Status |
Yes
|
|
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Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
true
|
|
Elected Not To Use the Extended Transition Period |
false
|
|
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false
|
|
Entity Common Stock, Shares Outstanding |
|
12,861,605
|
Common stock, par value $0.001 per share |
|
|
Title of 12(b) Security |
Common stock, par value $0.001 per share
|
|
Trading Symbol |
NXL
|
|
Security Exchange Name |
NASDAQ
|
|
Warrants, exercisable for one share of Common Stock |
|
|
Title of 12(b) Security |
Warrants, exercisable for one share of Common Stock
|
|
Trading Symbol |
NXLIW
|
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Security Exchange Name |
NASDAQ
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v3.24.3
CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)
|
Sep. 30, 2024 |
Dec. 31, 2023 |
Current Assets: |
|
|
Cash and cash equivalents |
$ 81,421
|
$ 580,230
|
Short-term investments |
4,512,197
|
2,368,203
|
Accounts receivable (Includes related party of $540 and $3,614, respectively) |
15,171
|
9,369
|
Inventory |
158,375
|
156,420
|
Prepaid expenses and other current assets |
140,425
|
315,670
|
Total Current Assets |
4,907,589
|
3,429,892
|
ROU Asset |
|
496
|
Intangible assets, net |
248,942
|
105,528
|
Equity method investment |
100,651
|
96,000
|
Total Assets |
5,257,182
|
3,631,916
|
Current Liabilities: |
|
|
Accounts payable |
166,542
|
159,534
|
Accrued expenses |
132,847
|
261,284
|
Lease liability, current portion |
|
4,463
|
Total Current Liabilities |
299,389
|
425,281
|
Total Liabilities |
299,389
|
425,281
|
Stockholders’ Equity: |
|
|
Common stock, $0.001 par value; 100,000,000 shares authorized; 12,861,605 shares issued and outstanding at September 30, 2024 and 7,436,852 shares issued and outstanding at December 31, 2023 |
12,862
|
7,437
|
Accumulated other comprehensive loss |
(325)
|
(405)
|
Additional paid in capital |
86,757,212
|
80,237,652
|
Accumulated deficit |
(81,811,956)
|
(77,038,049)
|
Total Stockholders’ Equity |
4,957,793
|
3,206,635
|
Total Liabilities and Stockholders’ Equity |
$ 5,257,182
|
$ 3,631,916
|
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v3.24.3
CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - USD ($)
|
Sep. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Accounts receivable, related party |
$ 540
|
$ 3,614
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
Common stock, shares issued |
12,861,605
|
7,436,852
|
Common stock, shares outstanding |
12,861,605
|
7,436,852
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.3
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Revenues, net (Includes related party of $868 and $0 for the three months ended and $3,102 and $10,207 for the nine months ended, respectively) |
$ 36,031
|
$ 24,113
|
$ 141,542
|
$ 90,212
|
Cost of revenues |
12,694
|
3,973
|
29,097
|
20,457
|
Gross profit |
23,337
|
20,140
|
112,445
|
69,755
|
Operating expenses: |
|
|
|
|
Professional fees |
262,303
|
127,202
|
731,099
|
405,949
|
Salaries and benefits |
294,175
|
363,330
|
928,072
|
965,988
|
Selling, general and administrative |
1,975,376
|
1,945,145
|
3,332,524
|
2,769,641
|
Total operating expenses |
2,531,854
|
2,435,677
|
4,991,695
|
4,141,578
|
Loss from operations |
(2,508,517)
|
(2,415,537)
|
(4,879,250)
|
(4,071,823)
|
Other income (expense), net: |
|
|
|
|
Interest income (expense), net |
1,000
|
(5,330)
|
1,370
|
(19,685)
|
Gain on sale of short-term investments |
56,250
|
82,943
|
92,915
|
180,593
|
Other income |
2,851
|
40,735
|
6,407
|
42,875
|
Total other income (expense), net |
60,101
|
118,348
|
100,692
|
203,783
|
Loss before equity in net earnings of affiliate |
(2,448,416)
|
(2,297,189)
|
(4,778,558)
|
(3,868,040)
|
Equity in net earnings of affiliate |
159
|
|
4,651
|
|
Net loss |
(2,448,257)
|
(2,297,189)
|
(4,773,907)
|
(3,868,040)
|
Other comprehensive income (loss): |
|
|
|
|
Unrealized gain (loss) from short-term investments |
(325)
|
(32,289)
|
80
|
(35,513)
|
Comprehensive loss |
$ (2,448,582)
|
$ (2,329,478)
|
$ (4,773,827)
|
$ (3,903,553)
|
Net loss per share attributable to common stockholders - Basic |
$ (0.23)
|
$ (0.31)
|
$ (0.55)
|
$ (0.53)
|
Net loss per share attributable to common stockholders - Diluted |
$ (0.23)
|
$ (0.31)
|
$ (0.55)
|
$ (0.53)
|
Weighted Average Shares Outstanding - Basic |
10,847,476
|
7,415,366
|
8,606,357
|
7,330,128
|
Weighted Average Shares Outstanding - Diluted |
10,847,476
|
7,415,366
|
8,606,357
|
7,330,128
|
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v3.24.3
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT) (Unaudited) - USD ($)
|
Common Stock [Member] |
AOCI Attributable to Parent [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Dec. 31, 2022 |
$ 7,287
|
$ 36,313
|
$ 77,824,427
|
$ (72,389,340)
|
$ 5,478,687
|
Beginning balance, shares at Dec. 31, 2022 |
7,286,562
|
|
|
|
|
Other comprehensive loss |
|
4,756
|
|
|
4,756
|
Net loss |
|
|
|
(748,414)
|
(748,414)
|
Ending balance, value at Mar. 31, 2023 |
$ 7,287
|
41,069
|
77,824,427
|
(73,137,754)
|
4,735,029
|
Ending balance, shares at Mar. 31, 2023 |
7,286,562
|
|
|
|
|
Other comprehensive loss |
|
(7,980)
|
|
|
(7,980)
|
Stock compensation |
|
|
88,388
|
|
88,388
|
Net loss |
|
|
|
(822,437)
|
(822,437)
|
Ending balance, value at Jun. 30, 2023 |
$ 7,287
|
33,089
|
77,912,815
|
(73,960,191)
|
3,993,000
|
Ending balance, shares at Jun. 30, 2023 |
7,286,562
|
|
|
|
|
Other comprehensive loss |
|
(32,289)
|
|
|
(32,289)
|
Stock compensation |
$ 150
|
|
1,573,020
|
|
1,573,170
|
Stock compensation, shares |
150,000
|
|
|
|
|
Net loss |
|
|
|
(2,297,189)
|
(2,297,189)
|
Ending balance, value at Sep. 30, 2023 |
$ 7,437
|
800
|
79,485,835
|
(76,257,380)
|
3,236,692
|
Ending balance, shares at Sep. 30, 2023 |
7,436,562
|
|
|
|
|
Beginning balance, value at Dec. 31, 2023 |
$ 7,437
|
(405)
|
80,237,652
|
(77,038,049)
|
3,206,635
|
Beginning balance, shares at Dec. 31, 2023 |
7,436,562
|
|
|
|
|
Other comprehensive loss |
|
160
|
|
|
160
|
Stock compensation |
|
|
161,349
|
|
161,349
|
Net loss |
|
|
|
(1,041,157)
|
(1,041,157)
|
Ending balance, value at Mar. 31, 2024 |
$ 7,437
|
(245)
|
80,399,001
|
(78,079,206)
|
2,326,987
|
Ending balance, shares at Mar. 31, 2024 |
7,436,562
|
|
|
|
|
Other comprehensive loss |
|
245
|
|
|
245
|
Stock compensation |
|
|
308,283
|
|
308,283
|
Shares issued |
$ 150
|
|
(150)
|
|
|
Shares issued, shares |
150,000
|
|
|
|
|
Net loss |
|
|
|
(1,284,493)
|
(1,284,493)
|
Ending balance, value at Jun. 30, 2024 |
$ 7,587
|
|
80,707,134
|
(79,363,699)
|
1,351,022
|
Ending balance, shares at Jun. 30, 2024 |
7,586,562
|
|
|
|
|
Other comprehensive loss |
|
(325)
|
|
|
(325)
|
Stock compensation |
$ 2,275
|
|
1,536,894
|
|
1,539,169
|
Stock compensation, shares |
2,275,043
|
|
|
|
|
Shares issued in offering |
$ 3,000
|
|
4,513,184
|
|
4,516,184
|
Shares issued in offering, shares |
3,000,000
|
|
|
|
|
Net loss |
|
|
|
(2,448,257)
|
(2,448,257)
|
Ending balance, value at Sep. 30, 2024 |
$ 12,862
|
$ (325)
|
$ 86,757,212
|
$ (81,811,956)
|
$ 4,957,793
|
Ending balance, shares at Sep. 30, 2024 |
12,861,605
|
|
|
|
|
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v3.24.3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)
|
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Cash flows from operating activities: |
|
|
Net loss |
$ (4,773,907)
|
$ (3,868,040)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Stock compensation |
2,008,801
|
1,661,558
|
Depreciation |
|
402
|
Amortization |
10,666
|
2,105
|
Non-cash lease expense |
496
|
4,208
|
Gain on sale of short-term investments |
(92,915)
|
(180,593)
|
Share of net income from equity method investment |
(4,651)
|
|
Changes in operating assets and liabilities: |
|
|
Accounts receivable |
(5,262)
|
(9,608)
|
Accounts receivable - related party |
(540)
|
|
Prepaid assets |
175,245
|
119,237
|
Inventory |
(1,955)
|
(4,249)
|
Accounts payable - related party |
|
(260,000)
|
Accounts payable |
7,008
|
(325,818)
|
Accrued expenses |
(128,437)
|
67,069
|
Lease liability |
(4,463)
|
(37,625)
|
Net cash used in operating activities |
(2,809,914)
|
(2,831,354)
|
Cash flows from investing activities: |
|
|
Sale of short-term investments |
22,348,611
|
32,671,394
|
Purchase of short-term investments |
(24,399,610)
|
(29,270,926)
|
Purchase of patents |
(101,936)
|
(96,000)
|
Purchase of trademarks |
(52,144)
|
(74,460)
|
Net cash provided by (used in) investing activities |
(2,205,079)
|
3,230,008
|
Cash flows from financing activities: |
|
|
Payments on notes payable - officer |
|
(200,000)
|
Issuance of common stock |
4,516,184
|
|
Net cash provided by (used in) financing activities |
4,516,184
|
(200,000)
|
Net increase (decrease) in cash and cash equivalents |
(498,809)
|
198,654
|
Cash and cash equivalents - beginning of period |
580,230
|
162,743
|
Cash and cash equivalents - end of period |
81,421
|
361,397
|
Non-cash investing and financing activities: |
|
|
Unrealized gain (loss) on short-term investments |
$ 80
|
$ (35,513)
|
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Pay vs Performance Disclosure - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Pay vs Performance Disclosure [Table] |
|
|
|
|
Net Income (Loss) |
$ (2,448,257)
|
$ (2,297,189)
|
$ (4,773,907)
|
$ (3,868,040)
|
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v3.24.3
NATURE OF THE ORGANIZATION AND BUSINESS
|
9 Months Ended |
Sep. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
NATURE OF THE ORGANIZATION AND BUSINESS |
NOTE
1 — NATURE OF THE ORGANIZATION AND BUSINESS
Corporate
History
Nexalin
Technology, Inc. (“NV Nexalin”) was formed on October 19, 2010 as a Nevada corporation. The Company’s principal
offices are located at 1776 Yorktown, Suite 550, Houston, Texas 77056.
On
September 6, 2019, Neuro-Health International, Inc. (“Neuro-Health”), a Nevada corporation, a wholly owned subsidiary
of NV Nexalin, was formed. Neuro-Health had no activity from December 6, 2019 (Inception) through September 30, 2024.
Our
shares and warrants began trading on the Nasdaq Capital Market tier of the Nasdaq Stock Market (“Nasdaq”) on September 16,
2022, under the symbols “NXL” and “NXLIW”, respectively.
On
July 1, 2024, we consummated a follow-on public offering of an aggregate of 3,000,000 shares of the Common Stock for an offering
price of $1.75 per share, resulting in aggregate net proceeds of approximately $4,720,000. The Company intends to use the
net proceeds of such offering primarily for general corporate purposes, which may include, but is not limited to, working capital, operating
expenses, and capital expenditures.
Throughout
this report, the terms “Nexalin,” “our,” “we,” “us,” and the “Company” refer
to Nexalin Technology, Inc.
Business
Overview
Nexalin
is headquartered, and maintains its base of management and operations, in Houston, Texas. We design and develop innovative neurostimulation
products to uniquely and effectively help combat the ongoing global mental health epidemic. We developed an easy-to-administer medical
device — referred to as “Generation 1” or “Gen-1” — that utilizes bioelectronic medical technology
to treat anxiety, insomnia, and depression, without the need for drugs or psychotherapy. Our original Gen-1 devices are cranial electrotherapy
stimulation (CES) devices that emit waveform at 4 milliamps during treatment and are presently classified by the U.S. Food and Drug Administration
(the “FDA”) as a Class II device.
Medical professionals in the United States have
utilized the Gen-1 device to administer to patients in clinical settings. While the Gen-1 device had been cleared by the FDA to treat
depression, anxiety, and insomnia, three prevalent and serious diseases, because of the FDA’s December 2019 reclassification
of CES devices, the Gen-1 device was reclassified as a Class II device for the treatment of anxiety and insomnia. We are required to
file a new application under Section 510(k) of the Federal Food, Drug and Cosmetic Act (“510(k) Application”) to be
approved by the FDA for the sales and marketing of our devices for the treatment of anxiety and insomnia. In the FDA’s December 2019
reclassification ruling, the treatment of depression with our device will require a Class III certification and require a new PMA (premarket
approval) and/or a new De Novo application to demonstrate safety and effectiveness.
While
we continue providing services to medical professionals to support patients’ use of the Gen-1 devices which were in operation prior
to December 2019, we are not making new sales or new marketing efforts of Gen-1 devices in the United States. We continue to derive
revenue from devices which we sold or leased prior to the FDA’s December 2019 reclassification announcements. This revenue
consists of monthly licensing fees and payments for the sale of electrodes and patient cables. We have suspended marketing efforts for
new sales of devices related to the Gen-1 device for treatment of anxiety and insomnia in the United States until the Nexalin regulatory
team decides on a new 510(k) application at 4 milliamps based on FDA comments expected to be received in late 2024. Our regulatory team
continues to inform the FDA of the suspension of the marketing and sale of the Gen-1 products to new providers. We are currently analyzing
whether to proceed with an amended application with the FDA for Gen-1 devices for the treatment of insomnia and anxiety.
The waveform that comprises the basis of our “Generation
2” or “Gen-2” and new “Generation 3” or “Gen-3” headset devices is in pre-submission for review
by the FDA for safety evaluation and eventual marketing in the United States. Determinations of the safety and efficacy of our devices
in the United States are solely within the authority of the FDA. We plan to conduct decentralized clinical trials for the Gen-3 device
in the U.S. and we continue to consult with the FDA as part of the pre-submission process. If and when we obtain FDA clearance for the
Gen-3 device, we intend to extend the development and commercialization of our devices for sale in the U.S. and other territories, given
the potential unmet demand for the treatment of mental health conditions with our device.
We have designed and developed a new advanced
waveform technology to be emitted at 15 milliamps through new and improved medical devices referred to as Gen-2 and Gen-3. Gen-2 is a
clinical use device with a modern enclosure to emit the new 15 milliamp advanced waveform. Gen-3 is a new patient headset that will be
prescribed by licensed medical professionals in a virtual clinic setting similar to existing tele-health platforms. The Nexalin research
team believes that the new 15 milliamp Gen-2 and Gen-3 devices can penetrate deeper into the brain and stimulate associated structures
of mental illness, which we believe will generate enhanced patient response without any risk or unpleasant side effects. The Nexalin regulatory
team has made a strategic decision to develop strategies for pilot trials and/or pivotal trials in various mental health disease categories.
In addition, a new PMA application in the United States is in strategic development for the treatment of depression utilizing both Gen-2
and Gen-3. We plan to schedule additional pilot trials and/or pivotal trials for the new Gen-3 device for anxiety and insomnia in the
United States and China beginning in the fourth quarter of 2024 . Preliminary data provided by The University of California,
San Diego and recent published data from Asia supports the safety of utilizing our 15 milliamp waveform technology. However, the determination
of safety and efficacy of medical devices in the United States is subject to clearance by the FDA.
Currently, the waveform that comprises the basis
of Gen-2 and new Gen-3 headset devices has been tested in research settings to develop safety data that has been submitted for review
by the FDA for safety evaluation and eventual marketing in the United States and around the world. Determinations of the safety and efficacy
of our devices in the United States are solely within the authority of the FDA.
A new pre-submission document in preparation of
a new 510(k) and/or De Novo application for our Gen-3 HALO headset at 15 milliamps was filed with the FDA in January of 2023. Formal comments
to our pre-submission document filing were received in March of 2023. A formal meeting to address FDA comments took place on May 9,
2023.
A
second FDA pre-submission document was submitted on February 13, 2024. FDA comments to this second pre-submission document were
received on April 26, 2024. A formal teleconference was held with the FDA on April 30, 2024. The Nexalin regulatory team and
the FDA came to a consensus on the Anxiety and Insomnia Clinical research protocols.
On
May 31, 2023, the Company formalized an agreement related to the formation of a joint venture established to engage in the clinical
development, marketing, sale and distribution of Nexilin’s second generation transcranial Alternating Current Stimulation (“tACS”)
devices (“Gen-2 devices”) in China and other countries in the region. The Joint Venture is registered in Hong Kong.
Under
the Joint Venture Agreement, Wider Come Limited (“Wider”), a related party, is obligated to fund all operations for the
initial 12-month period of the Joint Venture, after which Nexalin and Wider plan to jointly fund the Joint Venture’s operating
expenses in accordance with their pro rata ownership. The Joint Venture conducts research, development and clinical studies of our
devices, which supplements similar activities being conducted by Nexalin in the United States. The Joint Venture is responsible for
funding all clinical trial and development costs incurred in China. We share associated economic responsibility for these expenses
under the terms of the Joint Venture Agreement. The Joint Venture may provide the financial resources for, and– together with
our clinical studies conducted in the U.S. - serve as an important regulatory precursor towards the advancement of our efforts in
securing 510(k) and/or De Novo clearance from the FDA for our devices.
As
of the date of this Quarterly Report on Form 10-Q, we have no employees or office in China and none of our operations are conducted
in China. The Joint Venture does not maintain any variable interest entity structure or operate any data center in China.
The
Joint Venture is controlled by a Board of Directors in which Wider is to have sole representation but neither the Company nor Wider has
exclusive decision-making ability over day-to-day or significant operational decisions. Wider and Nexalin own 52% and 48% of the Joint
Venture, respectively. In accordance with ASC 323 Investments - Equity Method and Joint Ventures (“ASC 323”) and ASC 810
- Consolidations (“ASC 810”), the Company recognized $159 and $0 for the three months ended September 30, 2024 and 2023
and $4,651 and $0 for the nine months ended September 30, 2024 and 2023 of equity method investment income from the Joint Venture
on a one-quarter reporting lag, on the condensed consolidated statements of operations and comprehensive loss.
The
investment in the Joint Venture is accounted for using the equity method of accounting. As of September 30, 2024 and December 31,
2023 the Company had an Equity Method Investment of $100,651 and $96,000, respectively, recorded on the condensed consolidated balance
sheets. The Company invested $96,000 in the joint venture in September 2023 which is recorded on the consolidated balance sheet
at December 31, 2023 as an Equity Method Investment. Wider invested $104,000. In accordance with ASC 323, the Company uses the equity
method of accounting for its investment in the Joint Venture, an unconsolidated entity over which it does not have a controlling interest.
The equity method of accounting requires the investment to be initially recorded at cost and subsequently adjusted for the Company’s
share of equity in the unconsolidated entity’s earnings or losses. The Company evaluates the carrying amount of this investment
in the Joint Venture for impairment in accordance with ASC 323. If the Company determines that a loss in the value of the investment
is other than temporary, the Company writes down the investment to its estimated fair value. Any such losses are recorded to equity in
income of unconsolidated entities in the Company’s consolidated statements of operations and comprehensive loss. The Company has
made an election to classify distributions received from the Joint Venture using the nature of the distribution approach. Distributions
received are classified as cash inflows from operating activities based on the nature of the activities of the unconsolidated entity.
Continued
Nasdaq Listing
Our
common stock is currently listed on The Nasdaq Stock Market. In order to maintain that listing, we must satisfy minimum financial and
other continued listing requirements and standards, including the Minimum Bid Price Rule and Minimum Stockholder Equity Rule (each as
discussed below) and those regarding director independence and independent committee requirements, minimum stockholders’ equity,
and certain corporate governance requirements. There can be no assurances that we will be able to comply with the applicable listing
standards.
We
are required to maintain a minimum bid price of $1.00 per share. On May 10, 2023, the Company received written notice from The Nasdaq
Stock Market LLC (“Nasdaq”) notifying the Company that it was no longer in compliance with the minimum bid price requirement
for continued listing on Nasdaq, as the closing bid price for the Company’s common stock was below $1.00 per share as set forth
in the Nasdaq listing rules. The Company was afforded 180 calendar days, or until November 6, 2023, to regain compliance with the
Nasdaq listing rules. The Company was unable to regain compliance with the bid price requirement by November 6, 2023.
The
Company requested a second 180-day period in order to regain compliance with Nasdaq Rule 5550(a)(2). On January 18, 2024, the
Nasdaq Hearing Panel granted the Company a temporary exception to regain compliance with the Minimum Bid Price Rule until March 27,
2024, which date was further extended by the Panel until April 25, 2024.
On
April 23, 2024, the Company received notice from Nasdaq notifying the Company that it has regained compliance with Nasdaq’s
minimum bid price requirement under Nasdaq Rule 5550(a)(2).
Under
the Nasdaq listing rules, we are also required to maintain stockholders’ equity of at least $2,500,000 (the “Minimum Stockholder
Equity Rule”). In our Form 10-Q for the period ending March 31, 2024, we reported stockholders’ equity of $2,326,987.
On May 16, 2024, we received a letter from the Listing Qualifications Department of Nasdaq notifying the Company that its stockholders’
equity as reported in such Quarterly Report did not satisfy the continued listing requirement under Nasdaq Listing Rule 5550(b)(1)
for the Nasdaq Capital Market.
Pursuant
to the Notice, the Company had 45 calendar days from the date of the Notice to submit a plan to regain compliance. On July 1, 2024,
the Company submitted a plan to Nasdaq. As described in the Company’s submission to Nasdaq, and as set forth in
the Current Report on Form 8-K filed by the Company on July 3, 2024, the Company consummated the public offering of
3 million shares of the Company’s Common Stock for total aggregate gross proceeds of approximately $5,250,000 On July 23,
2024, the Company received written notification from the Listing Qualifications Department of Nasdaq, confirming that, based on the information
contained in the Company’s Form 8-K, filed with the SEC on July 16, 2024, the Company is now in compliance with the Minimum
Stockholder Equity Rule.
On
September 23, 2024, we received a notice from Nasdaq notifying us that we were not in compliance with the Minimum Bid Price Rule.
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we had 180 calendar days, or until March 24, 2025, to regain compliance
with Nasdaq Listing Rule 5450(a)(1). To regain compliance, the closing bid price of our common stock must be at least $1.00 per
share for a minimum of 10 consecutive business days. On October 31, 2024, the Company received notice from Nasdaq notifying the
Company that it has regained compliance with Nasdaq’s minimum bid price requirement under Nasdaq Rule 5550(a)(2).
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- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward.
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v3.24.3
LIQUIDITY
|
9 Months Ended |
Sep. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
LIQUIDITY |
NOTE
2 — LIQUIDITY
The
accompanying unaudited condensed consolidated financial statements have been prepared on the basis that the Company will continue as
a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. At September 30,
2024, the Company had a significant accumulated deficit of approximately(81,811,956) $81.8 million. For the nine months ended September 30,
2024, the Company had a loss from operations of approximately(4,879,250) $4.9 million and negative cash flows from operations of approximately(2,809,914) $2.8
million. While the Company had a working capital surplus as of September 30, 2024 of approximately $4.6 million, the Company’s
operating activities consume most of its cash resources.
The
Company expects to continue to incur operating losses as it executes its development plans, as well as undertaking other potential strategic
and business development initiatives through 2024 and through the twelve months from the date of this report. In addition, the Company
has had and expects to have negative cash flows from operations, at least into the near future. We previously funded these losses primarily
through the sale of equity. These factors, among others, raise substantial
doubt about the ability of the Company to continue as a going concern for a reasonable period.
Our
ability to continue as a going concern will be dependent upon our ability to execute on our business plan, including the ability to generate
revenue from the joint venture and obtain U.S. approval for the sale of our devices in the United States, and, if necessary, our ability
to raise additional capital. Although no assurances can be given as to our ability to deliver on our revenue plans or that unforeseen
expenses may arise, management has evaluated the significance of the conditions as of September 30, 2024 and have concluded that
we will not have sufficient cash and short-term investments to satisfy our anticipated cash requirements for the next twelve months from
the issuance of these financial statements. The accompanying unaudited condensed consolidated financial statements do not include any
adjustments that might be necessary should we be unable to continue as a going concern.
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v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NEW ACCOUNTING STANDARDS
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NEW ACCOUNTING STANDARDS |
NOTE
3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NEW ACCOUNTING STANDARDS
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with Generally Accepted Accounting
Principles in the United States (“GAAP”). In the opinion of management, such financial information includes all adjustments
(consisting only of normal recurring adjustments) considered necessary for a fair presentation of the Company’s financial position
and the operating results and cash flows. Operating results for the nine months ended September 30, 2024 and 2023 are not necessarily
indicative of the results that may be expected for any other subsequent interim period. Certain information and footnote disclosures
normally included in consolidated financial statements prepared in accordance with GAAP have been omitted pursuant to the rules of the
SEC. These unaudited condensed consolidated financial statements and related notes should be read in conjunction with the Company’s
audited consolidated financial statements for the year ended December 31, 2023.
Principles
of Consolidation
The
unaudited condensed consolidated financial statements include the accounts of Nexalin and its wholly owned subsidiary Neuro-Health. Intercompany
accounts and transactions have been eliminated in consolidation.
Use
of Estimates
The
preparation of the unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates
and assumptions that affect the reported amounts of assets, liabilities, equity-based transactions, revenue and expenses and disclosure
of contingent liabilities at the date of the consolidated financial statements. The Company bases its estimates and assumptions on historical
experience, known or expected trends and various other assumptions that it believes to be reasonable. As future events and their effects
cannot be determined with precision, actual results could differ from these estimates, which may cause the Company’s future results
to be affected.
Revenue
The
Company recognizes revenue when its performance obligations with its customers have been satisfied. At contract inception, the Company
determines if the contract is within the scope of Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts
with Customers, and then evaluates the contract using the following five steps: (1) identify the contract with the customer; (2)
identify the performance obligations; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations;
and (5) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only recognizes revenue to the extent
that it is probable that a significant revenue reversal will not occur in a future period.
The
Company has existing licensing and treatment fee agreements with its customers for the use of the Nexalin Device in their practices.
These agreements generally have terms of one year with automatic renewal if certain requirements are met and amounts due per these agreements
are billed monthly. The Company also sells products related to the provision of services. The Company sells its Devices in China to its
acting distributor and sells products relating to the use of the Devices. The Company has a Royalty Agreement whereby the manufacturer
of the Company’s electrodes will pay a royalty to the Company for a three-year period beginning January 1, 2022. The amount
of the Royalty is equal to 20% of the amount that the manufacturer invoices to the acting distributor for the sale of the electrodes.
Revenue
Streams
The
Company derives revenues from our license agreements by charging a monthly licensing fee for the duration of the agreement. The Company
derives revenues from equipment by selling additional individual electrodes to customers for use with the Nexalin Device. We receive
revenue from the sale in China of our Devices to our distributor and from the sale of products relating to the use of those Devices.
We derive revenue as a royalty fee from the China-based manufacturer for electrodes ordered in connection with our China sales.
Disaggregated
Revenues
Major
Revenue Streams
Revenue
consists of the following by service offering:
Schedule of disaggregation of revenue | |
| | | |
| | |
| |
Three Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Device sales | |
$ | - | | |
$ | - | |
Licensing fee | |
| 16,941 | | |
| 18,664 | |
Equipment | |
| 18,802 | | |
| 5,179 | |
Other | |
| 288 | | |
| 270 | |
Total | |
$ | 36,031 | | |
$ | 24,113 | |
| |
Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Device sales | |
$ | 55,500 | | |
$ | 9,600 | |
Licensing fee | |
| 54,561 | | |
| 62,566 | |
Equipment | |
| 30,423 | | |
| 16,679 | |
Other | |
| 1,058 | | |
| 1,367 | |
Total | |
$ | 141,542 | | |
$ | 90,212 | |
Major
Geographic Locations
| |
Three Months Ended
September 30, | |
| |
2024 | | |
2023 | |
U.S. sales | |
$ | 20,664 | | |
$ | 24,113 | |
International sales | |
| 15,367 | | |
| - | |
Total | |
$ | 36,031 | | |
$ | 24,113 | |
| |
Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | |
U.S. sales | |
$ | 65,523 | | |
$ | 80,005 | |
International sales | |
| 76,019 | | |
| 10,207 | |
Total | |
$ | 141,542 | | |
$ | 90,212 | |
Cash
and Cash Equivalents
The
Company considers all highly liquid investments with maturities of three months or less at the time of purchase to be cash equivalents.
Cash and cash equivalents held at financial institutions may at times exceed insured amounts. The Company believes it mitigates such
risk by investing in or through, as well as maintaining cash balances with, with major financial institutions.
Short-Term
Investments
The
appropriate classification of marketable securities is determined at the time of purchase and evaluated as of each reporting balance
sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair value
is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or
liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the
assets or liabilities. Unrealized holding gains and losses for equity securities are recognized in earnings. Unrealized holding gains
and losses for available for sale debt securities are recognized in other comprehensive income (loss.) Realized gains and losses and
interest and dividends earned are included in other income (expense), net. For individual debt securities classified as available-for-sale
securities, the Company determines whether a decline in fair value below the amortized cost basis has resulted from a credit loss or
other factors. If the decline below amortized cost is a result of credit loss or the Company will more likely than not be required to
sell the security before recovery of its amortized cost basis, the Company will recognize an impairment relating to the decline through
an allowance for credit losses. There were no deemed permanent impairments for the three and nine months ended September 30, 2024
and 2023, respectively.
Patents
and Trademarks
Patents
and trademarks are amortized over their useful lives and are reviewed for impairment when warranted by economic conditions. Amortization
expense was $10,666 and $2,105 for the nine months ended September 30, 2024 and 2023, respectively. Amortization expense was $4,211
and $753 for the three months ended September 30, 2024 and 2023, respectively.
The
following table summarizes the gross carrying amount, amortization and the net carrying value at September 30, 2024 and December 31,
2023.
Schedule of patents | |
| | | |
| | | |
| | |
| |
Gross Carrying
Amount | | |
Accumulated
Amortization | | |
Net Carrying
Value | |
September 30,
2024 | |
| | | |
| | | |
| | |
Patents | |
$ | 200,906 | | |
$ | (10,680 | ) | |
$ | 190,226 | |
Trademarks | |
| 62,717 | | |
| (4,001 | ) | |
| 58,716 | |
Total September 30, 2024 | |
$ | 263,623 | | |
$ | (14,681 | ) | |
$ | 248,942 | |
| |
| | | |
| | | |
| | |
December 31,
2023 | |
| | | |
| | | |
| | |
Patents | |
$ | 98,970 | | |
$ | (3,751 | ) | |
$ | 95,219 | |
Trademarks | |
| 10,573 | | |
| (264 | ) | |
| 10,309 | |
Total December 31, 2023 | |
$ | 109,543 | | |
$ | (4,015 | ) | |
$ | 105,528 | |
Income
Taxes
The
Company accounts for income taxes pursuant to the asset and liability method which requires the recognition of deferred income tax assets
and liabilities related to the expected future tax consequences arising from temporary differences between the carrying amounts and tax
bases of assets and liabilities based on enacted statutory tax rates applicable to the periods in which the temporary differences are
expected to reverse. Any effects of changes in income tax rates or laws are included in income tax expense in the period of enactment.
The
Company records valuation allowances against deferred tax assets when it is more likely than not that all or a portion of a deferred
tax asset will not be realized. At September 30, 2024 and December 31, 2023, the Company had a full valuation allowance applied
against its net tax assets.
Fair
Value Measurements
As
defined in ASC 820, Fair Value Measurements and Disclosures, fair value is the price that would be received to sell an asset or
paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company
utilizes market data or assumptions that market participants would use in pricing the asset or liability, including assumptions about
risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market corroborated, or
generally unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy
gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurement) and
the lowest priority to unobservable inputs (level 3 measurement). This fair value measurement framework applies at both initial and subsequent
measurement.
|
● |
Level 1: Quoted prices
are available in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions
for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. |
|
|
|
|
● |
Level 2: Pricing inputs
are other than quoted prices in active markets included in Level 1, which are either directly or indirectly observable as of the
reported date. Level 2 includes those financial instruments that are valued using models or other valuation methodologies. These
models are primarily industry-standard models that consider various assumptions, including quoted forward prices for commodities,
time value, volatility factors and current market and contractual prices for the underlying instruments, as well as other relevant
economic measures. Substantially all of these assumptions are observable in the marketplace throughout the full term of the instrument,
can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. |
|
|
|
|
● |
Level 3: Pricing inputs
include significant inputs that are generally less observable from objective sources. These inputs may be used with internally developed
methodologies that result in management’s best estimate of fair value. The significant unobservable inputs used in the fair
value measurement for nonrecurring fair value measurements of long-lived assets include pricing models, discounted cash flow methodologies
and similar techniques. |
Fair
Value of Financial Instruments
The
carrying value of cash, short-term investments, accounts receivable, inventory, prepaids, accounts payable and accrued expenses, and
other current liabilities approximate their fair values based on the short-term maturity of these instruments. The carrying amount of
the loans payable approximates the estimated fair value for this financial instrument as management believes that such debt and interest
payable on the note approximates the Company’s incremental borrowing rate.
The
following table summarizes the amortized cost, unrealized gain (loss) and the fair value at September 30, 2024 and December 31,
2023.
Schedule of unrealized loss on investments | |
| | | |
| | | |
| | |
| |
Amortized Cost | | |
Unrealized Gain
(Loss) | | |
Fair Value | |
September 30, 2024 | |
| | | |
| | | |
| | |
Short-term investments | |
$ | 4,512,522 | | |
$ | (325 | ) | |
$ | 4,512,197 | |
Total September 30, 2024 | |
$ | 4,512,522 | | |
$ | (325 | ) | |
$ | 4,512,197 | |
| |
| | | |
| | | |
| | |
December 31, 2023 | |
| | | |
| | | |
| | |
Short-term investments | |
$ | 2,368,608 | | |
$ | (405 | ) | |
$ | 2,368,203 | |
Total December 31, 2023 | |
$ | 2,368,608 | | |
$ | (405 | ) | |
$ | 2,368,203 | |
The
following table provides the carrying value and fair value of the Company’s financial assets measured at fair value as of September 30,
2024 and December 31, 2023.
Schedule of fair value, assets measured on recurring basis | |
| | | |
| | | |
| | | |
| | |
| |
Carrying Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
September 30, 2024 | |
| | | |
| | | |
| | | |
| | |
U.S. Treasury Notes | |
$ | 4,512,197 | | |
$ | 4,512,197 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
December 31, 2023 | |
| | | |
| | | |
| | | |
| | |
U.S. Treasury Notes | |
$ | 2,368,203 | | |
$ | 2,368,203 | | |
$ | - | | |
$ | - | |
As
defined in ASC 820, Fair Value Measurements and Disclosures, fair value is the price that would be received to sell an asset or paid
to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company utilizes
market data or assumptions that market participants would use in pricing the asset or liability, including assumptions about risk and
the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market corroborated, or generally
unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives
the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurement) and the
lowest priority to unobservable inputs (level 3 measurement). This fair value measurement framework applies at both initial and subsequent
measurement for the three months ended September 30, 2024 and 2023.
Net
Loss per Common Share
The
following table summarizes the securities that would be excluded from the diluted per share calculation because the effect of including
these potential shares was antidilutive due to the Company’s net loss position even though the exercise price could be less than
the most recent fair value of the common shares:
Schedule of antidilutive shares | |
| | | |
| | |
| |
Three Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 2,662,250 | | |
| 2,662,250 | |
Stock options | |
| 2,863,129 | | |
| - | |
Total | |
| 5,525,379 | | |
| 2,662,250 | |
| |
Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 2,662,250 | | |
| 2,662,250 | |
Stock options | |
| 2,863,129 | | |
| - | |
Total | |
| 5,525,379 | | |
| 2,662,250 | |
Stock-Based
Compensation
The
Company applies the provisions of ASC 718, Compensation — Stock Compensation (“ASC 718”), which requires the
measurement and recognition of compensation expense for all stock-based awards made to employees, including employee stock options, in
the condensed consolidated statements of operations and comprehensive loss.
For
stock options issued to employees and members of the board of directors for their services, the Company estimates the grant date fair
value of each option using the Black-Scholes option pricing model. The use of the Black-Scholes option pricing model requires management
to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the
expected life of the option, risk-free interest rates and expected dividend yields of the common stock. For awards subject to service-based
vesting conditions, including those with a graded vesting schedule, the Company recognizes stock-based compensation expense equal to
the grant date fair value of stock options on a straight-line basis over the requisite service period, which is generally the vesting
term. Forfeitures are recorded as they are incurred as opposed to being estimated at the time of grant and revised.
Pursuant
to ASU 2018-07 Compensation — Stock Compensation (Topic 718): Improvements to Non-employee Share-Based Payment Accounting, the
Company accounts for stock options and restricted shares issued to non-employees for their services in accordance with ASC 718. The Company
uses valuation methods and assumptions to value the stock options that are in line with the process for valuing employee stock options
noted above.
Research
and Development
Research
and development costs are charged to operations as incurred. For the nine months ended September 30, 2024 and 2023, the Company
recorded $453,643 and $1,842,341, respectively, in selling, general and administrative expenses on the unaudited condensed consolidated
statements of operations and comprehensive loss. For the three months ended September 30, 2024 and 2023, the Company recorded $178,565
and $1,638,508, respectively, in selling, general and administrative expenses on the unaudited condensed consolidated statements of operations
and comprehensive loss.
Recent
Accounting Pronouncements
In
August of 2023, the FASB issued ASU 2023-05, Business Combinations—Joint Venture (“JV”) Formations: Recognition and
Initial Measurement. The guidance requires newly formed JVs to apply a new basis of accounting to all of its contributed net assets,
which results in the JV initially measuring its contributed net assets under ASC 805-20, Business Combinations. The new guidance would
be applied prospectively and is effective for all newly formed joint venture entities with a formation date on or after January 1,
2025, with early adoption permitted. The Company is evaluating the accounting and disclosure requirements of this update and does not
expect them to have a material effect on the consolidated financial statements.
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The
ASU expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided
to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description
of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. All disclosure
requirements under ASU 2023-07 are also required for public entities with a single reportable segment. The ASU is effective on a retrospective
basis for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15,
2024. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures.
In
December of 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, establishes incremental
disaggregation of income tax disclosures pertaining to the effective tax rate reconciliation and income taxes paid. This standard is
effective for fiscal years beginning after December 15, 2024, and requires prospective application with the option to apply it retrospectively.
Early adoption is permitted. The Company is currently evaluating the potential impact of adopting this standard on our disclosures.
All
other newly issued but not yet effective accounting pronouncements have been deemed to be not applicable or immaterial to the Company.
|
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.24.3
ACCRUED EXPENSES
|
9 Months Ended |
Sep. 30, 2024 |
Payables and Accruals [Abstract] |
|
ACCRUED EXPENSES |
NOTE
4 — ACCRUED EXPENSES
Accrued
expenses consist of the following amounts:
Schedule of accrued expenses | |
| | | |
| | |
| |
September 30,
2024 | | |
December 31,
2023 | |
Accrued – other | |
| 43,517 | | |
| 21,954 | |
Accrued settlement liabilities | |
| 89,330 | | |
| 89,330 | |
Accrued bonuses | |
| - | | |
| 150,000 | |
| |
$ | 132,847 | | |
$ | 261,284 | |
|
X |
- DefinitionThe entire disclosure for accounts payable, accrued expenses, and other liabilities that are classified as current at the end of the reporting period.
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v3.24.3
RELATED PARTY TRANSACTIONS
|
9 Months Ended |
Sep. 30, 2024 |
Related Party Transactions [Abstract] |
|
RELATED PARTY TRANSACTIONS |
NOTE
5 — RELATED PARTY TRANSACTIONS
U.S.
Asian Consulting Group, LLC
On
May 9, 2018, the Company entered into a five-year consulting agreement with U.S. Asian Consulting Group, LLC (“U.S. Asian”).
The consulting agreement was extended for an additional period of eight years upon the closing of our initial public offering. The agreement
was amended effective as of July 1, 2024 to expand the services. The two members of U.S. Asian are shareholders in the Company including
Marilyn Elson who is Nexalin’s Controller.
Pursuant
to the consulting agreement, U.S. Asian provides consulting services to the Company with regard to, among other things, corporate development,
financing arrangements and international operations. The Company was paying U.S. Asian $10,000 per month for services
rendered pursuant to the consulting agreement. The amended agreement calls for a monthly fee of $16,667, a onetime stock grant and a semi-annual
share award equal to $100,000 with the issuance and delivery of shares to take place following the termination of the consulting agreement.
The Company recorded consulting expenses related to the consulting agreement of $110,000 and stock compensation expense of $146,000 for
the nine months ended September 30, 2024 and $90,000 of consulting expenses for the nine months ended September 30, 2023, respectively.
The Company recorded $30,000 related to the consulting agreement for each of the three months ended September 30, 2024 and 2023,
respectively, on the Company’s unaudited condensed consolidated statements of operations and comprehensive loss.
Leonard
Osser was issued 200,000
shares of Company stock as compensation for his services on the Advisory Board. The Company recorded $144,000
and $0
of stock compensation expense for the nine months ended September 30, 2024 and September 30, 2023 respectively.
Officers
On
July 1, 2023, the Company entered into a new employment agreement with Mark White to serve as Chief Executive Officer, a new services
agreement with David Owens, M.D. to serve as Chief Medical Officer and a new employment agreement with Michael Nketiah to serve as Senior
Vice President, Quality, Regulatory and Clinical Affairs. Each of the foregoing agreements are governed by three-year terms and provide
compensation in the form of performance-and service-based stock option awards based on the closing price of the Company’s publicly
traded common stock on the applicable date of grant. On July 29, 2024, Michael Nketiah submitted his resignation effective August 16,
2024.
Effective
September 16, 2024, the Company entered into an agreement with Ms. Carolyn Shelton to serve as Senior Vice President, Quality, Regulatory
and Clinical Affairs.
Under
the terms of his employment agreement, Mr. White is entitled to (i) a sign-on/retention bonus consisting of a one-time lump-sum payment
of $50,000 and a grant of nonqualified stock options to purchase 1,387,024 shares of the Company’s common stock with an exercise
price of $.894 per share subject to certain time and performance-based vesting conditions.
Under
the terms of his service agreement, Dr. Owens is entitled to (i) a sign-on/retention bonus consisting of a grant of nonqualified stock
options to purchase 654,362 shares of the Company’s common stock with an exercise price of $.894 per share subject to certain time
and performance-based vesting conditions.
Under
the terms of his employment agreement Mr. Nketiah was entitled to nonqualified stock option grants to purchase 100,671 shares of the
Company’s common stock with an exercise price of $.894 subject to certain time and performance-based vesting conditions.
Under
the terms of her agreement Ms. Shelton is entitled to nonqualified stock option grants to purchase 90,620 shares of the
Company’s common stock with an exercise price of $.6621, subject to certain time and performance-based vesting conditions.
Such options were not granted as of September 30, 2024.
In
addition to the retention payments, stock awards and nonqualified option grants described above, Messrs. White and Nketiah are receiving
cash compensation and each of Messrs. White and Nketiah are eligible for performance-based cash bonuses. The 2023 performance-based milestones
regarding Mr. White’s incentive compensation have been met for 2023, and he was awarded a cash bonus of $120,000 and 313,199 nonqualified
stock options with a vesting date of July 1, 2024. The 2023 performance-based milestones regarding Mr. Nketiah’s incentive
compensation have been met for 2023, and he was awarded a cash bonus of $50,000 and 33,557 nonqualified stock options with a vesting
date of July 1, 2024.
The
reported amounts are calculated in accordance with the provisions of Financial Accounting Standards Board (“FASB”) Accounting
Standard Codification Topic 718, “Compensation — Stock Compensation (“ASC 718”). ASC 718 focuses primarily on
accounting for transactions in which an entity obtains employee services in share-based payment transactions, such as the options issued
under our 2023 Plan.
Leases
Our
principal executive office is located at 1776 Yorktown, Suite 550, Houston, Texas 77056. Under ASC 842 “Leases”, we
have two separate sub-leases (through IIcom Strategic Inc. controlled and owned by our Chief Executive Officer) totalling approximately
4,000 square feet of office space under operating leases. Management and supporting staff are hosted at this location. Our lease costs
for each of the three months ended September 30, 2024 and 2023 were $13,500 and $13,500. Our lease costs for each of the nine months
ended September 30, 2024 and 2023 were $40,500 and $40,500. The initial sub-leases expired in January of 2024. The Company has entered
into a new one year sublease for 4,000 square feet of office space under an operating lease. Pursuant to the sublease, the Company pays
and will pay the third party landlord (not the sub landlord) all direct and indirect rent costs under the primary lease directly for
the leased premises. No additional payments are made to the Chief Executive Officer or the entity controlled by him.
|
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v3.24.3
STOCKHOLDERS’ EQUITY
|
9 Months Ended |
Sep. 30, 2024 |
Equity [Abstract] |
|
STOCKHOLDERS’ EQUITY |
NOTE
6 — STOCKHOLDERS’ EQUITY
Issuance
of Common Stock
During
the nine months ended September 30, 2024, the Company issued an aggregate of 5,425,043 shares of its common stock, as follows:
| ● | 150,000
shares of common stock were issued to affiliates of Wider in satisfaction of obligations
pursuant to their collaborative agreement. A charge to research and development of $750,000
was recorded in 2023 at the time the Company recognized its obligation to issue these shares. |
| ● | 3,000,000
shares of common stock were issued to investors for net proceeds of $4,516,184. |
| ● | 2,275,043
shares of common stock were issued for services in lieu of cash of which 1,232,357 were issued
to outside consultants, 200,000 to a related party, 542,500 to certain employees
of the Company, and 300,186 to current and former members of the Board of Directors for their
services as Board Members. |
During
the nine months ended September 30, 2023, the Company issued 150,000 shares of its common stock to Wider pursuant to their collaborative
agreement resulting in a charge to research and development of $750,000.
Options
Nexalin’s
2023 Equity Incentive Plan (the “2023 Plan”) was approved by our stockholders on November 10, 2023 and an amendment
thereto, increasing the number of shares reserved for issuance under the 2023 Plan, was approved by our stockholders on August 26,
2024. The 2023 Plan provides that maximum number of shares of Common Stock available for the grant of awards thereunder shall be 6,000,000,
subject to adjustment for stock dividends, stock splits or similar events. The 2023 Plan is administered by the Board of Directors, which
may in turn delegate administrative authority to one or more of our executive officers. Under the terms of the 2023 Plan, the Compensation
Committee may grant equity awards, including nonqualified stock options and restricted stock to employees, officers, directors, consultants,
agents, advisors and independent contractors.
On
July 1, 2023, the Company entered into amended employment agreements with the three executives. In addition to the cash compensation
included in their employment contracts, the three executives were granted one-time bonus stock options (that were immediately vested)
and performance-based stock options that would be triggered based on certain performance criteria being achieved. The amount expensed
during the three months ended September 30, 2024 and 2023 in the unaudited condensed consolidated statements of operations and comprehensive
loss was $0 and $0 respectively. The amount expensed during the nine months ended September 30, 2024 and 2023 in the unaudited condensed
consolidated statements of operations and comprehensive loss was $88,120 and $0 respectively.
Certain
employees and certain members of the Board of Directors were issued options to purchase an aggregate of 581,250 shares of common stock.
The options vested immediately upon grant. The amount expensed during the three months ended September 30, 2024 and 2023 in the
unaudited condensed consolidated statements of operations and comprehensive loss was $434,194 and $0 respectively. The amount expensed
during the nine months ended September 30, 2024 and 2023 in the unaudited condensed consolidated statements of operations
and comprehensive loss was $434,194 and $0 respectively.
The
following table presents a summary of stock option award activity during the nine months ended September 30, 2024:
Schedule of stock option award activity | |
| | | |
| | | |
| | |
| |
Number of
options | | |
Weighted
Average
Exercise Price | | |
Weighted
Average
Remaining
Life In Years | |
Outstanding December 31, 2023 | |
| 2,281,879 | | |
$ | 0.89 | | |
| 8.75 | |
Issued | |
| 581,250 | | |
| 0.94 | | |
| 5.00 | |
Exercised | |
| - | | |
| - | | |
| - | |
Expired or cancelled | |
| - | | |
| - | | |
| - | |
Outstanding September 30, 2024 | |
| 2,863,129 | | |
$ | 0.90 | | |
| 8.27 | |
The
following table provides additional information about stock options that are outstanding and exercisable at September 30, 2024:
| Schedule of additional information about stock options | | |
| | | |
| | | |
| | |
Exercise Price | | |
Outstanding Number of Options | | |
Weighted Average Remaining Life In Years | | |
Exercisable Number of Options | |
$ | 0.89 | | |
| 2,281,879 | | |
$ | 8.75 | | |
| 1,152,125 | |
$ | 0.94 | | |
| 581,250 | | |
| 5.00 | | |
| 581,250 | |
| | | |
| 2,863,129 | | |
$ | 8.27 | | |
| 1,733,375 | |
The
fair value of these stock option awards is estimated as of the grant date using a Black-Scholes option pricing model and the following
assumptions: A risk-free interest rate based on the U.S. Treasury yield curve at the date of grant; an expected or contractual term;
and expected volatility based on an evaluation of comparable public companies’ measures of volatility. The Company does not anticipate
declaring dividends on common shares now or in the near future and has therefore assumed no dividend rate. The following tables disclose
the assumptions, utilized for stock options as follows:
For
the 581,250 stock options granted during the nine months ended September 30, 2024, we used the following weighted average assumptions
to estimate the fair value of stock options:
Schedule of assumptions | |
| | |
| |
September 30,
2024 | |
Volatility | |
| 103.8 | % |
Expected dividends | |
$ | - | |
Risk-free interest rate | |
| 3.66 | % |
Expected term (years) | |
| 5.0 | |
For
the stock options outstanding as of December 31,2023, we used the following weighted average assumptions to estimate the fair value
of stock options:
| |
December 31, 2023 | |
Volatility | |
| 99.0 | % |
Expected dividends | |
$ | - | |
Risk-free interest rate | |
| 4.61 | % |
Expected term (years) | |
| 9.5 | |
Warrants
The
issuance of warrants to purchase shares of the Company’s common stock are summarized as follows:
Schedule of warrants | |
| | | |
| | |
| |
Number of
warrants | | |
Weighted
Average
Exercise Price | |
Outstanding December 31, 2023 | |
| 2,662,250 | | |
$ | 4.15 | |
Issued | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | |
Expired or cancelled | |
| - | | |
| - | |
Outstanding September 30, 2024 | |
| 2,662,250 | | |
$ | 4.15 | |
The
following table summarizes information about warrants to purchase shares of the Company’s common stock outstanding and exercisable
at September 30, 2024:
| Summary information about warrants to purchase | | |
| | | |
| | | |
| | | |
| | |
Exercise Price | | |
Outstanding Number of Warrants | | |
Weighted Average Remaining Life In Years | | |
Weighted Average Exercise Price | | |
Exercisable Number of Warrants | |
$ | 4.15 | | |
| 2,315,000 | | |
| 1.00 | | |
$ | 4.15 | | |
| 2,135,000 | |
$ | 4.15 | | |
| 347,250 | | |
| 1.00 | | |
| 4.15 | | |
| 347,250 | |
| | | |
| 2,662,250 | | |
| 1.00 | | |
$ | 4.15 | | |
| 2,662,250 | |
The
compensation expense attributed to the issuance of the warrants, if required to be recognized on the nature of the transaction, was recognized
as they vested/earned. These warrants are exercisable up to three years from the date of grant. All are currently exercisable.
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v3.24.3
COMMITMENTS AND CONTINGENCIES
|
9 Months Ended |
Sep. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENCIES |
NOTE
7 — COMMITMENTS AND CONTINGENCIES
There
are no material pending legal proceedings in which the Company or any of its subsidiaries is a party or in which any director, officer
or affiliate of the Company, any owner of record or beneficially of more than 5% of any class of its voting securities, or security holder
is a party adverse to us or has a material interest adverse to the Company other than the following:
Sarah
Veltz v. Nexalin Technology, Inc. et al.
Plaintiff,
Sarah Veltz, filed a lawsuit in this matter on January 20, 2021 in Orange County Superior Court (Case No. 30-2021-01180164-CU-WT-CJC)
(the “Complaint”) naming the Company and others as defendants. In her Complaint, Plaintiff contends that she was employed
by defendants, including Nexalin, and has not been paid all wages, including overtime wages and other benefits allegedly due her. Plaintiff
also contends that, during her employment, she was subjected to sexual harassment by the Company’s then Chief Executive Officer.
Plaintiff seeks both compensatory and punitive damages. On March 12, 2021, the Company filed its answer to the Complaint. Although
the parties are seeking mediation, the court has set a trial in this matter for June 9, 2025, with a mediation date not yet set.
Management’s intent is to contest the allegations vigorously and, as of the date of this report, is unable to provide an evaluation
of the potential outcome of the litigation within the probable or remote range or to provide an estimate of the amount of or a range
of potential loss that might be incurred by the Company.
Employment
Development Department
The
Company is currently engaged in settlement discussions with the Employment Development Department (EDD) of the State of California. This
matter involves issues related to our previous management’s classification of certain work provided to or on behalf of the Company’s
business as contract labor instead of employee labor. The total amount involved was approximately $300,000. Management has petitioned
for reassessment and believes the hired workers at issue were indeed actual contractors and not employees. We have no business in California
other than one part time and one full time worker residing in California. The EDD approved a significant downward adjustment in our outstanding
employment tax liability to approximately $40,000 as reflected on its Statement of Account dated November 30, 2023. We plan to further
negotiate with the EDD and proceed with a settlement offer. The Company has accrued $40,000 and $40,000 on the consolidated balance sheets
as of September 30, 2024 and December 31, 2023, respectively. The reduction in the amount accrued was recognized as other income
on the consolidated statement of operations and comprehensive loss for the year ended December 31, 2023. The Company believes it
has adequately accrued for this matter.
Demand
Letter from The University of Arizona
On
December 8, 2022, the Company received a demand letter from the University of Arizona seeking payment of $111,094. The Company and
the University of Arizona agreed on the terms of a settlement for the amounts claimed by the University, whereby the Company paid an
aggregate of approximately $69,000 (in three equal monthly payments) in full satisfaction of amounts the University claims it is owed.
The settlement amount was paid in full as of December 31, 2023.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.3
CONCENTRATION OF CREDIT RISK
|
9 Months Ended |
Sep. 30, 2024 |
Risks and Uncertainties [Abstract] |
|
CONCENTRATION OF CREDIT RISK |
NOTE
8 — CONCENTRATION OF CREDIT RISK
Revenues
Five
customers accounted for 75% of revenues for the three months ended September 30, 2024 and two customers accounted for 59% of revenues
for the nine months ended September 30, 2024, as set forth below:
Concentration of credit risk | |
| | | |
| | |
| |
Three Months Ended September 30,
2024 | | |
Nine Months Ended September 30,
2024 | |
Customer A | |
| 23 | % | |
| 48 | % |
Customer B | |
| 18 | % | |
| 11 | % |
Customer C | |
| 13 | % | |
| - | |
Customer D | |
| 11 | % | |
| - | |
Customer E | |
| 10 | % | |
| - | |
Three
customers accounted for 70% and 55% of revenues for the three and nine months ended September 30, 2023, respectively as set forth
below:
| |
Three Months Ended September 30,
2023 | | |
Nine Months Ended September 30,
2023 | |
Customer A | |
| 27 | % | |
| 24 | % |
Customer B | |
| 23 | % | |
| 18 | % |
Customer C | |
| 20 | % | |
| 13 | % |
Accounts
Receivable
Four
customers accounted for 78% of accounts receivable at September 30, 2024, as set forth below:
Customer A | |
| 43 | % |
Customer B | |
| 18 | % |
Customer C | |
| 17 | % |
Five
customers accounted for 97% of accounts receivable at December 31, 2023.
Customer A - related party | |
| 39 | % |
Customer B | |
| 21 | % |
Customer C | |
| 15 | % |
Customer D | |
| 12 | % |
Customer E | |
| 10 | % |
|
X |
- DefinitionThe entire disclosure for any concentrations existing at the date of the financial statements that make an entity vulnerable to a reasonably possible, near-term, severe impact. This disclosure informs financial statement users about the general nature of the risk associated with the concentration, and may indicate the percentage of concentration risk as of the balance sheet date.
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v3.24.3
SUBSEQUENT EVENTS
|
9 Months Ended |
Sep. 30, 2024 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
9 — SUBSEQUENT EVENTS
On November
7, 2024, the Company entered into stock option agreements with two employees for services in lieu of cash, and two members of the Board
of Directors for their services as Board Members, granting options to purchase an aggregate of 581,250 shares of the Company’s common
stock at an exercise price of $.94 per share. Such stock options were immediately vested.
On November 7, 2024, the Company
entered into a stock option agreement with Michael Nketiah with respect to his July 1, 2023 Employment Agreement. Mr. Nketiah was granted
performance-based stock options to purchase 100,671 shares of common stock at an exercise price of $.894 per share.
On
November 7, 2024, the Company entered into a stock option agreement with Carolyn Shelton. Ms. Shelton was granted performance-based
stock options to purchase up to 90,620
shares of common stock at an exercise price of $.6621
per share that would be triggered based on certain performance criteria being achieved. Such options vest in three equal
portions over the three year period beginning on the first anniversary of her employment date.
On October
28, 2024, the Board of Directors approved the issuance of an aggregate of 363,635 shares of our restricted common stock for services
in lieu of cash, to outside consultants and to Wider, a related party.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NEW ACCOUNTING STANDARDS (Policies)
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with Generally Accepted Accounting
Principles in the United States (“GAAP”). In the opinion of management, such financial information includes all adjustments
(consisting only of normal recurring adjustments) considered necessary for a fair presentation of the Company’s financial position
and the operating results and cash flows. Operating results for the nine months ended September 30, 2024 and 2023 are not necessarily
indicative of the results that may be expected for any other subsequent interim period. Certain information and footnote disclosures
normally included in consolidated financial statements prepared in accordance with GAAP have been omitted pursuant to the rules of the
SEC. These unaudited condensed consolidated financial statements and related notes should be read in conjunction with the Company’s
audited consolidated financial statements for the year ended December 31, 2023.
|
Principles of Consolidation |
Principles
of Consolidation
The
unaudited condensed consolidated financial statements include the accounts of Nexalin and its wholly owned subsidiary Neuro-Health. Intercompany
accounts and transactions have been eliminated in consolidation.
|
Use of Estimates |
Use
of Estimates
The
preparation of the unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates
and assumptions that affect the reported amounts of assets, liabilities, equity-based transactions, revenue and expenses and disclosure
of contingent liabilities at the date of the consolidated financial statements. The Company bases its estimates and assumptions on historical
experience, known or expected trends and various other assumptions that it believes to be reasonable. As future events and their effects
cannot be determined with precision, actual results could differ from these estimates, which may cause the Company’s future results
to be affected.
|
Revenue |
Revenue
The
Company recognizes revenue when its performance obligations with its customers have been satisfied. At contract inception, the Company
determines if the contract is within the scope of Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts
with Customers, and then evaluates the contract using the following five steps: (1) identify the contract with the customer; (2)
identify the performance obligations; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations;
and (5) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only recognizes revenue to the extent
that it is probable that a significant revenue reversal will not occur in a future period.
The
Company has existing licensing and treatment fee agreements with its customers for the use of the Nexalin Device in their practices.
These agreements generally have terms of one year with automatic renewal if certain requirements are met and amounts due per these agreements
are billed monthly. The Company also sells products related to the provision of services. The Company sells its Devices in China to its
acting distributor and sells products relating to the use of the Devices. The Company has a Royalty Agreement whereby the manufacturer
of the Company’s electrodes will pay a royalty to the Company for a three-year period beginning January 1, 2022. The amount
of the Royalty is equal to 20% of the amount that the manufacturer invoices to the acting distributor for the sale of the electrodes.
Revenue
Streams
The
Company derives revenues from our license agreements by charging a monthly licensing fee for the duration of the agreement. The Company
derives revenues from equipment by selling additional individual electrodes to customers for use with the Nexalin Device. We receive
revenue from the sale in China of our Devices to our distributor and from the sale of products relating to the use of those Devices.
We derive revenue as a royalty fee from the China-based manufacturer for electrodes ordered in connection with our China sales.
Disaggregated
Revenues
Major
Revenue Streams
Revenue
consists of the following by service offering:
Schedule of disaggregation of revenue | |
| | | |
| | |
| |
Three Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Device sales | |
$ | - | | |
$ | - | |
Licensing fee | |
| 16,941 | | |
| 18,664 | |
Equipment | |
| 18,802 | | |
| 5,179 | |
Other | |
| 288 | | |
| 270 | |
Total | |
$ | 36,031 | | |
$ | 24,113 | |
| |
Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Device sales | |
$ | 55,500 | | |
$ | 9,600 | |
Licensing fee | |
| 54,561 | | |
| 62,566 | |
Equipment | |
| 30,423 | | |
| 16,679 | |
Other | |
| 1,058 | | |
| 1,367 | |
Total | |
$ | 141,542 | | |
$ | 90,212 | |
Major
Geographic Locations
| |
Three Months Ended
September 30, | |
| |
2024 | | |
2023 | |
U.S. sales | |
$ | 20,664 | | |
$ | 24,113 | |
International sales | |
| 15,367 | | |
| - | |
Total | |
$ | 36,031 | | |
$ | 24,113 | |
| |
Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | |
U.S. sales | |
$ | 65,523 | | |
$ | 80,005 | |
International sales | |
| 76,019 | | |
| 10,207 | |
Total | |
$ | 141,542 | | |
$ | 90,212 | |
|
Cash and Cash Equivalents |
Cash
and Cash Equivalents
The
Company considers all highly liquid investments with maturities of three months or less at the time of purchase to be cash equivalents.
Cash and cash equivalents held at financial institutions may at times exceed insured amounts. The Company believes it mitigates such
risk by investing in or through, as well as maintaining cash balances with, with major financial institutions.
|
Short-Term Investments |
Short-Term
Investments
The
appropriate classification of marketable securities is determined at the time of purchase and evaluated as of each reporting balance
sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair value
is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or
liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the
assets or liabilities. Unrealized holding gains and losses for equity securities are recognized in earnings. Unrealized holding gains
and losses for available for sale debt securities are recognized in other comprehensive income (loss.) Realized gains and losses and
interest and dividends earned are included in other income (expense), net. For individual debt securities classified as available-for-sale
securities, the Company determines whether a decline in fair value below the amortized cost basis has resulted from a credit loss or
other factors. If the decline below amortized cost is a result of credit loss or the Company will more likely than not be required to
sell the security before recovery of its amortized cost basis, the Company will recognize an impairment relating to the decline through
an allowance for credit losses. There were no deemed permanent impairments for the three and nine months ended September 30, 2024
and 2023, respectively.
|
Patents and Trademarks |
Patents
and Trademarks
Patents
and trademarks are amortized over their useful lives and are reviewed for impairment when warranted by economic conditions. Amortization
expense was $10,666 and $2,105 for the nine months ended September 30, 2024 and 2023, respectively. Amortization expense was $4,211
and $753 for the three months ended September 30, 2024 and 2023, respectively.
The
following table summarizes the gross carrying amount, amortization and the net carrying value at September 30, 2024 and December 31,
2023.
Schedule of patents | |
| | | |
| | | |
| | |
| |
Gross Carrying
Amount | | |
Accumulated
Amortization | | |
Net Carrying
Value | |
September 30,
2024 | |
| | | |
| | | |
| | |
Patents | |
$ | 200,906 | | |
$ | (10,680 | ) | |
$ | 190,226 | |
Trademarks | |
| 62,717 | | |
| (4,001 | ) | |
| 58,716 | |
Total September 30, 2024 | |
$ | 263,623 | | |
$ | (14,681 | ) | |
$ | 248,942 | |
| |
| | | |
| | | |
| | |
December 31,
2023 | |
| | | |
| | | |
| | |
Patents | |
$ | 98,970 | | |
$ | (3,751 | ) | |
$ | 95,219 | |
Trademarks | |
| 10,573 | | |
| (264 | ) | |
| 10,309 | |
Total December 31, 2023 | |
$ | 109,543 | | |
$ | (4,015 | ) | |
$ | 105,528 | |
|
Income Taxes |
Income
Taxes
The
Company accounts for income taxes pursuant to the asset and liability method which requires the recognition of deferred income tax assets
and liabilities related to the expected future tax consequences arising from temporary differences between the carrying amounts and tax
bases of assets and liabilities based on enacted statutory tax rates applicable to the periods in which the temporary differences are
expected to reverse. Any effects of changes in income tax rates or laws are included in income tax expense in the period of enactment.
The
Company records valuation allowances against deferred tax assets when it is more likely than not that all or a portion of a deferred
tax asset will not be realized. At September 30, 2024 and December 31, 2023, the Company had a full valuation allowance applied
against its net tax assets.
|
Fair Value Measurements |
Fair
Value Measurements
As
defined in ASC 820, Fair Value Measurements and Disclosures, fair value is the price that would be received to sell an asset or
paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company
utilizes market data or assumptions that market participants would use in pricing the asset or liability, including assumptions about
risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market corroborated, or
generally unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy
gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurement) and
the lowest priority to unobservable inputs (level 3 measurement). This fair value measurement framework applies at both initial and subsequent
measurement.
|
● |
Level 1: Quoted prices
are available in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions
for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. |
|
|
|
|
● |
Level 2: Pricing inputs
are other than quoted prices in active markets included in Level 1, which are either directly or indirectly observable as of the
reported date. Level 2 includes those financial instruments that are valued using models or other valuation methodologies. These
models are primarily industry-standard models that consider various assumptions, including quoted forward prices for commodities,
time value, volatility factors and current market and contractual prices for the underlying instruments, as well as other relevant
economic measures. Substantially all of these assumptions are observable in the marketplace throughout the full term of the instrument,
can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. |
|
|
|
|
● |
Level 3: Pricing inputs
include significant inputs that are generally less observable from objective sources. These inputs may be used with internally developed
methodologies that result in management’s best estimate of fair value. The significant unobservable inputs used in the fair
value measurement for nonrecurring fair value measurements of long-lived assets include pricing models, discounted cash flow methodologies
and similar techniques. |
|
Fair Value of Financial Instruments |
Fair
Value of Financial Instruments
The
carrying value of cash, short-term investments, accounts receivable, inventory, prepaids, accounts payable and accrued expenses, and
other current liabilities approximate their fair values based on the short-term maturity of these instruments. The carrying amount of
the loans payable approximates the estimated fair value for this financial instrument as management believes that such debt and interest
payable on the note approximates the Company’s incremental borrowing rate.
The
following table summarizes the amortized cost, unrealized gain (loss) and the fair value at September 30, 2024 and December 31,
2023.
Schedule of unrealized loss on investments | |
| | | |
| | | |
| | |
| |
Amortized Cost | | |
Unrealized Gain
(Loss) | | |
Fair Value | |
September 30, 2024 | |
| | | |
| | | |
| | |
Short-term investments | |
$ | 4,512,522 | | |
$ | (325 | ) | |
$ | 4,512,197 | |
Total September 30, 2024 | |
$ | 4,512,522 | | |
$ | (325 | ) | |
$ | 4,512,197 | |
| |
| | | |
| | | |
| | |
December 31, 2023 | |
| | | |
| | | |
| | |
Short-term investments | |
$ | 2,368,608 | | |
$ | (405 | ) | |
$ | 2,368,203 | |
Total December 31, 2023 | |
$ | 2,368,608 | | |
$ | (405 | ) | |
$ | 2,368,203 | |
The
following table provides the carrying value and fair value of the Company’s financial assets measured at fair value as of September 30,
2024 and December 31, 2023.
Schedule of fair value, assets measured on recurring basis | |
| | | |
| | | |
| | | |
| | |
| |
Carrying Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
September 30, 2024 | |
| | | |
| | | |
| | | |
| | |
U.S. Treasury Notes | |
$ | 4,512,197 | | |
$ | 4,512,197 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
December 31, 2023 | |
| | | |
| | | |
| | | |
| | |
U.S. Treasury Notes | |
$ | 2,368,203 | | |
$ | 2,368,203 | | |
$ | - | | |
$ | - | |
As
defined in ASC 820, Fair Value Measurements and Disclosures, fair value is the price that would be received to sell an asset or paid
to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company utilizes
market data or assumptions that market participants would use in pricing the asset or liability, including assumptions about risk and
the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market corroborated, or generally
unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives
the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurement) and the
lowest priority to unobservable inputs (level 3 measurement). This fair value measurement framework applies at both initial and subsequent
measurement for the three months ended September 30, 2024 and 2023.
|
Net Loss per Common Share |
Net
Loss per Common Share
The
following table summarizes the securities that would be excluded from the diluted per share calculation because the effect of including
these potential shares was antidilutive due to the Company’s net loss position even though the exercise price could be less than
the most recent fair value of the common shares:
Schedule of antidilutive shares | |
| | | |
| | |
| |
Three Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 2,662,250 | | |
| 2,662,250 | |
Stock options | |
| 2,863,129 | | |
| - | |
Total | |
| 5,525,379 | | |
| 2,662,250 | |
| |
Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 2,662,250 | | |
| 2,662,250 | |
Stock options | |
| 2,863,129 | | |
| - | |
Total | |
| 5,525,379 | | |
| 2,662,250 | |
|
Stock-Based Compensation |
Stock-Based
Compensation
The
Company applies the provisions of ASC 718, Compensation — Stock Compensation (“ASC 718”), which requires the
measurement and recognition of compensation expense for all stock-based awards made to employees, including employee stock options, in
the condensed consolidated statements of operations and comprehensive loss.
For
stock options issued to employees and members of the board of directors for their services, the Company estimates the grant date fair
value of each option using the Black-Scholes option pricing model. The use of the Black-Scholes option pricing model requires management
to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the
expected life of the option, risk-free interest rates and expected dividend yields of the common stock. For awards subject to service-based
vesting conditions, including those with a graded vesting schedule, the Company recognizes stock-based compensation expense equal to
the grant date fair value of stock options on a straight-line basis over the requisite service period, which is generally the vesting
term. Forfeitures are recorded as they are incurred as opposed to being estimated at the time of grant and revised.
Pursuant
to ASU 2018-07 Compensation — Stock Compensation (Topic 718): Improvements to Non-employee Share-Based Payment Accounting, the
Company accounts for stock options and restricted shares issued to non-employees for their services in accordance with ASC 718. The Company
uses valuation methods and assumptions to value the stock options that are in line with the process for valuing employee stock options
noted above.
|
Research and Development |
Research
and Development
Research
and development costs are charged to operations as incurred. For the nine months ended September 30, 2024 and 2023, the Company
recorded $453,643 and $1,842,341, respectively, in selling, general and administrative expenses on the unaudited condensed consolidated
statements of operations and comprehensive loss. For the three months ended September 30, 2024 and 2023, the Company recorded $178,565
and $1,638,508, respectively, in selling, general and administrative expenses on the unaudited condensed consolidated statements of operations
and comprehensive loss.
|
Recent Accounting Pronouncements |
Recent
Accounting Pronouncements
In
August of 2023, the FASB issued ASU 2023-05, Business Combinations—Joint Venture (“JV”) Formations: Recognition and
Initial Measurement. The guidance requires newly formed JVs to apply a new basis of accounting to all of its contributed net assets,
which results in the JV initially measuring its contributed net assets under ASC 805-20, Business Combinations. The new guidance would
be applied prospectively and is effective for all newly formed joint venture entities with a formation date on or after January 1,
2025, with early adoption permitted. The Company is evaluating the accounting and disclosure requirements of this update and does not
expect them to have a material effect on the consolidated financial statements.
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The
ASU expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided
to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description
of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. All disclosure
requirements under ASU 2023-07 are also required for public entities with a single reportable segment. The ASU is effective on a retrospective
basis for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15,
2024. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and disclosures.
In
December of 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, establishes incremental
disaggregation of income tax disclosures pertaining to the effective tax rate reconciliation and income taxes paid. This standard is
effective for fiscal years beginning after December 15, 2024, and requires prospective application with the option to apply it retrospectively.
Early adoption is permitted. The Company is currently evaluating the potential impact of adopting this standard on our disclosures.
All
other newly issued but not yet effective accounting pronouncements have been deemed to be not applicable or immaterial to the Company.
|
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v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NEW ACCOUNTING STANDARDS (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Schedule of disaggregation of revenue |
Schedule of disaggregation of revenue | |
| | | |
| | |
| |
Three Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Device sales | |
$ | - | | |
$ | - | |
Licensing fee | |
| 16,941 | | |
| 18,664 | |
Equipment | |
| 18,802 | | |
| 5,179 | |
Other | |
| 288 | | |
| 270 | |
Total | |
$ | 36,031 | | |
$ | 24,113 | |
| |
Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Device sales | |
$ | 55,500 | | |
$ | 9,600 | |
Licensing fee | |
| 54,561 | | |
| 62,566 | |
Equipment | |
| 30,423 | | |
| 16,679 | |
Other | |
| 1,058 | | |
| 1,367 | |
Total | |
$ | 141,542 | | |
$ | 90,212 | |
Major
Geographic Locations
| |
Three Months Ended
September 30, | |
| |
2024 | | |
2023 | |
U.S. sales | |
$ | 20,664 | | |
$ | 24,113 | |
International sales | |
| 15,367 | | |
| - | |
Total | |
$ | 36,031 | | |
$ | 24,113 | |
| |
Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | |
U.S. sales | |
$ | 65,523 | | |
$ | 80,005 | |
International sales | |
| 76,019 | | |
| 10,207 | |
Total | |
$ | 141,542 | | |
$ | 90,212 | |
|
Schedule of patents |
Schedule of patents | |
| | | |
| | | |
| | |
| |
Gross Carrying
Amount | | |
Accumulated
Amortization | | |
Net Carrying
Value | |
September 30,
2024 | |
| | | |
| | | |
| | |
Patents | |
$ | 200,906 | | |
$ | (10,680 | ) | |
$ | 190,226 | |
Trademarks | |
| 62,717 | | |
| (4,001 | ) | |
| 58,716 | |
Total September 30, 2024 | |
$ | 263,623 | | |
$ | (14,681 | ) | |
$ | 248,942 | |
| |
| | | |
| | | |
| | |
December 31,
2023 | |
| | | |
| | | |
| | |
Patents | |
$ | 98,970 | | |
$ | (3,751 | ) | |
$ | 95,219 | |
Trademarks | |
| 10,573 | | |
| (264 | ) | |
| 10,309 | |
Total December 31, 2023 | |
$ | 109,543 | | |
$ | (4,015 | ) | |
$ | 105,528 | |
|
Schedule of unrealized loss on investments |
Schedule of unrealized loss on investments | |
| | | |
| | | |
| | |
| |
Amortized Cost | | |
Unrealized Gain
(Loss) | | |
Fair Value | |
September 30, 2024 | |
| | | |
| | | |
| | |
Short-term investments | |
$ | 4,512,522 | | |
$ | (325 | ) | |
$ | 4,512,197 | |
Total September 30, 2024 | |
$ | 4,512,522 | | |
$ | (325 | ) | |
$ | 4,512,197 | |
| |
| | | |
| | | |
| | |
December 31, 2023 | |
| | | |
| | | |
| | |
Short-term investments | |
$ | 2,368,608 | | |
$ | (405 | ) | |
$ | 2,368,203 | |
Total December 31, 2023 | |
$ | 2,368,608 | | |
$ | (405 | ) | |
$ | 2,368,203 | |
|
Schedule of fair value, assets measured on recurring basis |
Schedule of fair value, assets measured on recurring basis | |
| | | |
| | | |
| | | |
| | |
| |
Carrying Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
September 30, 2024 | |
| | | |
| | | |
| | | |
| | |
U.S. Treasury Notes | |
$ | 4,512,197 | | |
$ | 4,512,197 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
December 31, 2023 | |
| | | |
| | | |
| | | |
| | |
U.S. Treasury Notes | |
$ | 2,368,203 | | |
$ | 2,368,203 | | |
$ | - | | |
$ | - | |
|
Schedule of antidilutive shares |
Schedule of antidilutive shares | |
| | | |
| | |
| |
Three Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 2,662,250 | | |
| 2,662,250 | |
Stock options | |
| 2,863,129 | | |
| - | |
Total | |
| 5,525,379 | | |
| 2,662,250 | |
| |
Nine Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Warrants | |
| 2,662,250 | | |
| 2,662,250 | |
Stock options | |
| 2,863,129 | | |
| - | |
Total | |
| 5,525,379 | | |
| 2,662,250 | |
|
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v3.24.3
ACCRUED EXPENSES (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Payables and Accruals [Abstract] |
|
Schedule of accrued expenses |
Schedule of accrued expenses | |
| | | |
| | |
| |
September 30,
2024 | | |
December 31,
2023 | |
Accrued – other | |
| 43,517 | | |
| 21,954 | |
Accrued settlement liabilities | |
| 89,330 | | |
| 89,330 | |
Accrued bonuses | |
| - | | |
| 150,000 | |
| |
$ | 132,847 | | |
$ | 261,284 | |
|
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v3.24.3
STOCKHOLDERS’ EQUITY (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Equity [Abstract] |
|
Schedule of stock option award activity |
Schedule of stock option award activity | |
| | | |
| | | |
| | |
| |
Number of
options | | |
Weighted
Average
Exercise Price | | |
Weighted
Average
Remaining
Life In Years | |
Outstanding December 31, 2023 | |
| 2,281,879 | | |
$ | 0.89 | | |
| 8.75 | |
Issued | |
| 581,250 | | |
| 0.94 | | |
| 5.00 | |
Exercised | |
| - | | |
| - | | |
| - | |
Expired or cancelled | |
| - | | |
| - | | |
| - | |
Outstanding September 30, 2024 | |
| 2,863,129 | | |
$ | 0.90 | | |
| 8.27 | |
|
Schedule of additional information about stock options |
| Schedule of additional information about stock options | | |
| | | |
| | | |
| | |
Exercise Price | | |
Outstanding Number of Options | | |
Weighted Average Remaining Life In Years | | |
Exercisable Number of Options | |
$ | 0.89 | | |
| 2,281,879 | | |
$ | 8.75 | | |
| 1,152,125 | |
$ | 0.94 | | |
| 581,250 | | |
| 5.00 | | |
| 581,250 | |
| | | |
| 2,863,129 | | |
$ | 8.27 | | |
| 1,733,375 | |
|
Schedule of assumptions |
Schedule of assumptions | |
| | |
| |
September 30,
2024 | |
Volatility | |
| 103.8 | % |
Expected dividends | |
$ | - | |
Risk-free interest rate | |
| 3.66 | % |
Expected term (years) | |
| 5.0 | |
For
the stock options outstanding as of December 31,2023, we used the following weighted average assumptions to estimate the fair value
of stock options:
| |
December 31, 2023 | |
Volatility | |
| 99.0 | % |
Expected dividends | |
$ | - | |
Risk-free interest rate | |
| 4.61 | % |
Expected term (years) | |
| 9.5 | |
|
Schedule of warrants |
Schedule of warrants | |
| | | |
| | |
| |
Number of
warrants | | |
Weighted
Average
Exercise Price | |
Outstanding December 31, 2023 | |
| 2,662,250 | | |
$ | 4.15 | |
Issued | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | |
Expired or cancelled | |
| - | | |
| - | |
Outstanding September 30, 2024 | |
| 2,662,250 | | |
$ | 4.15 | |
|
Summary information about warrants to purchase |
| Summary information about warrants to purchase | | |
| | | |
| | | |
| | | |
| | |
Exercise Price | | |
Outstanding Number of Warrants | | |
Weighted Average Remaining Life In Years | | |
Weighted Average Exercise Price | | |
Exercisable Number of Warrants | |
$ | 4.15 | | |
| 2,315,000 | | |
| 1.00 | | |
$ | 4.15 | | |
| 2,135,000 | |
$ | 4.15 | | |
| 347,250 | | |
| 1.00 | | |
| 4.15 | | |
| 347,250 | |
| | | |
| 2,662,250 | | |
| 1.00 | | |
$ | 4.15 | | |
| 2,662,250 | |
|
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v3.24.3
CONCENTRATION OF CREDIT RISK (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Risks and Uncertainties [Abstract] |
|
Concentration of credit risk |
Concentration of credit risk | |
| | | |
| | |
| |
Three Months Ended September 30,
2024 | | |
Nine Months Ended September 30,
2024 | |
Customer A | |
| 23 | % | |
| 48 | % |
Customer B | |
| 18 | % | |
| 11 | % |
Customer C | |
| 13 | % | |
| - | |
Customer D | |
| 11 | % | |
| - | |
Customer E | |
| 10 | % | |
| - | |
Three
customers accounted for 70% and 55% of revenues for the three and nine months ended September 30, 2023, respectively as set forth
below:
| |
Three Months Ended September 30,
2023 | | |
Nine Months Ended September 30,
2023 | |
Customer A | |
| 27 | % | |
| 24 | % |
Customer B | |
| 23 | % | |
| 18 | % |
Customer C | |
| 20 | % | |
| 13 | % |
Accounts
Receivable
Four
customers accounted for 78% of accounts receivable at September 30, 2024, as set forth below:
Customer A | |
| 43 | % |
Customer B | |
| 18 | % |
Customer C | |
| 17 | % |
Five
customers accounted for 97% of accounts receivable at December 31, 2023.
Customer A - related party | |
| 39 | % |
Customer B | |
| 21 | % |
Customer C | |
| 15 | % |
Customer D | |
| 12 | % |
Customer E | |
| 10 | % |
|
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v3.24.3
NATURE OF THE ORGANIZATION AND BUSINESS (Details Narrative) - USD ($)
|
|
|
3 Months Ended |
9 Months Ended |
|
Jul. 03, 2024 |
Jul. 02, 2024 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Equity method investment income |
|
|
$ 159
|
$ 0
|
$ 4,651
|
$ 0
|
|
Equity method investment |
|
|
100,651
|
|
100,651
|
|
$ 96,000
|
Investment |
|
|
|
$ 96,000
|
|
$ 96,000
|
|
Wider Come Limited [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Equity method investment |
|
|
$ 104,000
|
|
$ 104,000
|
|
|
Wider [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Ownership percentage |
|
|
52.00%
|
|
52.00%
|
|
|
Nexalin [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Ownership percentage |
|
|
48.00%
|
|
48.00%
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Shares issued during the period |
3,000,000
|
3,000,000
|
|
|
|
|
|
Share price |
|
$ 1.75
|
|
|
|
|
|
Proceeds from issuance of equity |
$ 5,250,000
|
$ 4,720,000
|
|
|
|
|
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v3.24.3
LIQUIDITY (Details Narrative) - USD ($)
|
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
|
|
|
Accumulated deficit |
$ (81,811,956)
|
|
$ (81,811,956)
|
|
$ (77,038,049)
|
Loss from operation |
(2,508,517)
|
$ (2,415,537)
|
(4,879,250)
|
$ (4,071,823)
|
|
Cash flows from operations |
|
|
(2,809,914)
|
$ (2,831,354)
|
|
Working capital deficit |
$ 4,600,000
|
|
$ 4,600,000
|
|
|
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v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NEW ACCOUNTING STANDARDS (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Product Information [Line Items] |
|
|
|
|
Total |
$ 36,031
|
$ 24,113
|
$ 141,542
|
$ 90,212
|
UNITED STATES |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Total |
20,664
|
24,113
|
65,523
|
80,005
|
International Sales [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Total |
15,367
|
|
76,019
|
10,207
|
Device Sales [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Total |
|
|
55,500
|
9,600
|
Licensing Fee [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Total |
16,941
|
18,664
|
54,561
|
62,566
|
Equipment [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Total |
18,802
|
5,179
|
30,423
|
16,679
|
Other [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Total |
$ 288
|
$ 270
|
$ 1,058
|
$ 1,367
|
X |
- DefinitionAmount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss).
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v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NEW ACCOUNTING STANDARDS (Details 1) - USD ($)
|
Sep. 30, 2024 |
Dec. 31, 2023 |
Finite-Lived Intangible Assets [Line Items] |
|
|
Carrying Amount |
$ 263,623
|
$ 109,543
|
Accumulated Amortization |
(14,681)
|
(4,015)
|
Net Carring Value |
248,942
|
105,528
|
Patents [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Carrying Amount |
200,906
|
98,970
|
Accumulated Amortization |
(10,680)
|
(3,751)
|
Net Carring Value |
190,226
|
95,219
|
Trademarks [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Carrying Amount |
62,717
|
10,573
|
Accumulated Amortization |
(4,001)
|
(264)
|
Net Carring Value |
$ 58,716
|
$ 10,309
|
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v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NEW ACCOUNTING STANDARDS (Details 2) - USD ($)
|
9 Months Ended |
12 Months Ended |
Sep. 30, 2024 |
Dec. 31, 2023 |
Schedule of Investments [Line Items] |
|
|
Amortized Cost |
$ 4,512,522
|
$ 2,368,608
|
Unrealized Gain (Loss) |
(325)
|
(405)
|
Fair Value |
4,512,197
|
2,368,203
|
Short-Term Investments [Member] |
|
|
Schedule of Investments [Line Items] |
|
|
Amortized Cost |
4,512,522
|
2,368,608
|
Unrealized Gain (Loss) |
(325)
|
(405)
|
Fair Value |
$ 4,512,197
|
$ 2,368,203
|
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v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NEW ACCOUNTING STANDARDS (Details 3) - USD ($)
|
Sep. 30, 2024 |
Dec. 31, 2023 |
Platform Operator, Crypto Asset [Line Items] |
|
|
Financial assets |
$ 4,512,197
|
$ 2,368,203
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Platform Operator, Crypto Asset [Line Items] |
|
|
Financial assets |
4,512,197
|
2,368,203
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Platform Operator, Crypto Asset [Line Items] |
|
|
Financial assets |
|
|
Fair Value, Inputs, Level 3 [Member] |
|
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|
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|
|
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v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NEW ACCOUNTING STANDARDS (Details 4) - shares
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
5,525,379
|
2,662,250
|
5,525,379
|
2,662,250
|
Warrant [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
2,662,250
|
2,662,250
|
2,662,250
|
2,662,250
|
Equity Option [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
2,863,129
|
|
2,863,129
|
|
X |
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v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND NEW ACCOUNTING STANDARDS (Details Narrative) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
|
|
|
Amortization expense |
$ 4,211
|
$ 753
|
$ 10,666
|
$ 2,105
|
Research and development costs |
$ 178,565
|
$ 1,638,508
|
$ 453,643
|
$ 1,842,341
|
X |
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v3.24.3
RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($)
|
|
|
3 Months Ended |
9 Months Ended |
Jul. 02, 2023 |
May 09, 2018 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Related Party Transaction [Line Items] |
|
|
|
|
|
|
Stock compensation expense |
|
|
|
|
$ 2,008,801
|
$ 1,661,558
|
Shares issued for services |
|
|
|
|
5,425,043
|
|
Lease payments |
|
|
$ 13,500
|
$ 13,500
|
$ 40,500
|
40,500
|
2023 Plan [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
New service agreement description |
In
addition to the retention payments, stock awards and nonqualified option grants described above, Messrs. White and Nketiah are receiving
cash compensation and each of Messrs. White and Nketiah are eligible for performance-based cash bonuses. The 2023 performance-based milestones
regarding Mr. White’s incentive compensation have been met for 2023, and he was awarded a cash bonus of $120,000 and 313,199 nonqualified
stock options with a vesting date of July 1, 2024. The 2023 performance-based milestones regarding Mr. Nketiah’s incentive
compensation have been met for 2023, and he was awarded a cash bonus of $50,000 and 33,557 nonqualified stock options with a vesting
date of July 1, 2024.
|
|
|
|
|
|
Mr. White [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
New service agreement description |
Under
the terms of his employment agreement, Mr. White is entitled to (i) a sign-on/retention bonus consisting of a one-time lump-sum payment
of $50,000 and a grant of nonqualified stock options to purchase 1,387,024 shares of the Company’s common stock with an exercise
price of $.894 per share subject to certain time and performance-based vesting conditions.
|
|
|
|
|
|
Dr. Owens [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
New service agreement description |
Under
the terms of his service agreement, Dr. Owens is entitled to (i) a sign-on/retention bonus consisting of a grant of nonqualified stock
options to purchase 654,362 shares of the Company’s common stock with an exercise price of $.894 per share subject to certain time
and performance-based vesting conditions.
|
|
|
|
|
|
Mr. Nketiah [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
New service agreement description |
Under
the terms of his employment agreement Mr. Nketiah was entitled to nonqualified stock option grants to purchase 100,671 shares of the
Company’s common stock with an exercise price of $.894 subject to certain time and performance-based vesting conditions.
|
|
|
|
|
|
Ms. Shelton [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
New service agreement description |
Under
the terms of her agreement Ms. Shelton is entitled to nonqualified stock option grants to purchase 90,620 shares of the
Company’s common stock with an exercise price of $.6621, subject to certain time and performance-based vesting conditions.
|
|
|
|
|
|
U.S. Asian Consulting Group, LLC [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
Consulting expenses |
|
|
$ 30,000
|
$ 30,000
|
110,000
|
90,000
|
Stock compensation expense |
|
|
|
|
146,000
|
|
U.S. Asian Consulting Group, LLC [Member] | Leonard Osser [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
Stock compensation expense |
|
|
|
|
$ 144,000
|
$ 0
|
Shares issued for services |
|
|
|
|
200,000
|
|
U.S. Asian Consulting Group, LLC [Member] | Consulting Agreement [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
Monthly payment |
|
$ 10,000
|
|
|
|
|
U.S. Asian Consulting Group, LLC [Member] | Amended Agreement [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
Monthly payment |
|
16,667
|
|
|
|
|
Shares issued values |
|
$ 100,000
|
|
|
|
|
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v3.24.3
STOCKHOLDERS' EQUITY (Details) - $ / shares
|
9 Months Ended |
12 Months Ended |
Sep. 30, 2024 |
Dec. 31, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Weighted Average Remaining Life In years |
8 years 3 months 7 days
|
|
Number of Options Exercised |
|
|
Number of Options Outstanding, Ending Balance |
2,863,129
|
|
Equity Option [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Number of Options Outstanding, Beginning Balance |
2,281,879
|
|
Weighted Average Exercise Price, Options outstanding Beginning Balance |
$ 0.89
|
|
Weighted Average Remaining Life In years |
8 years 3 months 7 days
|
8 years 9 months
|
Number of Options Issued |
581,250
|
|
Weighted Average Exercise Price, Options Issued |
$ 0.94
|
|
Weighted Average Remaining Life In years Issued |
5 years
|
|
Number of Options Exercised |
|
|
Weighted Average Exercise Price, Options Exercised |
|
|
Number of Options Expired or cancelled |
|
|
Weighted Average Exercise Price, Options Expired or cancelled |
|
|
Number of Options Outstanding, Ending Balance |
2,863,129
|
2,281,879
|
Weighted Average Exercise Price, Options outstanding Ending Balance |
$ 0.90
|
$ 0.89
|
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v3.24.3
STOCKHOLDERS' EQUITY (Details 1)
|
9 Months Ended |
Sep. 30, 2024
$ / shares
shares
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Outstanding Number of Options |
2,863,129
|
Weighted Average Remaining Life In Years |
8 years 3 months 7 days
|
Exercisable Number of Options |
1,733,375
|
0.89 |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Price | $ / shares |
$ 0.89
|
Outstanding Number of Options |
2,281,879
|
Weighted Average Remaining Life In Years |
8 years 9 months
|
Exercisable Number of Options |
1,152,125
|
0.94 |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Price | $ / shares |
$ 0.94
|
Outstanding Number of Options |
581,250
|
Weighted Average Remaining Life In Years |
5 years
|
Exercisable Number of Options |
581,250
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STOCKHOLDERS' EQUITY (Details 3)
|
9 Months Ended |
Sep. 30, 2024
$ / shares
shares
|
Equity [Abstract] |
|
Number of Warrants Outstanding at beginning | shares |
2,662,250
|
Weighted Average Exercise Price, Warrants Outstanding at beginning | $ / shares |
$ 4.15
|
Warrants Issued | shares |
|
Weighted Average Exercise Price, Warrants Issued | $ / shares |
|
Warrants Exercised | shares |
|
Weighted Average Exercise Price, Warrants Exercised | $ / shares |
|
Warrants Expired or cancelled | shares |
|
Weighted Average Exercise Price, Warrants Expired or cancelled | $ / shares |
|
Number of Warrants Outstanding at end | shares |
2,662,250
|
Weighted Average Exercise Price, Warrants Outstanding at end | $ / shares |
$ 4.15
|
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v3.24.3
STOCKHOLDERS' EQUITY (Details 4) - $ / shares
|
9 Months Ended |
|
Sep. 30, 2024 |
Dec. 31, 2023 |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
|
Exercise Price |
$ 4.15
|
$ 4.15
|
Outstanding Number of Warrants |
2,662,250
|
2,662,250
|
Weighted Average Remaining Life In Years |
1 year
|
|
Weighted Average Exercise Price |
$ 4.15
|
|
Exercisable Number of Warrants |
2,662,250
|
|
4.15 |
|
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
|
Exercise Price |
$ 4.15
|
|
Outstanding Number of Warrants |
2,315,000
|
|
Weighted Average Remaining Life In Years |
1 year
|
|
Weighted Average Exercise Price |
$ 4.15
|
|
Exercisable Number of Warrants |
2,135,000
|
|
4.15 |
|
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
|
Exercise Price |
$ 4.15
|
|
Outstanding Number of Warrants |
347,250
|
|
Weighted Average Remaining Life In Years |
1 year
|
|
Weighted Average Exercise Price |
$ 4.15
|
|
Exercisable Number of Warrants |
347,250
|
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v3.24.3
STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Issuance of Common Stock |
|
|
5,425,043
|
|
Research and development charges |
$ 178,565
|
$ 1,638,508
|
$ 453,643
|
$ 1,842,341
|
Share based compensation |
0
|
0
|
88,120
|
0
|
Comprehensive loss |
(2,448,582)
|
(2,329,478)
|
(4,773,827)
|
(3,903,553)
|
Board of Directors Chairman [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Comprehensive loss |
$ 434,194
|
$ 0
|
$ 434,194
|
$ 0
|
Affiliates Of Wider [Member] | Investors [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Shhares issued |
|
|
|
3,000,000
|
Shares issued price |
|
|
|
$ 4,516,184
|
Affiliates Of Wider [Member] | Liu [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Issuance of Common Stock |
|
|
|
2,275,043
|
Number of stock issued |
|
|
|
1,232,357
|
Affiliates Of Wider [Member] | Collaborative Agreement [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Issuance of Common Stock |
|
|
150,000
|
|
Shhares issued |
|
|
|
150,000
|
Research and development charges |
|
|
|
$ 750,000
|
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v3.24.3
COMMITMENTS AND CONTINGENCIES (Details Narrative)
|
9 Months Ended |
Sep. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Accrued expenses description |
The Company has accrued $40,000 and $40,000 on the consolidated balance sheets
as of September 30, 2024 and December 31, 2023, respectively. The reduction in the amount accrued was recognized as other income
on the consolidated statement of operations and comprehensive loss for the year ended December 31, 2023. The Company believes it
has adequately accrued for this matter.
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v3.24.3
CONCENTRATION OF CREDIT RISK (Details) - Customer Concentration Risk [Member]
|
3 Months Ended |
9 Months Ended |
12 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Revenue Benchmark [Member] | Customer A [Member] |
|
|
|
|
|
Concentration Risk [Line Items] |
|
|
|
|
|
Revenue, percentage |
23.00%
|
27.00%
|
48.00%
|
24.00%
|
|
Revenue Benchmark [Member] | Customer B [Member] |
|
|
|
|
|
Concentration Risk [Line Items] |
|
|
|
|
|
Revenue, percentage |
18.00%
|
23.00%
|
11.00%
|
18.00%
|
|
Revenue Benchmark [Member] | Customer C [Member] |
|
|
|
|
|
Concentration Risk [Line Items] |
|
|
|
|
|
Revenue, percentage |
13.00%
|
20.00%
|
|
13.00%
|
|
Revenue Benchmark [Member] | Customer D [Member] |
|
|
|
|
|
Concentration Risk [Line Items] |
|
|
|
|
|
Revenue, percentage |
11.00%
|
|
|
|
|
Revenue Benchmark [Member] | Customer E [Member] |
|
|
|
|
|
Concentration Risk [Line Items] |
|
|
|
|
|
Revenue, percentage |
10.00%
|
|
|
|
|
Accounts Receivable [Member] | Customer A [Member] |
|
|
|
|
|
Concentration Risk [Line Items] |
|
|
|
|
|
Revenue, percentage |
|
|
43.00%
|
|
39.00%
|
Accounts Receivable [Member] | Customer B [Member] |
|
|
|
|
|
Concentration Risk [Line Items] |
|
|
|
|
|
Revenue, percentage |
|
|
18.00%
|
|
21.00%
|
Accounts Receivable [Member] | Customer C [Member] |
|
|
|
|
|
Concentration Risk [Line Items] |
|
|
|
|
|
Revenue, percentage |
|
|
17.00%
|
|
15.00%
|
Accounts Receivable [Member] | Customer D [Member] |
|
|
|
|
|
Concentration Risk [Line Items] |
|
|
|
|
|
Revenue, percentage |
|
|
|
|
12.00%
|
Accounts Receivable [Member] | Customer E [Member] |
|
|
|
|
|
Concentration Risk [Line Items] |
|
|
|
|
|
Revenue, percentage |
|
|
|
|
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v3.24.3
CONCENTRATION OF CREDIT RISK (Details Narrative) - Customer Concentration Risk [Member]
|
3 Months Ended |
9 Months Ended |
12 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Revenue Benchmark [Member] | One Customers [Member] |
|
|
|
|
|
Concentration Risk [Line Items] |
|
|
|
|
|
Revenue, percentage |
75.00%
|
|
|
|
|
Revenue Benchmark [Member] | Two Customers [Member] |
|
|
|
|
|
Concentration Risk [Line Items] |
|
|
|
|
|
Revenue, percentage |
|
|
59.00%
|
|
|
Revenue Benchmark [Member] | Three Customers [Member] |
|
|
|
|
|
Concentration Risk [Line Items] |
|
|
|
|
|
Revenue, percentage |
|
70.00%
|
|
55.00%
|
|
Accounts Receivable [Member] | Four Customers [Member] |
|
|
|
|
|
Concentration Risk [Line Items] |
|
|
|
|
|
Revenue, percentage |
|
|
78.00%
|
|
|
Accounts Receivable [Member] | Five Customers [Member] |
|
|
|
|
|
Concentration Risk [Line Items] |
|
|
|
|
|
Revenue, percentage |
|
|
|
|
97.00%
|
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