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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 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 001-41775
NEURAXIS,
INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
45-5079684 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(I.
R. S. Employer
Identification
No.) |
11611
N. Meridian Street, Suite 330
Carmel,
IN |
|
46032 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(812)
689-0791
(Registrant’s
telephone number, including area code)
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 |
|
NRXS |
|
NYSE
American LLC |
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 every Interactive Data File required to be submitted 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, a 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 to Section 7(a)(2)(B) of the Securities Act.
Indicate
by check mark whether the registrant is a shell company (as defined in rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The
number of shares of the registrant’s common stock outstanding as of August 8, 2024 was 6,841,621 shares.
TABLE
OF CONTENTS
PART
I
ITEM
1. FINANCIAL STATEMENTS
NeurAxis,
Inc.
Condensed
Balance Sheets
| |
June 30, 2024 | | |
December 31, | |
| |
(Unaudited) | | |
2023 | |
Assets | |
| | | |
| | |
| |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 1,765,274 | | |
$ | 78,560 | |
Accounts receivable, net | |
| 147,131 | | |
| 73,167 | |
Inventories | |
| 42,710 | | |
| 21,220 | |
Prepaids and other current assets | |
| 156,446 | | |
| 69,663 | |
Total current assets | |
| 2,111,561 | | |
| 242,610 | |
| |
| | | |
| | |
Property and Equipment, at cost: | |
| 460,034 | | |
| 436,626 | |
Less - accumulated depreciation | |
| (364,538 | ) | |
| (348,074 | ) |
Property and equipment, net | |
| 95,496 | | |
| 88,552 | |
| |
| | | |
| | |
Other Assets: | |
| | | |
| | |
Operating lease right of use asset, net | |
| 323,450 | | |
| 70,263 | |
Intangible assets, net | |
| 102,831 | | |
| 108,073 | |
Total Assets | |
$ | 2,633,338 | | |
$ | 509,498 | |
| |
| | | |
| | |
Liabilities | |
| | | |
| | |
| |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 1,118,317 | | |
$ | 1,204,219 | |
Accrued expenses | |
| 1,310,792 | | |
| 401,088 | |
Current portion of operating lease payable | |
| 48,247 | | |
| 49,127 | |
Notes payable | |
| 38,797 | | |
| 148,062 | |
Notes payable - convertible notes, net of unamortized debt discount of $206,464
and $0
as of June 30, 2024 and December 31, 2023, respectively | |
| 4,728,538 | | |
| — | |
Customer deposits | |
| 82,122 | | |
| 74,947 | |
Share liability | |
| 257,131 | | |
| — | |
Warrant liabilities | |
| 9,933 | | |
| 8,225 | |
Total current liabilities | |
| 7,593,877 | | |
| 1,885,668 | |
| |
| | | |
| | |
Non-current Liabilities: | |
| | | |
| | |
Operating lease payable, net of current portion | |
| 297,843 | | |
| 27,071 | |
Total non-current liabilities | |
| 297,843 | | |
| 27,071 | |
| |
| | | |
| | |
Total liabilities | |
| 7,891,720 | | |
| 1,912,739 | |
| |
| | | |
| | |
Commitments and contingencies (see note 12) | |
| - | | |
| - | |
| |
| | | |
| | |
Stockholders’ Deficit | |
| | | |
| | |
Convertible Series A Preferred stock, $0.001 par value; 1,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | |
| — | | |
| — | |
Convertible Series Seed Preferred stock, $0.001 par value; 120,000 shares authorized; 0 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | |
| — | | |
| — | |
Preferred stock, value | |
| — | | |
| — | |
| |
| | | |
| | |
Common stock, $0.001 par value; 100,000,000 shares authorized; 6,841,621 and 6,508,897 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | |
| 6,842 | | |
| 6,509 | |
Additional paid in capital | |
| 48,331,248 | | |
| 47,148,361 | |
Accumulated deficit | |
| (53,596,472 | ) | |
| (48,558,111 | ) |
| |
| | | |
| | |
Total Stockholders’ Deficit | |
| (5,258,382 | ) | |
| (1,403,241 | ) |
| |
| | | |
| | |
Total Liabilities and Stockholders’ Deficit | |
$ | 2,633,338 | | |
$ | 509,498 | |
The
accompanying notes are an integral part of these unaudited condensed financial statements
NeurAxis,
Inc.
Condensed
Statements of Operations (Unaudited)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended
June 30, | | |
For the Six Months Ended
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Net Sales | |
$ | 611,500 | | |
$ | 646,021 | | |
$ | 1,258,135 | | |
$ | 1,451,131 | |
Cost of Goods Sold | |
| 73,458 | | |
| 67,813 | | |
| 148,539 | | |
| 163,713 | |
| |
| | | |
| | | |
| | | |
| | |
Gross Profit | |
| 538,042 | | |
| 578,208 | | |
| 1,109,596 | | |
| 1,287,418 | |
| |
| | | |
| | | |
| | | |
| | |
Selling Expenses | |
| 62,274 | | |
| 78,791 | | |
| 142,304 | | |
| 186,723 | |
Research and Development | |
| 54,312 | | |
| 109,789 | | |
| 59,882 | | |
| 126,586 | |
General and Administrative | |
| 2,628,288 | | |
| 1,507,169 | | |
| 4,946,362 | | |
| 2,987,923 | |
| |
| | | |
| | | |
| | | |
| | |
Operating Loss | |
| (2,206,832 | ) | |
| (1,117,541 | ) | |
| (4,038,952 | ) | |
| (2,013,814 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other (Expense) Income: | |
| | | |
| | | |
| | | |
| | |
Financing charges | |
| — | | |
| — | | |
| (230,824 | ) | |
| (2,772 | ) |
Interest expense | |
| (80,697 | ) | |
| (194,690 | ) | |
| (107,257 | ) | |
| (356,378 | ) |
Change in fair value of warrant liability | |
| 7,576 | | |
| (36,050 | ) | |
| (1,708 | ) | |
| 198,757 | |
Change in fair value of derivative liability | |
| — | | |
| 860 | | |
| — | | |
| 192,157 | |
Amortization of debt discount and issuance cost | |
| (63,817 | ) | |
| (887,937 | ) | |
| (85,500 | ) | |
| (3,550,592 | ) |
Extinguishment of debt liabilities | |
| — | | |
| — | | |
| — | | |
| 1,129,498 | |
Other income | |
| 2,961 | | |
| 2 | | |
| 2,961 | | |
| 1,552 | |
Other expense | |
| (576,901 | ) | |
| (258 | ) | |
| (577,081 | ) | |
| (7,430 | ) |
Total other (expense) income, net | |
| (710,878 | ) | |
| (1,118,073 | ) | |
| (999,409 | ) | |
| (2,395,208 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net Loss | |
$ | (2,917,710 | ) | |
$ | (2,235,614 | ) | |
$ | (5,038,361 | ) | |
$ | (4,409,022 | ) |
| |
| | | |
| | | |
| | | |
| | |
Per-Share Data | |
| | | |
| | | |
| | | |
| | |
Basic and diluted loss per share | |
$ | (0.42 | ) | |
$ | (1.21 | ) | |
$ | (0.73 | ) | |
$ | (2.39 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted Average Shares Outstanding | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
| 6,921,004 | | |
| 2,003,322 | | |
| 6,902,841 | | |
| 2,003,322 | |
The
accompanying notes are an integral part of these unaudited condensed financial statements
NeurAxis,
Inc.
Condensed
Statements of Stockholders’ Deficit (Unaudited)
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
in Capital | | |
Deficit | | |
Deficit | |
|
|
For the Three and Six Months Ended June 30, 2023 |
| |
Convertible Series A Preferred Stock | | |
Convertible Series Seed Preferred Stock | | |
Common Stock | | |
Additional Paid | | |
Accumulated | | |
Stockholder’s | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
In Capital | | |
Deficit | | |
Deficit | |
Balance, January 1, 2023 | |
| 506,637 | | |
$ | 507 | | |
| 115,477 | | |
$ | 115 | | |
| 1,963,322 | | |
$ | 1,963 | | |
$ | 28,355,230 | | |
$ | (33,931,428 | ) | |
$ | (5,573,613 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,173,408 | ) | |
| (2,173,408 | ) |
Balance, March 31, 2023 | |
| 506,637 | | |
$ | 507 | | |
| 115,477 | | |
$ | 115 | | |
| 1,963,322 | | |
$ | 1,963 | | |
$ | 28,355,230 | | |
| (36,104,836 | ) | |
| (7,747,021 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,235,614 | ) | |
| (2,235,614 | ) |
Balances, June 30, 2023 | |
| 506,637 | | |
$ | 507 | | |
| 115,477 | | |
$ | 115 | | |
| 1,963,322 | | |
$ | 1,963 | | |
$ | 28,355,230 | | |
$ | (38,340,450 | ) | |
$ | (9,982,635 | ) |
|
|
For the Three and Six Months Ended June 30, 2024 |
| |
Convertible Series A Preferred Stock | | |
Convertible Series Seed Preferred Stock | | |
Common Stock | | |
Additional Paid | | |
Accumulated | | |
Stockholder’s | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
In Capital | | |
Deficit | | |
Deficit | |
Balance, January 1, 2024 | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| 6,508,897 | | |
$ | 6,509 | | |
$ | 47,148,361 | | |
$ | (48,558,111 | ) | |
$ | (1,403,241 | ) |
Warrants exercised | |
| - | | |
| - | | |
| - | | |
| - | | |
| 11,000 | | |
$ | 11 | | |
| 26,169 | | |
| - | | |
| 26,180 | |
Additional paid in capital from warrants issued under consulting agreement | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 15,543 | | |
| - | | |
| 15,543 | |
Additional paid in capital form warrants issued as debt discount | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 97,465 | | |
| - | | |
| 97,465 | |
Common stock issued from agreements | |
| - | | |
| - | | |
| - | | |
| - | | |
| 75,000 | | |
| 75 | | |
| 200,175 | | |
| - | | |
| 200,250 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,120,651 | ) | |
| (2,120,651 | ) |
Balance, March 31, 2024 | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| 6,594,897 | | |
$ | 6,595 | | |
$ | 47,487,713 | | |
| (50,678,762 | ) | |
| (3,184,454 | ) |
Balance | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| 6,594,897 | | |
$ | 6,595 | | |
$ | 47,487,713 | | |
| (50,678,762 | ) | |
| (3,184,454 | ) |
Additional paid in capital from warrants issued under consulting agreement | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 44,853 | | |
| - | | |
| 44,853 | |
Common stock issued from agreements | |
| - | | |
| - | | |
| - | | |
| - | | |
| 246,724 | | |
| 247 | | |
| 798,682 | | |
| - | | |
| 798,929 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,917,710 | ) | |
| (2,917,710 | ) |
Balances, June 30, 2024 | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| 6,841,621 | | |
$ | 6,842 | | |
$ | 48,331,248 | | |
$ | (53,596,472 | ) | |
$ | (5,258,382 | ) |
Balances | |
| - | | |
$ | - | | |
| - | | |
$ | - | | |
| 6,841,621 | | |
$ | 6,842 | | |
$ | 48,331,248 | | |
$ | (53,596,472 | ) | |
$ | (5,258,382 | ) |
The
accompanying notes are an integral part of these unaudited condensed financial statements
NeurAxis,
Inc.
Condensed
Statements of Cash Flows (Unaudited)
| |
2024 | | |
2023 | |
| |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
Cash Flows from Operating Activities | |
| | | |
| | |
Net Loss | |
$ | (5,038,361 | ) | |
$ | (4,409,022 | ) |
Adjustments to reconcile net loss to net cash used by operating activities: | |
| | | |
| | |
Amortization of debt discount and issuance cost | |
| 85,500 | | |
| 3,550,592 | |
Depreciation and amortization | |
| 21,707 | | |
| 20,060 | |
Provisions for losses on accounts receivable | |
| 20,001 | | |
| 3,927 | |
Non-cash lease expense | |
| 31,152 | | |
| 15,559 | |
Stock-based compensation | |
| 227,000 | | |
| — | |
Extinguishment of derivative liability | |
| — | | |
| (1,129,498 | ) |
Issuance of common stock for non-cash consideration | |
| 831,382 | | |
| — | |
Fair value of warrants issued for non-cash consideration | |
| 60,396 | | |
| — | |
Finance charges | |
| — | | |
| 2,772 | |
Change in fair value of derivative liabilities | |
| — | | |
| (192,157 | ) |
Change in fair value of warrant liabilities | |
| 1,708 | | |
| (198,757 | ) |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (93,964 | ) | |
| (66,698 | ) |
Inventory | |
| (21,490 | ) | |
| 3,928 | |
Prepaids and other current assets | |
| 13,342 | | |
| (20,607 | ) |
Accounts payable | |
| (85,902 | ) | |
| 846,001 | |
Accrued expenses | |
| 1,007,508 | | |
| 340,318 | |
Customer deposits | |
| 7,175 | | |
| 2,143 | |
Operating lease liability | |
| (14,449 | ) | |
| (16,698 | ) |
Net cash used by operating activities | |
| (2,947,295 | ) | |
| (1,248,137 | ) |
| |
| | | |
| | |
Cash Flows from Investing Activities | |
| | | |
| | |
Additions to property and equipment | |
| (23,408 | ) | |
| (12,067 | ) |
Additions to intangible assets | |
| — | | |
| (1,000 | ) |
Net cash used by investing activities | |
| (23,408 | ) | |
| (13,067 | ) |
| |
| | | |
| | |
Cash Flows from Financing Activities | |
| | | |
| | |
Offering costs paid | |
| — | | |
| (204,407 | ) |
Proceeds from exercised warrants | |
| 26,180 | | |
| — | |
Principal payments on notes payable | |
| (109,263 | ) | |
| (2,724,479 | ) |
Proceeds from notes payable | |
| — | | |
| 159,831 | |
Proceeds from convertible notes, net of fees | |
| 4,740,500 | | |
| 3,828,000 | |
Net cash provided by financing activities | |
| 4,657,417 | | |
| 1,058,945 | |
| |
| | | |
| | |
Net Increase (Decrease) in Cash and Cash Equivalents | |
| 1,686,714 | | |
| (202,259 | ) |
| |
| | | |
| | |
Cash and Cash Equivalents at Beginning of Period | |
| 78,560 | | |
| 253,699 | |
| |
| | | |
| | |
Cash and Cash Equivalents at End of Period | |
$ | 1,765,274 | | |
$ | 51,440 | |
| |
| | | |
| | |
Supplemental Disclosure of Non-Cash Operating Activities | |
| | | |
| | |
Cash paid for interest | |
$ | 27,670 | | |
$ | 57,202 | |
Cash paid for income taxes | |
| — | | |
| — | |
Supplemental Schedule of Non-Cash Investing and Financing Activities | |
| | | |
| | |
Recognition of right of use asset | |
$ | 284,339 | | |
$ | — | |
Fair value of warrant liabilities from convertible notes | |
| — | | |
| 1,881,257 | |
Fair value of derivative liabilities of conversion feature from convertible notes | |
| — | | |
| 1,860,984 | |
Fair value of warrants from debt discount in convertible notes classified as additional paid in capital | |
| 97,465 | | |
| — | |
The
accompanying notes are an integral part of these unaudited condensed financial statements
1.
Basis of Presentation, Organization and Other Matters
NeurAxis,
Inc. (“we,” “us,” the “Company,” or “NeurAxis”) was established in 2011 and incorporated
in the state of Indiana on April 17, 2012, under the name of Innovative Health Solutions, Inc. The name was changed to NeurAxis, Inc.
in March of 2022. Additionally, the Company filed a Certificate of Conversion to become a Delaware corporation on June 23, 2022. The
authorized shares were increased, and a par value established.
On
January 10, 2023, the Company’s board of directors authorized a 1-for-2 reverse stock split. All per share information has been
adjusted for this reverse stock split. The reverse split became effective on January 12, 2023. All share and per share amounts for the
common stock have been retroactively restated to give effect to the splits.
As
part of the conversion to a Delaware corporation, the total number of shares of all classes of stock which the Corporation shall have
authority to issue is (1) 100,000,000 shares of Common Stock, par value $0.001 per share (“Common Stock”) and (ii) 1,120,000
shares of Preferred Stock, par value $0.001 per share (“Preferred Stock”), 1,000,000 of which is hereby designated as “Series
A Preferred Stock” and 120,000 of which is hereby designated as “Series Seed Preferred Stock” with the rights, preferences,
powers, privileges and restrictions, qualifications and limitations set forth in this Article IV of the Delaware Certificate of Incorporation.
All share amounts have been retroactively restated to give effect to these changes.
On
August 9, 2023, the Company consummated an initial public offering, conducted on a firm commitment basis, pursuant to which it sold 1,098,667
shares of its common stock at a price of $6.00 per share, resulting in gross proceeds to the Company of $6,592,002. Net proceeds to the
Company, after deducting underwriting discounts and commissions, 2022 deferred offering costs totaling $736,736 and offering expenses
paid by the Company, were $4,110,721. All shares sold in our IPO were registered pursuant to a registration statement on Form S-1 (File
No. 333- 269179), as amended, declared effective by the SEC on August 9, 2023. Alexander Capital L.P. (“Alexander”) acted
as sole book-running manager for the offering and Spartan Capital Securities, LLC acted as co-manager for the offering. The underwriters
did not exercise their option to purchase up to an additional 164,801 shares of common stock. The Company paid the underwriters an underwriting
discount of seven percent (7%) of the amount raised in the offering. In addition, we also paid the underwriters a non-accountable expense
allowance in the amount of 1% (such 8% in commissions and fees amounted to a total of $527,000) at closing, as well as $175,000 for the
reimbursement of certain of the underwriters’ expenses. Additionally, as partial consideration for services rendered in connection
with the offering, the Company issued Alexander unregistered warrants to purchase an aggregate of 65,921 shares of Company common stock,
representing 6.0% of the aggregate shares sold in the offering. The warrants have an initial exercise price of $7.20 per share (equal
to 120% of the offering price per share), have a term of five years from the commencement of sales in the offering, and are exercisable
at any time.
The
Company is headquartered in Carmel, Indiana. The Company specializes in the development, production, and sale of medical neuromodulation
devices.
The
Company has developed three FDA cleared products, the IB-STIM (DEN180057, 2019), the NSS-2 Bridge (DEN170018, 2017), and the original
510(K) clearance (K140530, 2014).
|
● |
The
IB-STIM is a percutaneous electrical nerve field stimulator (PENFS) device that is indicated in patients 11-18 years of age with
functional abdominal pain associated with irritable bowel syndrome. The IB-STIM currently is the only product marketed and sold by
the Company. |
|
|
|
|
● |
The
NSS-2 Bridge is a percutaneous nerve field stimulator (PNFS) device indicated for use in the reduction of the symptoms of opioid
withdrawal. The NSS-2 Bridge device was licensed to Masimo Corporation in April 2020, and the Company received a one-time licensing
fee of $250,000 from Masimo. Masimo markets and sells this product as its Masimo Bridge, and the Company will not receive any further
licensing payments or other revenue from this product. |
|
|
|
|
● |
The
original 510(K) device was the EAD, an electroacupuncture device, now called NeuroStim. The EAD is no longer being manufactured,
sold or distributed but reserved only for research purposes. |
The
Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States
of America (“U.S. GAAP”) and following the requirements of the U.S. Securities and Exchange Commission (“SEC”)
for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by
U.S. GAAP can be condensed or omitted. These interim financial statements have been prepared on the same basis as the Company’s
annual financial statements and, in the opinion of management, reflect all adjustments which are necessary for a fair presentation of
the Company’s financial information. These unaudited interim results are not necessarily indicative of the results to be expected
for the year ending December 31, 2024, or any other interim period or for any other future year. These unaudited financial statements
should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December
31, 2023.
2.
Summary of Significant Accounting Policies
Use
of Estimates and Critical Accounting Estimates and Assumptions
The
preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S.
GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during
the reporting periods.
These
significant accounting estimates or assumptions bear the risk of change due to the fact that there are uncertainties attached to these
estimates or assumptions, and certain estimates or assumptions are difficult to measure or value.
Management
bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial
statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values
of assets and liabilities that are not readily apparent from other sources.
Management
regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes
in facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates
are adjusted accordingly. The Company uses estimates in accounting for, among other items, revenue recognition, allowance for credit
losses, stock-based compensation, income tax provisions, excess and obsolete inventory reserve, and impairment of property and equipment,
and intellectual property. Actual results could differ from those estimates.
Fair
Value Measurements
The
Company accounts for financial instruments in accordance with ASC 820, Fair Value Measurements and Disclosures (“ASC 820”).
ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques 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 measurements) and
the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820 are described
below:
Level
1 – Quoted prices (unadjusted) for identical unrestricted assets or liabilities in active markets that the reporting entity has
the ability to access as of the measurement date.
Level
2 – Significant other observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities: quoted
prices in markets that are not active; or financial instruments for which all significant inputs are observable or can be corroborated
by observable market date, either directly or indirectly.
Level
3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets
or liabilities. These unobservable inputs reflect that reporting entity’s own assumptions about assumptions that market participants
would use in pricing the asset or liability. Level 3 assets and liabilities include financial instruments whose value is determined using
pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair
value require significant management judgment or estimation.
The
Company’s Level 1 assets/liabilities include cash, accounts receivable, accounts payable, prepaids, and other current assets. Management
believes the estimated fair value of these accounts on June 30, 2024 approximate their carrying value as reflected in the balance sheets
due to the short-term nature of these instruments or the use of market interest rates for debt instruments.
The
Company’s Level 3 assets/liabilities include derivative and warrant liabilities. Inputs to determine fair value are generally unobservable
and typically reflect management’s estimates of assumptions that market participants would use in pricing the asset or liability.
The fair values are therefore determined using model-based techniques, including option pricing models and discounted cash flow models.
The valuation techniques involve management’s estimates and judgment based on unobservable inputs. The fair value estimates may
not be indicative of the amounts that would be realized in a market exchange. Additionally, there may be inherent uncertainties or changes
in the underlying assumptions used, which could significantly affect the current or future fair value estimates. Unobservable inputs
used in the models are significant to the fair values of the assets and liabilities.
There
were no transfers between any of the levels during the periods ended June 30, 2024 and December 31, 2023. In addition to assets and liabilities
that are recorded at fair value on a recurring basis, the Company’s assets and liabilities are also subject to nonrecurring fair
value measurements. As of June 30, 2024 and December 31, 2023, the Company had no assets that were measured on a nonrecurring basis.
Basic
and Diluted Net Income (Loss) per Share
Earnings
or loss per share (“EPS”) is computed by dividing net income (loss), net of preferred stock dividends, by the weighted average
number of shares of common stock outstanding during the period. Diluted EPS is computed by dividing net income (loss) by the weighted
average of all potentially dilutive shares of common stock that were outstanding during the periods presented. As of June 30, 2024 and
December 31, 2023, there were no preferred stock dividends declared or paid.
Basic
net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common
shares outstanding during the period. Diluted net loss per common share is determined using the weighted-average number of common shares
outstanding during the period, adjusted for the dilutive effect of common stock equivalents. In periods when losses are reported, which
is the case for June 30, 2024 and 2023 presented in these financial statements, the weighted-average number of common shares outstanding
excludes common stock equivalents because their inclusion would be anti-dilutive.
The
Company had the following potentially dilutive common stock equivalents at June 30, 2024 and 2023:
Schedule of Dilutive Common Stock Equivalents
| |
2024 | | |
2023 | |
| |
| | |
| |
Convertible Series A Preferred Stock | |
| — | | |
| 1,013,270 | |
Convertible Series Seed Preferred Stock | |
| — | | |
| 230,954 | |
Options | |
| 1,319,394 | | |
| 1,319,394 | |
Pre-Funded Warrants for Common Stock | |
| 289,779 | | |
| 289,779 | |
Warrants | |
| 1,880,307 | | |
| 854,795 | |
Convertible Bridge Debt | |
| — | | |
| 1,285,877 | |
Totals | |
| 3,489,480 | | |
| 4,994,069 | |
The
following table presents the calculation of the basic and diluted net loss per share and the effect of preferred stock dividends:
Schedule of Basic and Diluted Net Loss Per Share
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Numerator: | |
| | |
| | |
| | |
| |
Net loss | |
$ | (2,917,710 | ) | |
$ | (2,235,614 | ) | |
$ | (5,038,361 | ) | |
$ | (4,409,022 | ) |
Preferred stock dividends | |
| - | | |
| (190,699 | ) | |
| - | | |
| (379,303 | ) |
Net income (loss) available to common stockholders | |
| (2,917,710 | ) | |
| (2,426,313 | ) | |
| (5,038,361 | ) | |
| (4,788,325 | ) |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted average shares of common stock outstanding - basic and diluted | |
| 6,921,004 | | |
| 2,003,322 | | |
| 6,902,841 | | |
| 2,003,322 | |
Basic and diluted net loss per share | |
$ | (0.42 | ) | |
$ | (1.21 | ) | |
$ | (0.73 | ) | |
$ | (2.39 | ) |
Revenue
Recognition
Neuraxis,
Inc. specializes in the development, production, and sale of medical neuromodulation devices to healthcare providers primarily located
in the United States. Patented and trademarked neuromodulation devices is the Company’s major product line. Products are generally
transferred at a point in time (rather than over time). Essentially all the Company’s revenue is generated from purchase order
contracts.
In
accordance with FASB’s ASC 606, Revenue from Contracts with Customers, (“ASC 606”), the Company recognizes revenue
when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects
to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within
the scope of ASC 606, it performs the following five steps:
|
(i) |
identify
the contract(s) with a customer; |
|
(ii) |
identify
the performance obligations in the contract; |
|
(iii) |
determine
the transaction price; |
|
(iv) |
allocate
the transaction price to the performance obligations in the contract; and |
|
(v) |
recognize
revenue when (or as) the entity satisfies a performance obligation. |
The
Company applies the five-step model to contracts when it determines that it is probable it will collect substantially all the consideration
it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined
to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that
are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the
amount of the transaction price, after consideration of variability and constraints, if any, that is allocated to the respective performance
obligation when the performance obligation is satisfied.
The
Company estimates credit losses on accounts receivable by estimating expected credit losses over the contractual term of the receivable
using a discounted cash flow method. When developing this estimate of expected credit losses, the Company considers all available information
(past, current, and future) relevant to assessing the collectability of cash flows.
The
Company offers a Patient Assistance Program for patients without insurance coverage for IB-Stim. This program extends potential self-pay
discounts for IB-Stim devices, based upon household income and size.
Also,
the Company offers providers an opt-in program to address adequate insurance claim payments on IB-Stim devices. This program may extend
a rebate or invoice credit where the insurance payment and patient responsibility (i.e., deductible, co-payment, and/or co-insurance
amounts required by the Payer) are less than the acquisition cost of the IB-Stim device. The Company recognizes revenue at such a time
that collection of the amount due is assured.
The
following economic factors affect the nature, amount, timing, and uncertainty of the Company’s revenue and cash flows as indicated:
Type
of customer: Based on dollar amounts of revenue, essentially all of the goods sold by the Company are sold to healthcare customers
including hospitals and clinics. Sales to healthcare customers lack seasonality and have a mild correlation with economic cycles.
Geographical
location of customers: Sales to customers located within the United States represent essentially all of the Company’s sales.
Type
of contract: Sales contracts consist of purchase order contracts that tend to be short-term (i.e., less than or equal to one year
in duration).
Company’s
Performance Obligations with Customers:
Timing
of Satisfaction
The
Company typically satisfies its performance obligations as the goods are shipped.
Goods
that are shipped to customers are typically shipped FOB shipping point with freight prepaid by the Company. As such, ownership of goods
in transit transfer to the customer when shipped and the customer bears the associated risks (e.g., loss, damage, delay).
Shipping
and handling costs are recorded as general and administrative expenses in the Statement of Operations.
Significant
Payment Terms
Payment
for goods sold by the Company is typically due after an invoice is sent to the customer, within 30 days. However, other payment terms
are frequently negotiated with customers ranging from due upon receipt to due within 90 days. Some payment terms may call for payment
only after the healthcare provider receives their insurance reimbursement. Invoices for goods are typically sent to customers within
three calendar days of shipment. The Company does not offer discounts if the customer pays some or all of an invoiced amount prior to
the due date.
None
of the Company’s contracts have a significant financing component.
Nature
Medical
devices that the Company contracts to sell and transfer to customers are manufactured by one specific third-party manufacturer. The manufacturer
is located within the state of Indiana. In no case does the Company act as an agent (i.e., the Company does not provide a service of
arranging for another party to transfer goods to the customer).
Returns,
Refunds, etc.
Orders
may not be cancelled after shipment. Customers may return devices within 10 days of delivery if the goods are found to be defective,
nonconforming, or otherwise do not meet the stated technical specifications. At the option of the customer, the Company shall either:
|
● |
Refund
the price paid for any defective or nonconforming products. |
|
● |
Supply
and deliver to the customer replacement conforming products. |
|
● |
Reimburse
the customer for the cost of repairing any defective or nonconforming products. |
At
the time revenue is recognized, the Company estimates expected returns and excludes those amounts from revenue. The Company also maintains
appropriate accounts to reflect the effects of expected returns on the Company’s financial position and periodically adjusts those
accounts to reflect its actual return experience. Historically, returns have been immaterial, and the Company currently does not provide
a provision for this liability.
Going
Concern
We
have incurred losses since inception and have funded our operations primarily with a combination of sales, debt, and the sale of capital
stock. As of June 30, 2024, we had a stockholders’ deficit of $5,258,382
and short-term outstanding borrowings of $4,767,335.
As June 30, 2024, we had cash of $1,765,274
and a working capital deficit of $5,482,316.
On
August 9, 2023, the Company consummated its initial public offering, conducted on a firm commitment basis, pursuant to which it sold
1,098,667 shares of its common stock at a price of $6.00 per share, resulting in gross proceeds to the Company of $6,592,002. Net proceeds
to the Company, after deducting underwriting discounts and commissions, 2022 deferred offering costs totaling $736,736 and offering expenses
paid by the Company, were $4,110,721. All shares sold in our IPO were registered pursuant to a registration statement on Form S-1 (File
No. 333- 269179), as amended, declared effective by the SEC on August 9, 2023. Alexander Capital L.P. acted as sole book-running manager
for the offering and Spartan Capital Securities, LLC acted as co-manager for the offering. The underwriters did not exercise their option
to purchase up to an additional 164,801 shares of common stock.
Our
future capital requirements will depend upon many factors, including progress with developing, manufacturing, and marketing our technologies,
the time and costs involved in preparing, filing, prosecuting, maintaining, and enforcing patent claims and other proprietary rights,
our ability to establish collaborative arrangements, marketing activities and competing technological and market developments, including
regulatory changes and overall economic conditions in our target markets. Our ability to generate revenue and achieve profitability requires
us to successfully market and secure purchase orders for our products from customers currently identified in our sales pipeline and to
new customers as well. The primary activity that will drive all customers and revenues is the adoption of insurance coverage by commercial
insurance carriers nationally, which is a top priority of the Company. These activities, including our planned research and development
efforts, will require significant uses of working capital through the rest of 2024 and beyond. Based on our current operating plans,
we believe that our existing cash at the time of this filing will only be sufficient to meet our anticipated operating needs through
the end of 2024.
Management
evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going
concern for a period of one year from the date the financial statements are issued.
To
date, the Company has experienced operating losses and negative cash flows from operations. Management believes that increased sales
and acceptance of their product by insurance providers will allow the Company to achieve profitability in the near term.
While
the Company believes in the viability of its strategy to further implement its business plan and generate sufficient revenues and in
its ability to raise additional funds by way of a public or private offering of its debt or equity securities, there can be no assurance
that it will be able to do so on reasonable terms, or at all. The ability of the Company to continue as a going concern is dependent
upon its ability to further implement its business plan and generate sufficient revenues and its ability to raise additional funds by
way of a public or private offering. Neither future cash generated from operating activities, nor management’s contingency plans
to mitigate the risk and extend cash resources through the evaluation period, are considered probable. As a result, substantial doubt
is deemed to exist about the Company’s ability to continue as a going concern. As we continue to incur losses, our transition to
profitability is dependent upon achieving a level of revenues adequate to support its cost structure. We may never achieve profitability,
and unless and until doing so, we intend to fund future operations through additional dilutive or nondilutive financing. There can be
no assurances, however, that additional funding will be available on terms acceptable to us, if at all.
The
financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the
amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
Recently
Issued Accounting Pronouncements
In
December 2023, the FASB issued ASU 2023-19, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires the enhancement
of income tax disclosures to provide better insight into how an entity’s operations and related tax risks, planning and opportunities
affect its tax rate and prospects for future cash flows. The enhanced disclosures require (i) specific categories in a tabular rate reconciliation
including both amounts and percentages and (ii) additional information for reconciling items and income tax paid that meet a quantitative
threshold. Public business entities are required to adopt the standard for annual periods beginning after December 15, 2024. All other
entities are required to adopt the standard for annual periods beginning after December 15, 2025. The adoption of the standard is not
expected to have a material impact on the Company’s financial statements.
3.
Related Party Transactions
The
Company has two demand notes receivable from shareholders related to the sale of common stock on January 1, 2016. Both notes’ initial
balances were $506,400, with interest calculated monthly based on applicable federal rates. No payments have been received on the notes.
Since repayment is not assured, the Company provided an allowance for the entire balance of principal and interest as of December 31,
2019. The current allowance is $1,012,800 as of June 30, 2024. The current loan balances are as follows:
Schedule of Related Party Transactions
| |
Loan | | |
Interest | | |
Interest | |
| |
Receivable | | |
Receivable | | |
Income | |
June 30, 2024 | |
| | | |
| | | |
| | |
Shareholder 1 | |
$ | 506,400 | | |
$ | 83,042 | | |
$ | 12,104 | |
Shareholder 2 | |
| 506,400 | | |
| 82,907 | | |
| 12,104 | |
| |
| 1,012,800 | | |
| 165,949 | | |
| 24,208 | |
Allowance for Collection Risk | |
| (1,012,800 | ) | |
| (165,949 | ) | |
| (24,208 | ) |
Net Balance | |
$ | — | | |
$ | — | | |
$ | — | |
| |
Loan | | |
Interest | | |
Interest | |
| |
Receivable | | |
Receivable | | |
Income | |
December 31, 2023 | |
| | | |
| | | |
| | |
Shareholder 1 | |
$ | 506,400 | | |
$ | 70,938 | | |
$ | 23,867 | |
Shareholder 2 | |
| 506,400 | | |
| 70,803 | | |
| 23,867 | |
| |
| 1,012,800 | | |
| 141,741 | | |
| 47,734 | |
Allowance for Collection Risk | |
| (1,012,800 | ) | |
| (141,741 | ) | |
| (47,734 | ) |
Net Balance | |
$ | — | | |
$ | — | | |
$ | — | |
Mr.
Bradley Mitch Watkins, Director, provided certain sales, marketing and commercialization consulting services to the Company prior to
his appointment to the Board of Directors. For the six months ended June 30, 2024 and 2023, the Company paid Mr. Watkins $0 and $4,708,
respectively, for these services. No amounts were owed to Mr. Watkins as June 30, 2024 and December 31, 2023, respectively, for these
services.
The
Company’s former Chief Financial Officer is contracted for services through a third-party public accounting firm. He is the firm’s
managing partner and majority shareholder. The firm is engaged by the Company to provide accounting and tax services on a continuous
basis. Fees paid for services were $127,550
and $64,932
for the six months ended June 30, 2024 and 2023,
respectively. The Company owed RBSK for open invoices of $47,897
and $84,279
that are included in accounts payable as of June
30, 2024 and December 31, 2023, respectively.
4.
Notes Payable
The
Company borrowed $250,000 on December 16, 2021, from Channel Partners Capital. The note called for 65 weekly payments of $4,923 with
the final payment scheduled for March 16, 2023. The note’s interest rate computes to a nominal rate of 40.9%. The principal outstanding
as of January 1, 2022 was $244,048. The Company borrowed $122,000 on September 16, 2022, to bring the principal balance back to $250,000.
After making scheduled payments, the Company borrowed $107,231 on May 24, 2023, to bring the principal balance back to $250,000. The
terms of the note are the same as the previous note with the final payment scheduled for August 22, 2024. The principal outstanding as
of June 30, 2024 and December 31, 2023 was $38,797 and $148,062, respectively. The Company believes that the advancement of additional
funds is a minor modification to the terms of the existing loan since the difference in present value of the cash flows under the terms
of the new loan is less than 10% of the present value of the remaining cash flows under the terms of the original loan. As a result,
the modification was accounted for as a modification of debt.
The
lender was granted and assigned a continuing security interest in all the Company’s personal property assets including, but not
limited to, business equipment, inventory, accounts, accounts receivable, intellectual property, chattel paper, instruments, deposit
accounts, commercial tort claims, contract rights, licenses, claims, and general intangibles.
Interest
expense totaled $7,840 and $21,735 for the three and six months ended June 30, 2024. The future minimum principal payments to be
paid in 2024 is $38,797.
On
November 8, 2023, the Company entered into a Securities Purchase Agreement (“SPA”) with a shareholder for the issuance 1,260,504
shares of Series B Convertible Preferred Stock, par value $0.001 per share (the “Series B Preferred Stock”), for an aggregate
purchase price of $3,000,000 paid in 15 monthly installments of $200,000 each, commencing on the later of January 10, 2024 or a date
after stockholders approve an amendment to the Company’s Certificate of Incorporation to authorize the creation of the Series B
Preferred Stock (the “Stockholder Approval”). The Series B Preferred Stock is convertible at any time into shares of common
stock of the Company without any further consideration. Following the issuance of the Series B Preferred Stock, it will rank senior to
the common stock with respect to payments upon the liquidation, dissolution and winding up of the Company. Due to a delay in Stockholder
Approval, the Company amended the SPA on February 12, 2024 to issue a promissory note, due and payable on the earlier of 15 months or
12 months if the Series B Preferred Stock has not been authorized, convertible into Series B Preferred Stock with identical funding amounts
and terms.
In
February and March of 2024, the Company entered into a series of convertible promissory notes totaling $3,135,000 with terms identical
to the $3,000,000 convertible promissory note issued on February 12, 2024 (collectively referred to as the “Original 2024 Convertible
Promissory Notes”).
The
2024 Original Convertible Promissory Notes bear interest at 8.5% per annum payable quarterly in either cash or common stock at the election
of the Company. At any time following the date of shareholder approval to authorize the creation of Series B Preferred Stock prior to
the maturity date, the investor may elect to convert all or part of the principal into the Company’s Series B Preferred Stock at
a conversion price per share equal to $2.38. Without limiting the forgoing, all principal amounts outstanding on the maturity date will
automatically convert into the Company’s Series B Preferred Stock. The Series B Preferred Stock is entitled to cumulative dividends
at 8.5% per annum (whether or not declared) payable quarterly in either cash or common stock at the $2.38 conversion price at the election
of the Company. Upon conversion to Series B Preferred Stock, the investor may elect, at its option at any time, to convert all or part
of the Series B Preferred Stock plus accrued but unpaid dividends into an equivalent amount of common stock at the $2.38 conversion price.
As of June 30, 2024, no investor has converted any portion of the Original 2024 Convertible Notes into Series B Preferred Stock as the
shareholders have not yet authorized its issuance.
On
May 21, 2024, the Company entered into three convertible promissory notes with related institutional accredited investors with terms
similar to the Original 2024 Convertible Promissory Notes (collectively referred to as the “Amended 2024 Convertible Promissory
Notes”) for an additional amount of $3,000,000. Certain provisions to the SPA and Certificate of Designation previously issued
on February 12, 2024 changed, including (i) the number of shares of preferred stock to be designated as Series B Preferred Stock was
increased from 1,500,000 to 5,000,000, (ii) the stated value of the Series B Preferred Stock was changed from $1.00 to $2.38 per share,
(iii) the right to receive dividends will expire automatically on June 30, 2025, (iv) the liquidation rights will automatically expire
on June 30, 2025, and (v) the number of shares of the common stock that a holder of Series B preferred stock is entitled to receive
shall not exceed the maximum percentage chosen by the holder, which is initially set at between 4.99% and 19.99% until shareholder approval
is obtained, of the number of outstanding shares of the common stock at the time of the conversion of the Series B preferred stock shares.
The
maturity date shall be on the earlier of (i) June 21, 2025, (ii) upon written demand occurring on or after March 21, 2025 in the event
that the Series B preferred shares have not been duly authorized on or before such date, or (iii) immediately upon the occurrence of
an event of default. Automatic conversion into shares of Series B preferred stock (at a conversion price of $2.38 per share) will occur
following the date of shareholder approval. In the event the Company fails to obtain shareholder approval before August 15, 2024, rights
exist to convert the outstanding amount into shares of the common stock, at a price per share of $2.38.
As
of June 30, 2024, the Company received $4,935,000 of the principal amount of the Amended 2024 Convertible Notes with the remainder due
in monthly installments through March of 2025.
The
Company’s private placement agent fees included (i) 10% of the Original 2024 Convertible Promissory Notes funded principal amount
and (ii) warrants calculated as 6.0% of the funded principal amount divided by the $2.38 exercise price. The fair value of the warrants
of $97,465 were deferred as a financing fee and classified as additional paid in capital. The private placement agreement was terminated
on March 18, 2024 pursuant to an new advisory agreement (See Note 12).
Accrued
interest totaled $66,648 as
of June 30, 2024 and December 31, 2023, respectively. On June 28, 2024, the Company paid $79,588 in
accrued interest for the first and second quarters of 2024 on the Amended 2024 Convertible Promissory Notes in the form of 33,454 shares
of the Company’s common stock . The unamortized debt discount on the Amended 2024 Convertible Promissory Notes total $206,464 as
of June 30, 2024. Interest expense totaled $72,857 and $85,522 for the three and six months ended June 30, 2024, respectively.
Amortization of the debt discount on the Amended 2024 Convertible Notes totaled $63,817 and $85,500 for
the three and six months ended June 30, 2024, respectively.
5.
Leases
At
the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and
circumstances present in the arrangement. Leases with a term greater than one year are recognized on the balance sheet as right-of-use
assets and current and non-current lease liabilities, as applicable.
Operating
lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over
the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received.
The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental
borrowing rate to discount lease payments, which reflects the fixed rate at which the Company could borrow on a collateralized basis
the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. Prospectively, the Company
will adjust the right-of-use assets for straight-line rent expense, or any incentives received and remeasure the lease liability at the
net present value using the same incremental borrowing rate that was in effect as of the lease commencement or transition date. The Company
has elected not to recognize leases with an original term of one year or less on the balance sheet. The Company typically only includes
an initial lease term in its assessment of a lease arrangement. Options to renew a lease are not included in the Company’s assessment
unless there is reasonable certainty that the Company will renew.
Assumptions
made by the Company at the commencement date are re-evaluated upon occurrence of certain events, including a lease modification. A lease
modification results in a separate contract when the modification grants the lessee an additional right of use not included in the original
lease and when lease payments increase commensurate with the standalone price for the additional right of use. When a lease modification
results in a separate contract, it is accounted for in the same manner as a new lease.
Entities
may elect not to separate lease and non-lease components. The Company has elected to account for lease and non-lease components together
as a single lease component for all underlying assets and allocate all the contract consideration to the lease component only.
The
Company’s leases are comprised of operating leases for office space. At the inception of the lease, the Company determines whether
the lease contract conveys the right to control the use of identified property for a period of time in exchange for consideration. Leases
are classified as operating or finance leases at the commencement date of the lease. Operating leases are recorded as operating lease
right-of-use assets, other current liabilities, and operating lease liabilities in the Balance Sheets. The Company did not have any finance
leases as of June 30, 2024 and December 31, 2023.
The
Company had three leases primarily consisting of office space in Versailles and Carmel, Indiana. Two
of the leases in Versailles started January 1, 2022. Both have an term of one year, with automatic one year renewal, unless 60 day notice
of vacating is given, commencing on the execution hereof and continuing through December 31st of each year. The monthly lease
payments for these leases are $470 and $1,664 with a 4% per annum increase. The new lease in Carmel started January 1, 2024. The initial
term is five years and five months. The monthly lease payment started at $6,721 with an annual increase of 2.5%. As long as the Company
is not in default, it is only obligated to pay an amount equal to 50% of the monthly base rent for months 1-10.
Operating
lease right-of-use assets and liabilities are recognized at the commencement date based on the present value of lease payments over the
lease term. As the implicit interest rate is generally not readily determinable, the Company uses an incremental borrowing rate based
on the information available at the commencement date in determining the present value of lease payments. The incremental borrowing rate
reflects the estimated rate of interest that the Company would pay to borrow on a collateralized basis over a similar economic environment.
Lease expense for the operating lease is recognized on a straight-line basis over the lease term.
Leases
may include renewal options, and the renewal option is included in the lease term if the Company concludes that it is reasonably certain
that the option will be exercised. Certain leases may contain rent escalation clauses, either fixed or adjusted periodically for inflation
of market rates, that are factored into the calculation of lease payments to the extent they are fixed and determinable at lease inception.
The Company also has variable lease payments that do not depend on a rate or index, primarily for items such as common area maintenance
and real estate taxes, which are recorded as expenses when incurred.
For
the six months ended June 30, 2024 and 2023, the Company recognized $46,423
and $23,704
of operating lease expense, including short-term
lease expense and variable lease costs.
The
following table presents information related to the Company’s operating leases:
Schedule of Operating Leases
| |
June 30, 2024 | | |
December 31, 2023 | |
Operating lease right-of-use assets | |
$ | 323,450 | | |
$ | 70,263 | |
| |
| | | |
| | |
Other current liabilities | |
| 48,247 | | |
| 49,127 | |
Operating lease liabilities | |
| 297,843 | | |
| 27,071 | |
Total | |
$ | 346,090 | | |
$ | 76,198 | |
| |
| | | |
| | |
Weighted-average remaining lease term (in years) | |
| 4.49 | | |
| 3.75 | |
Weighted-average discount rate | |
| 15.0 | % | |
| 15.0 | % |
As
of June 30, 2024, the maturities of the Company’s operating lease liabilities were as follows:
Schedule of Maturities Operating Lease Liabilities
| |
| | |
2024 | |
$ | 40,732 | |
2025 | |
| 111,472 | |
2026 | |
| 114,702 | |
2027 | |
| 86,856 | |
2028 | |
| 89,027 | |
Thereafter | |
| 38,025 | |
Total lease payments | |
| 480,814 | |
Less: imputed interest | |
| (134,724 | ) |
Total present value of lease payments | |
$ | 346,090 | |
6.
Common Stock and Warrants
The
Company authorized 100,000,000 shares of common stock, of which 6,841,621 and 6,508,897 shares were issued and outstanding as of June
30, 2024 and December 31, 2023, respectively. In conjunction with 1,098,667 common shares issued upon the completion of the initial public
offering on August 8, 2023, the Company also issued (i) 1,244,228 common shares upon conversion of 506,637 shares of Convertible Series
A Preferred Stock and 115,477 shares of Convertible Series Seed Preferred Stock, (ii) 1,649,900 common shares upon conversion of convertible
notes, (iii) 425,000 common shares as payment to vendors for services and (iv) 127,780 common shares upon the exercise of warrants. On
January 10, 2023, the Company’s board of directors authorized a 2-for-1 reverse stock split. All share information in these financial
statements has been adjusted for this reverse stock split.
On
January 10, 2023, the Company’s board of directors authorized a 2-for-1 reverse stock split. All share information in these financial
statements has been adjusted for this reverse stock split.
On
August 9, 2023, the Company consummated an initial public offering, conducted on a firm commitment basis, pursuant to which it sold 1,098,667
shares of its common stock at a price of $6.00 per share, resulting in gross proceeds of $6,592,002. See Note 1.
On
January 2, 2024, the Company issued 75,000 shares of common stock with a fair value of $200,250 pursuant to a consulting agreement related
to the Company’s transition to a public company. As the term of the consulting agreement covers the full fiscal year ending December
31, 2024, the Company expensed $50,062 and $100,125 in the three month and six months ended June 30, 2024, respectively, with the remaining
$100,125 recorded in prepaids and other current assets in the condensed balance sheets as of June 30, 2024.
On
January 19, 2024, the Company received proceeds of $26,180 from an existing shareholder and issued 11,000 shares of common stock upon
the exercise of a warrant agreement at $2.38 per share.
On
April 11, 2024, the Company issued 53,063 shares of common stock to an existing shareholder to settle a convertible note dispute. The
Company recorded the fair value of the settlement totaling $230,823 as financing charge in the condensed statements of operations.
On
June 28, 2024 the Company issued 90,032
shares of common stock to pre-IPO Series A Preferred
Shareholders to settle certain claims. The Company recorded the fair value of the settlement totaling $286,458
as other expense in the condensed statements
of operations.
On
June 28, 2024, the Company issued 33,454 shares of common stock to holders of the Amended 2024 Convertible Promissory Notes in lieu of
$79,588 in cash payments for interest through June 30, 2024.
On
June 28, 2024, the Company issued 24,343 shares
of common stock to its Board of Directors for their service from the Company’s IPO on August 9, 2023 through March 31, 2024.
The fair value of the services were recorded as general and administrative expense in the condensed statements of operations
totaling $39,452 from August 9, 2023 through December 31, 2023 and $28,219 during the six months ended June 30, 2024.
On
June 28, 2024, the Company issued 25,832 shares of common stock to its previous Chief Operating Officer in accordance with a severance
agreement executed on April 10, 2024. The Company recorded the fair value of the severance provision totaling $78,788 as general and
administrative expense in the condensed statements of operations.
On
June 28, 2024, the Company issued 20,000 shares of common stock to it previous CFO for services provided during the IPO. The Company
recorded the fair value of the services totaling $55,600 as general and administrative expense in the condense statements of operations.
In
connection with a bridge loan, the Company issued a warrant on September 18, 2018 that allows the holder to purchase common stock from
the Company at a share price of $4.38 per share. The number of shares was based on a formula tied to the final amount of loans made by
the holder of $375,000, multiplied by 150%, and divided by $70.03. The number of shares based on this formula is 12,852. The warrant
contains certain rights in the event of liquidation, merger, or consolidation of the Company. If the fair market value of one share is
greater than the warrant price, the holder may elect to receive a number of shares equal to the value of the warrant. If the exercise
is in connection with the sale of the Company, the holder may, at its option, condition its exercise of the warrant upon the consummation
of such transaction. The warrant expires on September 18, 2028 and can be exercisable either in whole or from time to time in part prior
to the expiration date.
The
Company issued a second warrant on September 6, 2019, under similar terms but is a penny warrant that allows the holder to purchase 40,000
shares of common stock and is subject to adjustment for certain equity events. The warrant contains certain rights in the event of liquidation,
merger, or consolidation of the Company. The warrant expires on September 6, 2029. This warrant was converted to 39,924 shares of common
stock on December 28, 2023. The fair market value of the stock on that day was calculated as the average of the daily closing prices
per share for the 30 consecutive trading day period ending on the second trading day prior to such date or $2.61 per share. Since the
fair value was greater than the warrant price of $0.01 per share the holder elected to receive the number of shares equal to 40,000 times
the difference between the fair market value and the exercise price divided by the fair market value, resulting in 39,924.
The
Company issued a third warrant to Masimo Corporation on April 9, 2020. This warrant was pre-funded in the amount of $2,734,340. The warrant
allows the holder to purchase 289,779 shares of Series A Preferred Stock at $9.44 per share and is subject to adjustment for certain
equity events. The warrant contains certain rights in the event of liquidation, merger, or consolidation of the Company. There will be
no additional purchase price for the Warrants. In the event that all outstanding shares of Series A Preferred Stock are converted, automatically
or by action of the holders thereof, into Common Stock, including, without limitation, in connection with the Company’s initial,
underwritten public offering and sale of its Common Stock pursuant to an effective registration statement under the Act, then from and
after the date on which all outstanding shares of Series A Preferred Stock have been so converted, this Warrant shall be exercisable
for such number of shares of Common Stock into which the Warrant Shares would have been converted had the Warrant Shares been outstanding
on the date of such conversion, and the Exercise Price shall equal the Exercise Price in effect as of immediately prior to such conversion
divided by the number of shares of Common Stock into which one share of Series A Preferred Stock would have been converted, all subject
to further adjustment thereafter from time to time in accordance with the provisions of this Warrant. On August 14, 2023, the 144,890
Series A Preferred Stock warrants were converted to 289,779 common stock warrants.
During
2022, the Company issued 793,655 five-year warrants to purchase common stock equal to one hundred percent (100%) of the shares into which
the 2022 convertible notes can be converted at issuance. The 2024 Convertible Promissory Notes triggered the anti-dilution clause of
the original agreement and decreased the exercise price to $2.38.
From
March to June of 2023, the Company issued 505,570 one-year warrants to purchase common stock equal to fifty percent (50%) of the shares
into which the 2023 convertible notes can be converted at issuance. The warrants have an exercise price of $5.25 per share. The 2024
Convertible Promissory Notes triggered the anti-dilution clause of the original agreement and decreased the exercise price to $2.38.
On
August 9, 2023, the Company issued 122,202 five-year warrants to purchase common stock pursuant to an advisory agreement with a consulting
firm upon closing of the Company’s initial public offering. The warrants have an exercise price of $6.00 per share. The 2024 Convertible
Promissory Notes triggered the anti-dilution clause of the original agreement and decreased the exercise price to $2.38.
On
August 14, 2023, the Company issued 186,156 five-year warrants to purchase common stock pursuant to an agreement with an underwriter
upon closing of the Company’s initial public offering. The warrants have an exercise price of $7.20 per share. The 2024 Convertible
Promissory Notes triggered the anti-dilution clause of the original agreement and decreased the exercise price to $2.38.
From
January to March of 2024, the Company issued 38,697 warrants to its private placement agent in conjunction with the 2024 Convertible
Promissory Notes at an exercise price of $2.38 to purchase common stock. The Company recorded the fair value of the services totaling
$74,278 as financing fees in the condensed balance sheets as of June 30, 2024.
From
March to June of 2024, the Company issued 30,252 warrants pursuant to a capital markets advisory agreement at an exercise price of $2.38
to purchase common stock (See Note 12). The Company recorded the fair value of the advisory services totaling $59,370 as general and
administrative expense in the condensed statements of operations.
The
following is a summary of warrant activity for common stock during the periods ended June 30, 2024 and December 31, 2023:
Schedule of Warrant Activity for Common Stock
| |
Number of | | |
Weighted-Avg. | | |
Weighted-Avg. | |
| |
Warrants for | | |
Exercise | | |
Remaining | |
| |
Common Stock | | |
Price | | |
Contractual Life | |
Outstanding as of January 1, 2023 | |
| 846,507 | | |
$ | 5.06 | | |
| 4.72 | |
Granted | |
| 813,928 | | |
| 5.81 | | |
| 4.38 | |
Converted Prefunded Warrants | |
| 289,779 | | |
| 0.01 | | |
| — | |
Exercised | |
| (127,856 | ) | |
| 2.38 | | |
| — | |
Outstanding as of December 31, 2023 | |
| 1,822,358 | | |
$ | 4.69 | | |
| 3.05 | |
Granted | |
| 68,949 | | |
$ | 2.38 | | |
| 4.73 | |
Exercised | |
| (11,000 | ) | |
| 2.38 | | |
| — | |
Outstanding as of June 30, 2024 | |
| 1,880,307 | | |
$ | 2.06 | | |
| 2.98 | |
The
following is a summary of warrant activity for preferred stock during the year ended December 31, 2023:
Schedule of Warrant Activity for Preferred Stock
| |
Number of | | |
Weighted-Avg. | |
| |
Warrants for | | |
Exercise | |
| |
Preferred Stock | | |
Price | |
Outstanding as of January 1, 2023 | |
| 144,890 | | |
$ | 0.01 | |
Granted | |
| — | | |
| — | |
Cancelled/Expired | |
| — | | |
| — | |
Exercised | |
| (144,890 | ) | |
| (0.01 | ) |
Outstanding as of December 31, 2023 | |
| — | | |
$ | — | |
There
was no preferred stock warrant activity for the three and six months ended June 30, 2024.
The
following table summarizes the Company’s warrants outstanding and exercisable as of June 30, 2024:
Schedule of Warrants outstanding and Exercisable
| |
Number of | | |
| | |
| |
| |
Warrants | | |
Exercise | | |
Expiration | |
| |
Outstanding | | |
Price | | |
Date | |
Brian Hannasch W-01 | |
| 12,852 | | |
$ | 8.76 | | |
| September 18, 2028 | |
Masimo Corporation PSA-01 | |
| 289,779 | | |
$ | 0.01 | | |
| None | |
2022 Convertible Notes | |
| 793,655 | | |
$ | 2.38 | | |
| Various | |
2023 Convertible Notes | |
| 537,949 | | |
$ | 2.38 | | |
| Various | |
Consulting Agreement Warrants | |
| 180,151 | | |
$ | 2.38 | | |
| Various | |
Underwriter’s Warrants | |
| 65,921 | | |
$ | 2.38 | | |
| August 8, 2028 | |
| |
| 1,880,307 | | |
| | | |
| | |
The
Company is a party to two investment banking and advisory agreements with a consulting firm engaged in connection with listing our common
stock for trading on NYSE. Pursuant to the first advisory agreement, dated March 3, 2022, the Company agreed to pay the consulting firm
a monthly consulting fee of $5,000 and a final payment of $50,000 upon a successful NYSE listing, and, also upon such listing, to issue
the consulting firm shares of our common stock representing 1.5% of our outstanding shares after giving effect to the initial public
offering and to issue the consulting firm five-year warrants to purchase shares of our common stock representing 2.0% of our outstanding
shares, after giving effect to the initial public offering, on a fully-diluted basis with an exercise price per share representing the
public offering price per share. Pursuant to the second advisory agreement with consulting firm, dated June 20, 2022, and amended December
20, 2022, the Company agreed to pay fees in the aggregate of up to $136,166 for advice in connection with communication and other related
matters leading up to, and in connection with, the initial public offering and to issue the consulting firm 125,000 shares of common
stock upon a successful NYSE listing. The Company agreed to piggyback registration rights with respect to all shares issued to the consulting
firm under both advisory agreements, including shares issuable upon exercise of the warrants. The Company evaluated the agreements and
determined that the shares will not be recorded and valued until the performance condition is satisfied.
7.
Preferred Stock
The
Company has authorized 1,120,000 shares of preferred stock of which 1,000,000 has been designated Series A Preferred Stock and 120,000
has been designated Series Seed Preferred Stock, of which 0 shares of Series A Preferred Stock and 0 shares of Series Seed Preferred
Stock are issued and outstanding as of June 30, 2024 and December 31, 2023, respectively.
The
following is a summary of Preferred Stock terms:
Voting
Rights - The Series A Preferred and Series Seed Preferred shall vote together with the Common Stock on an as-converted basis, and
not as separate classes.
Conversion
- The Series A Preferred and Series Seed initially convert 1:1 to Common Stock at any time at option of holder, subject to adjustments
for stock dividends, splits, combinations, and similar events and as described below under “Anti-dilution Provisions.”
Dividends
- The Series A Preferred will carry an annual 8% cumulative dividend, payable upon any liquidation, dissolution or winding up of
the Company (the “Accruing Dividend”). For any other dividends or distributions, participation with Common Stock on an as-converted
basis.
Liquidation
- In the event of any liquidation, dissolution or winding up of the Company, the proceeds shall be paid in the following priority:
First,
to the Series A Preferred in proportion to each holder’s respective pro rata Series A Original Purchase Price, plus any pro rata
share of the Accruing Dividend until the entire Series A Original Purchase Price and Accruing Dividend are paid;
Second,
to the Series Seed Preferred in proportion to each holder’s respective pro rata Series Seed Original Purchase Price until the entire
amount of the Series Seed Original Purchase Price is paid; and
Thereafter,
the Series A Preferred and Series Seed Preferred participate with the Common Stock pro rata on an as-converted basis.
A
merger or consolidation (other than one in which stockholders of the Company own a majority by voting power of the outstanding shares
of the surviving or acquiring corporation) and a sale, lease, transfer, exclusive license or other disposition of all or substantially
all of the assets of the Company will be treated as a liquidation event (a “Deemed Liquidation Event”), thereby triggering
payment of the liquidation preferences described.
Anti-dilution
Provisions - The Series A Preferred have full-ratchet anti-dilution protection so that the conversion price will be reduced to 80%
of the price at which any future shares are issued, if less than the Series A Original Purchase Price.
Preferred
stock has all converted pursuant to the initial public offering.
8.
Stock Options and Awards
The
following is a summary of stock option activity for the periods ended June 30, 2024 and December 31, 2023:
Schedule of Stock Option Activity
| |
| | |
Weighted | | |
| | |
| |
| |
| | |
Avg. | | |
| | |
| |
| |
Number of | | |
Remaining Contractual Life | | |
Weighted Avg. Exercise | | |
Aggregate Intrinsic | |
| |
Options | | |
(in years) | | |
Price | | |
Value | |
Outstanding as of January 1, 2023 | |
| 1,319,394 | | |
| 6.69 | | |
$ | 6.94 | | |
$ | — | |
Granted | |
| — | | |
| — | | |
| — | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Cancelled/Expired | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Outstanding as of December 31, 2023 | |
| 1,319,394 | | |
| 5.69 | | |
$ | 6.94 | | |
$ | — | |
Granted | |
| — | | |
| — | | |
| — | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Cancelled/Expired | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Outstanding as of June 30, 2024 | |
| 1,319,394 | | |
| 5.20 | | |
$ | 6.94 | | |
$ | — | |
Vested and Exercisable as of June 30, 2024 | |
| 1,319,394 | | |
| 5.20 | | |
$ | 6.94 | | |
$ | — | |
Stock-based
compensation expense is classified in the Company’s statements of operations as general and administrative expense. Compensation
expense totaled $227,000 and $0 for the six months ended June 30, 2024 and 2023, respectively (See Note 9). As of June 30, 2024,
there was no unrecognized compensation expense related to unvested options granted under the Company’s share-based compensation
plans.
9.
Share Liability
As
of June 30, 2024, the Company had not issued (i) 100,000
shares of its common stock pursuant to a hiring
grant of an executive officer, representing stock compensation expense of $227,000
in the six months ended June 30, 2024 and (ii)
10,145
shares of its common stock pursuant to an agreement
for marketing services representing $30,131
in advertising expense for the three and six months ended June
30, 2024, due to administrative delays. These shares are classified as share liabilities as they have been authorized but not yet issued
as of the reporting date.
The
Company expects to issue these shares to the respective shareholder as soon as the administrative delays are resolved. These shares will
be recorded as issued and outstanding upon their issuance, and the corresponding share liability will be reclassified to shareholders’
equity. The administrative delays are not expected to have any material impact on the financial position or results of operations of
the Company.
Management’s
best estimate is that the administrative delays will be resolved within the next fiscal quarter, at which point the share liabilities
will be eliminated, and the shares will be issued. However, the timing of resolution is subject to various factors, and actual timing
may vary.
10.
Warrant Liabilities
Management
evaluates all of the Company’s financial instruments and contracts, including issued warrants to purchase its Class A common stock
and Series B Preferred Stock, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives,
pursuant to ASC 480 and ASC 815-15. The classification of derivative instruments, including whether such instruments should be recorded
as liabilities or as equity, is reassessed at the end of each reporting period.
The
Company utilizes a Monte Carlo simulation model for warrants that have an option to convert at a variable number of shares to compute
the fair value of the derivative and to mark to market the fair value of the derivative at each balance sheet date. The inputs utilized
in the application of the Monte Carlo model included a starting stock price, an expected remaining term of each warrant as of the valuation
date, estimated volatility, drift, and a risk-free rate. The Company records the change in the fair value of the derivative as other
income or expense in the statements of operations.
The
Company utilizes a Monte Carlo simulation model for warrants that have an option to convert at a variable number of shares to compute
the fair value of the derivative and to mark to market the fair value of the derivative at each balance sheet date. The inputs utilized
in the application of the Monte Carlo model included a starting stock price of $9.20 per share, an expected remaining term of each warrant
as of the valuation date, estimated volatility ranging from 68% to 80%, drift, and a risk-free rate ranging from 4.00% to 4.22%.
Risk-free
interest rate: The Company uses the risk-free interest rate of a U.S. Treasury Note adjusted to be on a continuous return basis to align
with the Black-Scholes option-pricing model.
Dividend
yield: The Company uses a 0% expected dividend yield as the Company has not paid dividends to date and does not anticipate declaring
dividends in the near future.
Volatility:
The Company calculates the expected volatility based on comparable company’s historical stock prices with a look back period commensurate
with the period to maturity.
Expected
term: The Company’s remaining term is based on the remaining contractual maturity of the warrants.
The
following are the changes in the warrant liabilities during the periods ended June 30, 2024 and December 31, 2023.
Schedule of Changes in Warrant Liabilities
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
Warrant liabilities as of January 1, 2023 | |
$ | — | | |
$ | — | | |
$ | 2,234,384 | |
Addition | |
| — | | |
| — | | |
| 2,446,502 | |
Changes in fair value of warrant liabilities | |
| — | | |
| — | | |
| (844,854 | ) |
Reclassify to equity | |
| — | | |
| — | | |
| (3,827,807 | ) |
Warrant liabilities as of December 31, 2023 | |
| — | | |
| — | | |
| 8,225 | |
Changes in fair value of warrant liabilities | |
| — | | |
| — | | |
| 9,284 | |
Warrant liabilities as of March 31, 2024 | |
| — | | |
| — | | |
| 17,509 | |
Changes in fair value of warrant liabilities | |
| — | | |
| — | | |
| (7,576 | ) |
Warrant liabilities as of June 30, 2024 | |
$ | — | | |
$ | — | | |
$ | 9,933 | |
11.
Derivative Liabilities
The
Company accounts for derivative financial instruments as either equity or liabilities in accordance with ASC Topic 815, Derivatives
and Hedging, or ASC 815, based on the characteristics and provisions of each instrument. Embedded derivatives are required to be
bifurcated from the host instruments and recorded at fair value if the derivatives are not clearly and closely related to the host instruments
on the date of issuance. Derivative instrument liabilities are classified in the balance sheets as current or non-current based on whether
or not net-cash settlement of the derivative instrument could be required within 12 months of the balance sheet date.
The
Company identified derivative instruments arising from the conversion shares from convertible notes in Note 4 as of December 31, 2023.
The
Company utilizes a Monte Carlo simulation model for commitment shares that have an option to convert at a variable number of shares to
compute the fair value of the derivative and to mark to market the fair value of the derivative at each balance sheet date. The inputs
utilized in the application of the Monte Carlo model included a starting stock price of $9.20 per share, an expected remaining term of
each warrant as of the valuation date, estimated volatility of 80%, drift, and a risk-free rate ranging from 3.46% to 5.47%.
Risk-free
interest rate: The Company uses the risk-free interest rate of a U.S. Treasury Note adjusted to be on a continuous return basis to align
with the Black-Scholes option-pricing model.
Dividend
yield: The Company uses a 0% expected dividend yield as the Company has not paid dividends to date and does not anticipate declaring
dividends in the near future.
Volatility:
The Company calculates the expected volatility based on comparable company’s historical stock prices with a look back period commensurate
with the period to maturity.
Expected
term: The Company’s remaining term is based on the remaining contractual maturity of the warrants.
The
following are the changes in the derivative liabilities during the year ended December 31, 2023.
Schedule of Changes in Derivative Liabilities
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
Derivative liabilities as of January 1, 2023 | |
$ | — | | |
$ | — | | |
$ | 1,735,700 | |
Addition | |
| — | | |
| — | | |
| 2,375,378 | |
Changes in fair value of derivative liabilities | |
| — | | |
| — | | |
| (198,551 | ) |
Extinguishment of derivative liabilities | |
| — | | |
| — | | |
| (3,912,527 | ) |
Derivative liabilities as of December 31, 2023 | |
$ | — | | |
$ | — | | |
$ | — | |
There
was no derivative liability activity for the three and six months ended June 30, 2024.
12.
Commitments and Contingencies
Manufacturing
Services Agreement
On
August 21, 2020, the Company entered into a Manufacturing Services Agreement (MSA) for the manufacture and supply of the Company’s
IB-STIM device based upon the Company’s product specifications as set forth in the MSA. This agreement terminated any prior manufacturing
agreements.
The
Company provides the necessary equipment to the manufacturer and retains ownership. The manufacturer bears the risk of loss of and damage
to the equipment and consigned materials. Performance under the MSA is initiated by orders issued by the Company and accepted by the
manufacturer.
The
term of the MSA is 24 months and shall automatically renew for renewal terms of twelve months unless either party provides a written
termination notice to the other party within 180 days prior to the end of the then-current term.
Trademark
Agreement
The
Company entered into an agreement for a trademark related to the Company’s name on July 11, 2022. The agreement called for an initial
payment of $10,000 upon execution of the agreement. A second and final payment of $40,000 was contingent upon the completion of the Company’s
planned initial public offering. The second payment has been accrued and is recorded in accounts payable and intangible assets on the
balance sheet. The trademark does not have a determinate life and therefore the cost is not being amortized.
Advisory
Agreement
On
March 18, 2024, the Company terminated its private placement services agreement and entered into an advisory agreement for debt, equity
and public securities market services for one year. The advisory agreement includes a monthly fee of $30,000 and 7,563 common stock warrants
to be issued monthly at an exercise price of $2.38 with a term of five years.
Settlement
Agreements
On June 28, 2024, the Company issued 90,032
shares of common stock to various pre-IPO Series A Preferred Stock shareholders to settle certain claims. The Company recorded the
fair value of the settlements totaling $286,458 as other expense in the Condensed Statements of Operations (See Note 6).
Furthermore,
the Company authorized the issuance of 104,378
shares of its common stock to settle remaining claims with pre-IPO Series A Preferred Stock shareholders classified as $290,171
of other expense for the three and six months ended June 30, 2024 in the Condensed Statements of Operations and accrued expenses in
the Condensed Balance Sheets as of June 30, 2024. These common shares have not yet been issued as of the reporting date as the Company
awaits execution of the settlement agreements by the counterparties.
Executive
Employment Agreements
The
Company, as authorized by the board of directors, entered into employment agreements with nine key employees to provide incentives to
improve shareholder value and to contribute to the growth and financial success of the Company. The agreements had an employment start
date of October 1, 2022, with initial terms from 2 to 5 years and optional one-year renewals.
The
total base salaries for the nine key employees in the agreements are $1,920,000 per year with various provisions for annual increases.
In addition to base salaries, eight of the employees have a provision for a special one-time incentive payment to be paid in a lump sum
after the start date. The total amount of these special incentive payments is $1,100,000. The special incentive payment amount includes
any accrued backpay wages for the employee. That amount for backpay was $417,390 and was paid in 2023.
There
are seven key employees that have stock options of the Company totaling 1,238,712 shares. These key employees have a provision in their
agreements whereas the Company will pay a special bonus equal to the aggregate of the strike price or exercise price of all their stock
options plus a tax gross-up payment. The special bonus shall be paid in twenty percent (20%) installments starting January 2, 2024, and
the same date each of the next four years. As a condition of the payment, the key employee must exercise at least 20% of their stated
number of stock options. There are additional provisions to cover termination and change of control events.
In
April 2023, the Company amended the employee agreements to, among other things, clarify that the special one-time incentive payment and
the deferred bonus are contingent upon the effective date of the planned initial public offering. The amendment also sets forth a process
for executives to exercise the stock options in accordance with the terms of the stock option agreement in effect as of the date of the
employment agreement and to clarify that there is no modification to the stock option agreements.
The
Company has recorded the backpay portion of the incentive bonus noted above. The balance of the incentive bonuses of $694,056 and the
special options bonuses of $14,821,830 were contingent upon a successful initial public offering. The incentive bonuses have been paid
in full while the special options bonuses will be recorded when paid.
On
April 10, 2024, the employment of the Company’s Chief Operating Officer was terminated. Pursuant to the employment agreement, the
Company will (i) make salary continuation payments based on an annual salary of $275,000 through October 10, 2024, (ii) provide health
care coverage through October 10, 2025, (iii) issue 25,832 shares of common stock at a fair value of $78,788 and (iv) make a $41,980
one-time payment in lieu of the exercise of 13,764 stock options that expired on January 2, 2024.
Litigation
From
time to time in the normal course of our business operations, we may become subject to litigation that may result in liability material
to our financial condition as a whole or may negatively affect our operating results if changes to our business operations are required.
The cost to defend such litigation may be significant and may require a significant diversion of our resources, and there is no guarantee
that we will be able to successfully defend against any such litigation regardless of particular merits. There also may be adverse publicity
associated with litigation that could negatively affect customer perception of our business, regardless of whether the allegations are
valid or whether we are ultimately found liable. Insurance may not be available on favorable terms, at all, or in sufficient amounts
to cover any liabilities with respect to these or other matters. A judgment or other liability in excess of our insurance coverage for
any claims could adversely affect our business, financial condition and the results of our operations.
On
February 6, 2019, plaintiff Ritu Bharnbhani, M.D., initiated a lawsuit against Innovative Health Solutions, Inc. and others in the United
States District Court for the District of Maryland. Plaintiffs Bhambhani and Sudhir Rao subsequently amended the complaint, with the
Third Amended Complaint (“Complaint”) containing the most recent set of allegations. The Complaint asserted claims under
the RICO Act, as well as of fraudulent misrepresentation, intentional misrepresentation by concealment, and civil conspiracy and sought
compensatory damages in excess of $5 million, pre-judgment interest, punitive damages, attorney’s fees, court costs and designation
of the case as a class action. The Complaint states that the Company, distributors of the Company’s product, and medical billing
and coding consultants allegedly made misrepresentations to the plaintiffs that the Company’s NeuroStim device and related procedures
could be billed to, and reimbursed by, Medicare and other insurance payors as a surgically implantable neurostimulator. Plaintiffs claim
to have suffered damages when Medicare administrative contractors declined to pay plaintiffs for their use of the device.
On
February 11, 2022, the Company filed a motion for summary judgment based upon the plaintiffs not being proper parties to assert claims
against the Company. On June 14, 2022, the Court granted the Company’s motion for summary judgment and dismissed the Complaint.
On
July 14, 2022, plaintiffs Ritu Bhambhani and Sudhir Rao filed a notice of appeal with the Fourth Circuit Court of Appeals. The Company
filed a motion to dismiss. On January 4, 2023, the Court issued an order that stated it was deferring a ruling on the motion to dismiss
the appeal and that it would address those arguments at the same time that it addressed the substantive merits of the case. As of May
5, 2023, the parties have submitted their appellate briefs to the Fourth Circuit. No date has been set for either oral argument or for
issuance of a decision by the court. While it is too early to predict the ultimate outcome of this matter, we continue to believe we
have meritorious defenses, that the dismissal of the Complaint should be upheld, and intend to continue to defend this matter vigorously.
On
July 14, 2022, plaintiffs Ritu Bhambhani, LLC; Box Hill Surgery Center, LLC; Pain and Spine Specialists of Maryland, LLC; and SimCare
ASC, LLC initiated a lawsuit against the Company and others in the United States District Court for the District of Maryland. The plaintiffs
in this lawsuit are business entities owned or partially owned by the plaintiffs that initiated the litigation described above. The Complaint
asserted claims under the RICO Act, as well as fraudulent misrepresentation, intentional misrepresentation by concealment, and civil
conspiracy and seeks compensatory damages in excess of $75,000, pre-judgment interest, punitive damages, attorney’s fees, and court
costs. The Complaint states that the Company, distributors of the Company’s product, and medical billing and coding consultants
allegedly made misrepresentations to the plaintiffs that the Company’s NeuroStim device and related procedures could be billed
to, and reimbursed by, Medicare and other insurance payors as a surgically implantable neurostimulator. Plaintiffs claim to have suffered
damages when Medicare administrative contractors declined to pay plaintiffs for their use of the device.
On
September 28, 2022, the Company filed a motion to dismiss all claims. On May 25, 2023, the Court issued an Order and a Memorandum Opinion
which dismissed the plaintiff’s claims related to the RICO Act. The remaining claims are still pending, and no trial date has been
set for the case.
The
Court has vacated its Scheduling Order at the parties’ request so that the parties could try to resolve the disputes in both cases
through an independent third-party mediator. No mediation date has been set. While it is too early to predict the ultimate outcome of
this matter, we believe the Company has meritorious defenses and intends to defend this matter vigorously.
13.
Subsequent Events
The Company has evaluated subsequent events through the filing of this Quarterly Report on Form 10-Q and determined that there have been
no events that have occurred that would require adjustments to our disclosures in the condensed financial statements.
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 unaudited financial
statements and the related notes appearing in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion
and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy
for our business and related financing, includes forward-looking statements that involve risks, uncertainties, and assumptions. You should
read the “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” sections of our
final prospectus filed with the United States Securities and Exchange Commission (the “SEC”) on August 11, 2023 pursuant
to Rule 424(b)(4) under the Securities Act of 1933, as amended (the “Prospectus”) (filed in connection with our IPO) for
a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the
forward-looking statements contained in the following discussion and analysis.
Overview
We
are a growth stage company focused on developing neuromodulation therapies to address chronic and debilitating conditions in children.
Our mission is to provide solutions that create value and provide better and safer patient outcomes. Our IB-Stim device is a PENFS system
intended to be used in patients 11-18 years of age with functional abdominal pain associated with IBS. Our device already has market
clearance from FDA for functional abdominal pain associated with IBS in children. Other indications in our pipeline are comprised of
functional nausea in children, post-concussion syndrome in children, and cyclic vomiting syndrome in children. For more information,
see “Business—Our Pipeline” and “—Products.”
Since
our inception, we have incurred significant operating losses. Our net loss was $2,917,710 and $2,235,614 for the three months ended June
30, 2024 and 2023, respectively, and $5,038,361 and $4,409,022 for the six months ended June 30, 2024 and 2023, respectively. As of June
30, 2024, we had an accumulated deficit of $5,258,382. Our auditors have expressed substantial doubt about our ability to continue as
a going concern in their audit opinion. We expect to incur significant expenses and operating losses for the foreseeable future as we
continue to pursue widespread insurance coverage of our IB-Stim device and seek FDA clearance of our device for other indications. There
are a number of milestones and conditions that we must satisfy before we will be able to generate sufficient revenue to fund our operations,
including FDA clearance of our IB-Stim device to treat future indications.
Factors
Affecting our Business and Results of Operations
Revenue
Our
revenue is derived from the sale of our IB-Stim device to healthcare companies, primarily hospitals and clinics. Sales generally are
not seasonal and only mildly correlated with economic cycles. Our IB-Stim device sells for $1,195 per device, and each child being treated
for functional abdominal pain associated with IBS will use three to four devices. Potential patients with future indications are expected
to use six or more devices per patient.
Our
sales typically are made on a purchase order basis rather than through long-term purchase commitments. We enter into sales agreements
with customers for IB-Stim devices based on purchase orders and standard terms, which vary slightly based on the customer’s form,
and conditions of sale. Standard payment terms generally are that payment is due within 30 days.
Inflation
did not have a material impact on our operations for any applicable period, and we do not expect inflation to have a material impact
on our operations for the foreseeable future.
Gross
Profit and Gross Margin
Our
management uses gross profit and gross margin to evaluate the efficiency of operations and as a key component to determining the effectiveness
and allocation of resources. We calculate gross profit as revenue less cost of goods sold, and gross margin as gross profit divided by
revenue. Our gross margin has been and will continue to be affected by a variety of factors, primarily the average selling price of our
IB-Stim device, production volume, order flows, change in mix of customers, third-party manufacturing costs related to components of
our IB-Stim device, and cost-reduction strategies. We expect our gross profit to increase for the foreseeable future as our revenue grows,
both through broader insurer acceptance of our IB-Stim device in the near term and approval of our technology for the treatment of other
indications over the longer term. Our gross margin may fluctuate from quarter to quarter due to changes in average selling prices, particularly
as we introduce enhancements to our IB-Stim device and new products to address other indications, and as we adopt new manufacturing processes
and technologies.
Expenses
We
have four categories of expenses: cost of goods sold, selling expenses, research and development, and general and administrative.
Costs
of goods sold consist of costs paid for the IB-Stim device to our contract manufacturer along with periodic inventory adjustments and
expired inventory write-offs. Expired inventory expense is related to our FDA clearance for our device in the treatment of functional
abdominal pain associated with IBS in children. Specifically, a certain component of our IB-Stim device is cleared for a two-year period
after the date the device is manufactured, and if the device is not sold in such period, we must take the device out of inventory and
write it off. We had no expired inventory for the three and six months ended June 30, 2024 and 2023.
Expired inventory has not been material to our results. We have a fixed-price
contract with the manufacturer of our IB-Stim device to produce the device. We expect production costs to remain relatively constant
and only nominal inventory expirations in the foreseeable future.
Our
core selling expenses primarily consist of commissions and shipping costs. These expense items are generally correlated with sales.
Research
and development expense is attributable to our clinical trials and related efforts to have our IB-Stim device cleared by the FDA for
other indications. We expect to incur future R&D expenses for other indications, such as functional nausea, post-concussion syndrome
and cyclic vomiting syndrome in children.
General
and administrative expense primarily consists of wages and benefits, professional fees including legal and audit, insurance, investor
relations, advertising, facility costs, utilities and travel.
Results
of Operations
The
following table presents our statements of operations for the three and six months ended June 30, 2024 and 2023, respectively:
| |
(Unaudited) | | |
(Unaudited) | |
| |
Three
Months Ended June 30, | | |
Six
Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Net
sales | |
$ | 611,500 | | |
$ | 646,021 | | |
$ | 1,258,135 | | |
$ | 1,451,131 | |
Cost
of goods sold | |
| 73,458 | | |
| 67,813 | | |
| 148,539 | | |
| 163,713 | |
Gross
profit | |
| 538,042 | | |
| 578,208 | | |
| 1,109,596 | | |
| 1,287,418 | |
Selling
expenses | |
| 62,274 | | |
| 78,791 | | |
| 142,304 | | |
| 186,723 | |
Research
and development | |
| 54,312 | | |
| 109,789 | | |
| 59,882 | | |
| 126,586 | |
General
and administrative | |
| 2,628,288 | | |
| 1,507,169 | | |
| 4,946,362 | | |
| 2,987,923 | |
Operating
loss | |
| (2,206,832 | ) | |
| (1,117,541 | ) | |
| (4,038,952 | ) | |
| (2,013,814 | ) |
Other
(expense) income: | |
| | | |
| | | |
| | | |
| | |
Financing
charges | |
| - | | |
| - | | |
| (230,824 | ) | |
| (2,772 | ) |
Interest
expense | |
| (80,697 | ) | |
| (194,690 | ) | |
| (107,257 | ) | |
| (356,378 | ) |
Change
in fair value of warrant liability | |
| 7,576 | | |
| (36,050 | ) | |
| (1,708 | ) | |
| 198,757 | |
Change
in fair value of derivative financial instruments | |
| - | | |
| 860 | | |
| - | | |
| 192,157 | |
Amortization
of debt discount and issuance costs | |
| (63,817 | ) | |
| (887,937 | ) | |
| (85,500 | ) | |
| (3,550,592 | ) |
Extinguishment
of debt liabilities | |
| - | | |
| - | | |
| - | | |
| 1,129,498 | |
Other
income | |
| 2,961 | | |
| 2 | | |
| 2,961 | | |
| 1,552 | |
Other
expense | |
| (576,901 | ) | |
| (258 | ) | |
| (577,081 | ) | |
| (7,430 | ) |
Total
other expense, net | |
| (710,878 | ) | |
| (1,118,073 | ) | |
| (999,409 | ) | |
| (2,395,208 | ) |
Net
loss | |
$ | (2,917,710 | ) | |
$ | (2,235,614 | ) | |
$ | (5,038,361 | ) | |
$ | (4,409,022 | ) |
Net
Sales
Net
sales decreased $34,521, or 5.3%, from $646,021 for the three months ended June 30, 2023, to $611,500 for the three months ended June
30, 2024. Net sales decreased $192,996, or 13.3%, from $1,451,131 for the six months ended June 30, 2023, to $1,258,135 for the six months
ended June 30, 2024. The decreases were primarily due to (i) management’s focus on gaining further insurance coverage for our products
and capital funding and (ii) fewer shipments to certain customers as they transition to the insurance reimbursement process which requires
alignment with physician protocols, billing and coding, partially offset by growth in our financial assistance programs that provide
discounts to patients without insurance coverage.
Gross
Profit and Gross Margin
Gross
profit decreased $40,166, or 6.9%, from $578,208 for the three months ended June 30, 2023, to $538,042 for the three months ended June
30, 2024; gross margin was 88.0% and 89.5% for the three months ended June 30, 2024 and 2023, respectively. Gross profit decreased $177,822,
or 13.8%, from $1,287,418 for the six months ended June 30, 2023, to $1,109,596 for the six months ended June 30, 2024; gross margin
was 88.2% and 88.7% for the six months ended June 30, 2024 and 2023, respectively. The decreases were due to (i) lower sales volume to
certain customers as they transition through the full reimbursement insurance process and (ii) lower gross margin due to growth in our
financial assistance programs that are discounted to patients without insurance coverage.
Selling
Expenses
Selling
expenses decreased $16,517, or 21.0%, from $78,791 for the three months ended June 30, 2023, to $62,274 for the three months ended June
30, 2024. Selling expenses decreased $44,419, or 23.8%, from $186,723 for the six months ended in the six months ended June 30, 2023,
to $142,304 for the six months ended June 30, 2024. The decreases were due to lower sales volume.
Research
and Development
Research
and development expenses decreased $55,477, or 50.5%, from $109,789 for the three months ended June 30, 2023, to $54,312 for the three
months ended June 30, 2024. Research and development expenses decreased $66,704, or 52.7%, from $126,586 for the six months ended June
30, 2023 to $59,882 for the six months ended June 30, 2024. The decreases were due to more patient trials conducted in 2023 as the
company prepared for more FDA submissions.
General
and Administrative
General
and administrative expenses increased $1,121,119, or 74.4%, from $1,507,169 for the three months ended June 30, 2023, to $2,628,288 for
the three months ended June 30, 2024 primarily due to (i) higher legal, insurance, investor relation and board of director costs as a
publicly held entity that the Company did not incur prior to its IPO, (ii) incremental headcount to build out the market access, sales
and finance teams including recruiting costs, (iii) a severance charge related to the Company’s prior Chief Operating Officer,
(iv) one-time non-cash advisory costs of $105,600, (v) expenses related to the introduction of an annual short-term incentive bonus program,
and (vi) higher advertising costs in order to expand market awareness.
General
and administrative expenses increased $1,958,439, or 65.5%, from $2,987,923 for the six months ended June 30, 2023, to $4,946,362 for
the six months ended June 30, 2024 primarily due to (i) higher legal, insurance, investor relation and board of director costs as a
publicly held entity that the Company did not incur prior to its IPO, (ii) incremental headcount to build out the market access, sales
and finance teams including recruiting costs, (iii) a severance charge related to the Company’s prior Chief Operating Officer,
(iv) one-time non-cash advisory costs of $155,600, (v) a one-time non-cash stock compensation charge of $227,000 for a hiring grant of
stock, (vi) expenses related to the introduction of an annual short-term incentive bonus program, and (vii) higher advertising costs
in order to expand market awareness.
Operating
Loss
Our
operating loss increased $1,089,291, or 97.5%, from $1,117,541 for the three months ended June 30, 2023, to $2,206,832 for the three
months ended June 30, 2024. Our operating loss increased $2,025,138, or 100.6%, from $2,013,814 for the six months ended June 30,
2023, to $4,038,952 for the six months ended June 30, 2024. The increases were primarily due to lower sales volume, lower gross
margin as the Company’s discounted financial assistance program grows and higher general and administrative
expenses.
Other
(Expense) Income, Net
Other
expense decreased $407,195, or 36.4%, from $1,118,073 for the three months ended June 30, 2023, to $710,878 for the three months
ended June 30, 2024 primarily due to (i) the full conversion of the convertible notes upon the IPO on August 9, 2023, that
eliminated any further debt discount, issuance cost and fair value derivative valuation net charges and (ii) lower interest expense
and issuance cost amortization from a lower debt burden, partially offset the settlement of certain claims of pre-IPO Series A
Preferred Stock shareholders.
Other
expense decreased $1,395,799, or 58.3%, from $2,395,208 for the six months ended June 30, 2023, to $999,409 for the six months ended
June 30, 2024 primarily due to (i) the full conversion of the convertible notes upon the IPO on August 9, 2023, that eliminated any further
debt discount, issuance cost, debt extinguishment and fair value derivative valuation net charges and (ii) lower interest expense and
issuance cost amortization from a lower debt burden, partially offset by finance charges incurred to settle a 2023 convertible note dispute
and other expense to settle certain claims of pre-IPO Series A Preferred Stock shareholders.
Net
Loss
Our
net loss increased $682,096, or 30.5%, from $2,235,614 for the three months ended June 30, 2023, to $2,917,710 for the three months ended
June 30, 2024. Our net loss increased $629,339, or 14.3%, from $4,409,022 for the six months ended June 30, 2023, to $5,038,361 for the
six months ended June 30, 2024. The increases were primarily due to (i) higher general and administrative expenses and (ii) the settlements
of a 2023 convertible note dispute and certain pre-IPO Series A Preferred Stock shareholders claims, partially offset
by the elimination of debt discount, issuance costs, debt extinguishment and derivative fair valuation net charges.
Liquidity
and Capital Resources
We
had cash on hand of $1,765,274 and $51,440 as June 30, 2024 and 2023, respectively. We maintained a working capital deficit of $5,482,316
and $1,643,058 as of June 30, 2024 and December 31, 2023, respectively. The decrease in working capital was primarily due to the issuance
of $4,935,000 of convertible notes during the six months ended June 30, 2024, net of cash on hand as of June 30, 2024.
We
have incurred losses since inception and have funded our operations primarily with a combination of sales, debt, and the sale of
capital stock. As of June 30, 2024, we had a stockholders’ deficit of $5,258,382 and short-term borrowings of $4,767,335, net
of financing fees.
Our
future capital requirements will depend upon many factors, including progress with developing, manufacturing, and marketing our technologies,
the time and costs involved in preparing, filing, prosecuting, maintaining, and enforcing patent claims and other proprietary rights,
our ability to establish collaborative arrangements, marketing activities and competing technological and market developments, including
regulatory changes and overall economic conditions in our target markets. Our ability to generate revenue and achieve profitability requires
us to successfully market and secure purchase orders for our products from customers currently identified in our sales pipeline and to
new customers as well. The primary activity that will drive all customers and revenues is the adoption of insurance coverage by commercial
insurance carriers nationally, so this is a top priority of the Company. These activities, including our planned research and development
efforts, will require significant uses of working capital through the rest of 2024 and beyond. Based on our current operating plans,
we believe that our existing cash at the time of this filing will only be sufficient to meet our anticipated operating needs through
the end of 2024.
Additionally,
we will have to meet all the financial disclosure and reporting requirements associated with being a publicly reporting company. Our
management will have to spend additional time on policies and procedures to make sure it is compliant with various regulatory requirements,
especially that of Section 404 of the Sarbanes-Oxley Act. This additional corporate governance time required of management could limit
the amount of time our management has to implement our business plan and may delay our anticipated growth plans.
The
following table summarizes our cash flow from operating, investing and financing activities for the six months ended June 30, 2024 and
2023:
| |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
Net cash used in operating activities | |
$ | (2,947,295 | ) | |
$ | (1,248,137 | ) |
Net cash used in investing activities | |
| (23,408 | ) | |
| (13,067 | ) |
Net cash provided by financing activities | |
| 4,657,417 | | |
| 1,058,945 | |
Net increase (decrease) in cash and cash equivalents | |
| 1,686,714 | | |
| (202,259 | ) |
Cash and cash equivalents at beginning of period | |
| 78,560 | | |
| 253,699 | |
Cash and cash equivalents at end of period | |
$ | 1,765,274 | | |
$ | 51,440 | |
Operating
Activities – Net cash used in operating activities increased $1,699,158, or 136.1% for the six months ended June 30, 2024 compared
to the six months ended June 30, 2023 primarily due to lower sales volume, higher general and administrative expenses and payments of
past due vendors.
Investing
Activities – Net cash used in investing activities increased $10,341, or 79.1%, for the six months ended June 30, 2024
compared to the six months ended June 30, 2023 due to purchases of equipment.
Financing
Activities – Net cash provided by financing activities increased $3,598,472, or 339.8%, for the six months ended June 30, 2024
compared to the six months ended June 30, 2023 primarily due to proceeds from the issuance of convertible notes whereas the proceeds
from convertible notes issued during the six months ended June 30, 2023 were used to repay previously issued notes payable.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
applicable.
ITEM
4. CONTROLS AND PROCEDURES
Evaluation
of Application of U.S. GAAP and Disclosure Controls and Procedures
Our
management has evaluated, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer,
the effectiveness of our (i) controls over the application of U.S. GAAP based on guidance and interpretations issued by the Financial
Accounting Standards Board through the Accounting Standards Codification and Accounting Standards Updates and (ii) disclosure controls
and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) as of the end of the period covered
by this report. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of June 30,
2024, our U.S. GAAP reporting and disclosure controls and procedures were not effectiv