Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
Neuraxis,
Inc.
Condensed
Balance Sheet
June 30,
2023
(Unaudited)
December 31,
2022
Assets
Current Assets:
Cash and cash equivalents
$ 51,440
$ 253,699
Accounts receivable, net
237,170
174,399
Inventories
44,205
48,133
Prepaids and other current assets
21,333
726
Total current assets
354,148
476,957
Property and Equipment, at cost:
417,912
405,845
Less - accumulated depreciation
( 332,651 )
( 317,834 )
Property and equipment, net
85,261
88,011
Other Assets:
Deferred offering costs
941,143
736,736
Operating lease right of use asset
85,823
101,382
Intangible assets, net
73,316
77,558
Total Assets
$ 1,539,691
$ 1,480,644
Liabilities
Current Liabilities:
Accounts payable
$ 2,438,117
$ 1,592,116
Accrued expenses
1,174,381
834,062
Notes payable
249,389
202,834
Current portion of operating lease payable
41,261
33,395
Notes payable - related party
58,051
58,051
Notes payable
58,051
58,051
Notes payable - convertible notes, net of unamortized discount of $ 4,421,424 and $ 3,327,213 as of June 30, 2023 and December 31, 2022
1,217,465
228,342
Customer deposits
61,317
59,174
Derivative liabilities
2,275,029
1,735,700
Warrant liabilities
3,916,884
2,234,384
Total current liabilities
11,431,894
6,978,058
Non-current Liabilities:
Operating lease payable, net of current portion
51,635
76,199
Note payable, net of current portion
38,797
—
Total non-current liabilities
90,432
76,199
Total liabilities
11,522,326
7,054,257
Commitments and contingencies (see note 14)
-
-
Stockholders’ Deficit
Convertible Series A Preferred stock, $ 0.001 par value; 1,000,000 shares authorized; 506,637 issued and outstanding as of June 30, 2023 and December 31, 2022
507
507
Convertible Series Seed Preferred Stock, $ 0.001 par value; 120,000 shares authorized; 115,477 issued and outstanding as of June 30, 2023 and December 31, 2022
115
115
Preferred stock value
115
115
Common stock, $ 0.001 par value; 100,000,000 shares authorized; 1,963,322 issued and outstanding as of June 30, 2023 and December 31, 2022
1,963
1,963
Additional paid in capital
28,355,230
28,355,230
Accumulated deficit
( 38,340,450 )
( 33,931,428 )
Total stockholders’ deficit
( 9,982,635 )
( 5,573,613 )
Total Liabilities and Stockholders’ Deficit
$ 1,539,691
$ 1,480,644
The accompanying notes
are an integral part of these unaudited condensed financial statements.
3
Neuraxis,
Inc.
Condensed
Statements of Operations (Unaudited)
2023
2022
2023
2022
For the Three Months Ended
June 30,
For the Six Months Ended
June 30,
2023
2022
2023
2022
Net Sales
$ 646,021
$ 682,581
$ 1,451,131
$ 1,452,848
Cost of Goods Sold
67,813
79,009
163,713
154,209
Gross Profit
578,208
603,572
1,287,418
1,298,639
Selling Expenses
78,791
127,424
186,723
263,304
Research and Development
109,789
13,665
126,586
58,063
General and Administrative
1,507,169
1,132,065
2,987,923
2,160,161
Operating Loss
( 1,117,541 )
( 669,582 )
( 2,013,814 )
( 1,182,889 )
Other Income (Expense):
Financing charges
—
( 872,763 )
( 2,772 )
( 872,763 )
Interest expense
( 194,690 )
( 34,450 )
( 356,378 )
( 60,550 )
Change in fair value of warrant liability
( 36,050 )
61,520
198,757
( 569,561 )
Change in fair value of derivative liability
860
—
192,157
—
Amortization of debt discount and issuance cost
( 887,937 )
( 12,944 )
( 3,550,592 )
( 12,944 )
Extinguishment of debt liabilities
—
—
1,129,498
—
Other income
2
11,689
1,552
11,956
Other expense
( 258 )
—
( 7,430 )
—
Total other income (expense), net
( 1,118,073 )
( 846,948 )
( 2,395,208 )
( 1,503,862 )
Net Loss
$ ( 2,235,614 )
$ ( 1,516,530 )
$ ( 4,409,022 )
$ ( 2,686,751 )
Per-share Data
Basic and diluted loss per share
$ ( 1.21 )
$ ( 0.87 )
$ ( 2.39 )
$ ( 1.56 )
Weighted Average Shares Outstanding
Basic and diluted
2,003,322
1,970,054
2,003,322
1,970,054
The accompanying notes are an integral part of these unaudited
condensed financial statements.
4
Neuraxis,
Inc.
Statements
of Stockholders’ Deficit
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
Deficit
For the Three and Six Months Ended June 30, 2022
Convertible Series A Preferred Stock
Convertible Series Seed Preferred Stock
Common Stock
Additional Paid In
Accumulated
Stockholder’s
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
Deficit
Balances, January 1, 2022
506,637
$ 507
115,477
$ 115
1,928,004
$ 1,928
$ 28,323,157
$ ( 29,151,367 )
$ ( 825,660 )
Stock based compensation
—
—
—
—
—
—
11,994
—
11,994
Net loss
—
—
—
—
—
—
—
( 1,170,221 )
( 1,170,221 )
Balances, March 31, 2022
506,637
$ 507
115,477
$ 115
1,928,004
$ 1,928
$ 28,335,151
$ ( 30,321,588 )
$ ( 1,983,887 )
Stock based compensation
—
—
—
—
—
—
12,127
—
12,127
Common stock issued upon signing of notes payable
—
—
—
—
14,125
14
1,034
1,048
Net loss
—
—
—
—
—
—
—
( 1,516,530 )
( 1,516,530 )
Balances, June 30, 2022
506,637
$ 507
115,477
$ 115
1,942,129
$ 1,942
$ 28,348,312
$ ( 31,838,117 )
$ ( 3,487,242 )
For the Three and Six Months Ended June 30, 2023
Convertible Series A Preferred Stock
Convertible Series Seed Preferred Stock
Common Stock
Additional Paid In
Accumulated
Stockholder’s
Shares
Amount
Shares
Amount
Shares
Amount
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 )
Balance, value
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 )
Balances, value
506,637
$ 507
115,477
$ 115
1,963,322
$ 1,963
$ 28,355,230
$ ( 38,340,450 )
$ ( 9,982,635 )
The accompanying notes are an integral part of these unaudited
condensed financial statements.
5
Neuraxis,
Inc.
Condensed
Statement of Cash Flows (Unaudited)
2023
2022
For the Six Months Ended June 30,
2023
2022
Cash Flows from Operating Activities
Net Loss
$ ( 4,409,022 )
$ ( 2,686,751 )
Adjustments to reconcile net loss to net
cash used by operating activities:
Adjustments to reconcile net loss to net cash used by operating activities:
Amortization of debt discount and issuance cost
3,550,592
12,944
Depreciation and amortization
20,060
16,695
Provisions for losses on accounts receivable
3,927
29,580
Non-cash lease expense
15,559
13,296
Stock based compensation
—
24,121
Extinguishment of debt liability
( 1,129,498 )
—
Finance Charges
2,772
872,763
Change in fair value of derivative liabilities
( 192,157 )
—
Change in fair value of warrant liabilities
( 198,757 )
569,561
Changes in operating assets and liabilities:
Accounts receivable
( 66,698 )
( 131,764 )
Inventory
3,928
( 13,616 )
Prepaids and other current assets
( 20,607 )
( 138 )
Accounts payable
846,001
( 118,561 )
Accrued expenses
340,318
266,486
Customer deposits
2,143
( 12,720 )
Operating lease liability
( 16,698 )
( 13,791 )
Net cash used by operating activities
( 1,248,137 )
( 1,171,895 )
Cash Flows from Investing Activities
Additions to property and equipment
( 12,067 )
—
Additions to intangible assets
( 1,000 )
( 49,815 )
Net cash used by investing activities
( 13,067 )
( 49,815 )
Cash Flows from Financing Activities
Principal payments on notes payable
( 2,724,479 )
( 86,453 )
Proceeds from notes payable
159,831
—
Proceeds from convertible notes, net of fees
3,828,000
1,087,500
Offering costs paid
( 204,407 )
( 26,549 )
Net cash used in financing activities
1,058,945
974,498
Net Decrease in Cash and Cash Equivalents
( 202,259 )
( 247,212 )
Cash and Cash Equivalents at Beginning of Period
253,699
320,858
Cash and Cash Equivalents at End of Period
$ 51,440
$ 73,646
Supplemental Disclosure of Non-cash Cash Activities
Cash paid for interest
$ 57,202
$ 55,550
Cash paid for income taxes
—
—
Supplemental Schedule of Non-cash Investing and Financing Activities
Fair value of warrant liabilities of warrants from convertible notes
$ 1,881,257
$ 884,118
Fair value of derivative liabilities of conversion feature from convertible notes
1,860,984
1,075,098
The accompanying notes are an integral part of these unaudited
condensed financial statements.
6
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
September 7, 2021, the Company’s board of directors authorized a 4-for-1 stock split . They also increased the number of authorized
common stock shares from 2,700,000 to 10,800,000 . Furthermore, on September 9, 2021, the board authorized an increase of authorized shares
of common stock from 10,800,000 to 13,400,000 in anticipation of a capital offering. Furthermore, 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.
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.
2.
Summary of Significant Accounting Policies
The
summary of significant accounting policies of Neuraxis, Inc. is presented to assist in understanding the Company’s financial statements.
The financial statements and notes are representations of the Company’s management, who is responsible for their integrity and
objectivity. These accounting policies conform to U.S. generally accepted accounting principles and have been consistently applied in
the preparation of the financial statements.
Preparing
the Company’s financial statements in conformity with accounting principles generally accepted in the United States of America
(“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 date of the financial statements and the reported amounts of revenues and
expenses during the reporting period.
7
Basis
of Presentation
The
Company’s condensed 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, consisting only of normal recurring adjustments,
which are necessary for a fair statement of the Company’s financial information. These interim results are not necessarily indicative
of the results to be expected for the year ending December 31, 2023, or any other interim period or for any other future year. These
unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements and the
notes thereto for the year ended December 31, 2022.
Use
of Estimates and Critical Accounting Estimates and Assumptions
The
preparation of financial statements in conformity with 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 doubtful
accounts, stock-based compensation, income tax provisions, excess and obsolete inventory reserve, and impairment of intellectual property.
Actual results could differ from those estimates.
Cash
and Cash Equivalents
The
Company considers all highly liquid debt instruments purchased with a maturity of three months or less to be cash equivalents. The Company
did not hold any cash equivalents as of June 30, 2023 and December 31, 2022.
Trade
Accounts Receivable
Trade
accounts receivable are stated at the amount management expects to collect from balances outstanding at year-end. Management considers
the following factors when determining the collectability of specific customer accounts: customer creditworthiness, past transaction
history with the customer, current economic industry trends, and changes in customer payment terms. Based on management’s assessment
of the credit history with customers having outstanding balances and current relationships with them, it has concluded that realization
losses on balances outstanding at year-end will be immaterial. Interest is not charged on past due customer accounts.
Allowance
for Credit Losses
Trade
accounts receivable are stated net of an allowance for credit losses. We estimate allowance for credit losses by evaluating specific
accounts where information indicates our customers may have an inability to meet financial obligations, such as customer payment history,
credit worthiness and receivable amounts outstanding for an extended period beyond contractual terms. We use assumptions and judgment,
based on the best available facts and circumstances, to record an allowance to reduce the receivable to the amount expected to be collected.
The allowance for doubtful accounts was $ 15,989 and $ 31,275 at June 30, 2023 and December 31, 2022, respectively. The Company recorded
bad debt expense for the three and six months ended June 30, 2023 of $ 7,714 and $ 3,927 , respectively, and for the three and six months
ended June 30, 2022 of $ 21,307 and $ 29,580 , respectively.
8
Customer
Deposits
Customer
deposits consists of billings, payments, and returned devices from clients in advance of revenue recognition. The Company will recognize
the customer deposits over the next year. As of June 30, 2023, and December 31, 2022, the Company had customer deposits of $ 61,317 and
$ 59,174 , respectively.
Inventories
Inventories
are valued at the lower of cost or net realizable value. Cost is determined using the weighted average method. The inventory is
comprised of finished medical devices on hand. Certain components within the devices have an expiration date that are removed from
current inventory and expensed at the date of expiration. For the six months ended June 30, 2023 there was no expired inventory, and
for the year ended December 31, 2022, there was $ 10,026 .
Deferred
Offering Costs
Deferred
offering costs consist of costs incurred in connection with the preparation of an initial public offering. These costs, together with
the underwriting discounts and commissions, will be charged to additional paid in capital upon completion of the proposed public offering.
As of June 30, 2023 and December 31, 2022, the Company had deferred offering costs of $ 941,143 and $ 736,736 , respectively.
Property
and Equipment
Property
and equipment are recorded at cost less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated
useful lives of the assets.
Depreciation
is calculated using the following estimated useful lives:
Schedule
of Estimated Useful Lives
Classification
Years
Leasehold Improvements
10 - 20
Machinery
and Equipment
7 - 10
Furniture
and Fixtures
5 - 10
Depreciation
expense was $ 7,589 and $ 14,817 during the three and six months ended June 30, 2023, respectively, and was $ 7,830 and $ 15,725 during the
three and six months ended June 30, 2022, respectively.
Research
and Development
Costs
for research and development are expensed as incurred. Research and development expenses consist primarily of clinical research studies,
and new product development.
Intangible
Assets
Intangible
assets consist of patents and a trademark. Patents are stated at their historical cost and amortized on a straight-line basis over their
expected useful lives. Capitalized patent costs, net of accumulated amortization, includes legal costs incurred for patent applications.
In accordance with ASC 350, once a patent is granted, we amortize the capitalized patent costs over the remaining life of the patent
using the straight-line method. If the patent is not granted, we write-off any capitalized patent costs at that time.
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 is contingent upon the completion of the Company’s
planned initial public offering. The second payment has not been recorded in these financial statements. The trademark does not have
a determinate life and therefore the cost is not being amortized. See Note 17 Subsequent Events.
9
The
Company entered into an option agreement on April 12, 2023 to enter into a royalty-bearing licensing agreement to bring the optionor’s
invention to commercialization. The agreement required an initial payment of $ 1,000 upon execution of the agreement. The agreement does
not have a determinate life and therefore the cost is not being amortized.
We
review intangible assets for impairment annually or when events or circumstances indicate that their carrying amount may not be
recoverable. During the three and six months ended June 30, 2023 and 2022, the Company recorded no impairment charges for intangible
assets.
Amortization
expense was $ 2,621 and $ 5,243 during the three and six months ended June 30, 2023, respectively, and was $ 485 and $ 970 during the three
and six months ended June 30, 2022, respectively.
Income
Taxes
The
Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in
the Company’s financial statements and tax returns. Deferred tax assets and liabilities are determined based upon the differences
between the financial statement carrying amounts, and the tax bases of existing assets and liabilities for the loss and credit carryforwards
using enacted tax rates expected to be in effect in the year in which the differences are expected to reverse. Deferred tax assets are
reduced by a valuation allowance if it is more likely than not that these assets may not be realized. The Company determines whether
a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit
attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more likely than not
recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency.
The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes.
Based
on the results of management’s evaluation, adoption of the rules did not have a material effect on the Company’s financial
statements. Further, no interest or penalties have been accrued or charged to expense as of June 30, 2023 and 2022 and for the six months
then ended.
The
Company’s income tax returns are subject to examination by the taxing authorities until the expiration of the related statutes
of limitations on those tax returns. In general, the federal and state income tax return have a three-year statute of limitations. As
of June 30, 2023, the following tax years are subject to examination:
Jurisdiction
Open
Years for Filed Returns
Federal
2020
– 2022
Various
States
2020
– 2022
Advertising
Cost
Advertising
costs are expensed as incurred and amounted to $ 24,986 and $ 32,986 for the three and six months ended June 30, 2023, respectively, and
$ 3,300 and $ 11,600 for the three and six months ended June 30, 2022, respectively.
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.
10
Warrant
Liabilities
Management
evaluates all of the Company’s financial instruments, including issued Warrants to purchase its Class A common 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.
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, 2023 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.
Unobservable inputs used in the models are significant to the fair values of the assets and liabilities.
11
The
following tables provides a summary of the relevant assets and liabilities that are measured at fair value on recurring basis:
Fair
Value Measurements as of
June
30, 2023
Schedule
of Fair Value On a Recurring Basis Assets and Liability
Total
(Level 1)
(Level 2)
(Level 3)
Liabilities:
Warrant liabilities
$ 3,916,884
$ —
$ —
$ 3,916,884
Derivative liabilities
$ 2,275,029
$ —
$ —
$ 2,275,029
Total Liabilities
$ 6,191,913
$ —
$ —
$ 6,191,913
Fair
Value Measurements as of
December
31, 2022
Total
(Level 1)
(Level 2)
(Level 3)
Liabilities:
Warrant liabilities
$ 2,234,384
$ —
$ —
$ 2,234,384
Derivative liabilities
$ 1,735,700
$ —
$ —
$ 1,735,700
Total Liabilities
$ 3,970,084
$ —
$ —
$ 3,970,084
The
following table shows the valuation methodology and unobservable inputs for Level 3 assets and liabilities measured at fair value on
recurring basis as of June 30, 2023 and December 31, 2022:
Schedule
of Unobservable Inputs for Level 3 Assets and Liabilities
As of Fair Value
As of Fair Value
Valuation
Unobservable
June 30 2023
December 31 2022
Methodology
Inputs
Warrant liabilities
$ 3,916,884
$ 2,234,384
Monte Carlo model
Project simulated cash flows
Derivative liabilities
$ 2,275,029
$ 1,735,700
Monte Carlo model
Project simulated cash flows
There
were no transfers between any of the levels during the three and six months ended June 30, 2023 and year ended December 31, 2022. 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. Generally, assets are recorded at fair value on a nonrecurring basis as a
result of impairment charges.
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. Basic weighted average shares for the quarter ended June 30, 2023 includes
40,000 vested warrants to purchase common shares. As the shares underlying these warrants can be purchased for little to no consideration
($ 0.01 per share exercise price), they are included in the computation of basic earnings per share. 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. Preferred stock dividends (not declared or paid) were $ 2,569,405 and $ 2,190,102 as of June 30, 2023 and December 31, 2022,
respectively.
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, 2023 and 2022 presented in these financial statements, the weighted-average number of common shares outstanding
excludes common stock equivalents because their inclusion would be anti-dilutive.
12
The
Company had the following potentially dilutive common stock equivalents at June 30, 2023 and 2022:
Schedule
of Dilutive Common Stock Equivalents
2023
2022
Convertible Series A Preferred Stock
1,013,270
1,013,270
Convertible Series Seed Preferred Stock
230,954
230,954
Options
1,319,394
1,319,394
Pre-Funded Warrants for Convertible Series A
Preferred Stock
289,779
289,779
Warrants
854,795
154,096
Convertible Bridge Debt
1,285,877
46,029
Totals
4,994,069
3,053,522
The
following table shows 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
2023
2022
2023
2022
For the Three Months Ended
June 30,
For the Six Months Ended
June 30,
2023
2022
2023
2022
Numerator
Net loss
$ ( 2,235,614 )
( 1,516,530 )
$ ( 4,409,022 )
( 2,686,751 )
Preferred stock dividends
( 190,699 )
( 190,699 )
( 379,303 )
( 379,303 )
Net income (loss) available to common stockholders
( 2,426,313 )
( 1,707,229 )
( 4,788,325 )
( 3,066,054 )
Denominator
Weighted-average shares of common stock
outstanding - basic and diluted
2,003,322
1,970,054
2,003,322
1,970,054
Basic and diluted net loss per share
$ ( 1.21 )
$ ( 0.87 )
$ ( 2.39 )
$ ( 1.56 )
Stock-Based
Compensation
The
Company accounts for all stock-based payments and awards under the fair value-based method. The Company recognizes its stock-based compensation
expense using the straight-line method. Compensation cost is not adjusted for estimated forfeitures, but instead is adjusted upon an
actual forfeiture of a stock option.
The
Company accounts for the granting of stock options to employees and non-employees using the fair value method whereby all awards are
measured at fair value on the date of the grant. The fair value of all employee stock options is expensed over the requisite service
period with a corresponding increase to additional paid-in capital. Upon exercise of stock options, the consideration paid by the option
holder is recorded in additional paid-in capital, while the par value of the shares received is reclassified from additional paid in
capital to common stock.
Stock-based
payments to non-employees are measured based on the fair value of the equity instrument issued. Compensation expense for non-employee
stock awards is recognized over the requisite service period following the measurement of the fair value on the grant date.
The
Company uses the Black-Scholes option-pricing model to calculate the fair value of stock options. The use of the Black-Scholes option-pricing
model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common
stock consistent with the expected term of the option, risk-free interest rates, the value of the common stock and expected dividend
yield of the common stock. Changes in these assumptions can materially affect the fair value estimate.
13
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, 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 of 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 table disaggregates the Company’s revenue based on the customer’s location by state for the three months ended June
30:
Schedule
of Disaggregation of Revenue
2023
2022
California
$ 162,700
Wisconsin
$ 166,640
Wisconsin
87,600
Ohio
122,600
Illinois
53,105
California
115,930
Florida
52,580
Florida
97,815
Missouri
45,020
Missouri
33,460
All other states
245,016
All other states
146,136
$ 646,021
$ 682,581
The following table disaggregates the Company’s revenue based on the customer’s location by state for
the six months ended June 30:
2023
2022
California
$
375,320
Wisconsin
$
433,620
Wisconsin
198,640
Ohio
252,270
Ohio
149,300
California
192,905
Florida
97,600
Florida
107,375
Missouri
94,430
Missouri
81,260
All other states
535,841
All other states
385,418
$
1,451,131
$
1,452,848
14
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).
The
opening and closing balances of trade receivables, contract assets, and contract liabilities from contracts with customers are as follows:
Schedule
of Trade Receivables Contract Assets and Contract Liabilities
Trade Receivables
Contract Assets
Contract Liabilities
Balance 1/1/2022
$ 115,301
$ 0
$ 0
Balance 12/31/22 and 1/1/2023
$ 174,399
$ 0
$ 0
Balance 6/30/2023
$ 237,170
$ 0
$ 0
Company’s
Performance Obligations with Customers:
Timing
of Satisfaction
The
Company typically satisfies its performance obligations as the goods are delivered.
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). In some cases,
a customer will take delivery directly from the Company’s inventory (i.e., consigned inventory), at which point ownership and the
associated risks pass to the customer at that time.
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).
15
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.
Warranties
In
most cases, goods that customers purchase from the Company are covered by manufacturers’ warranties. The Company does not sell
warranties separately.
The
manufacturer guarantees the product for the period up to the expiration date printed on the device’s label or twelve months from
the date of purchase, whichever comes first. The guarantee applies to flaws of material and workmanship. The Company’s warranties
provide customers with assurance that purchased devices comply with published specifications, inspection standards, and workmanship.
At the time revenue is recognized, the Company estimates the cost of expected future warranty claims but does not exclude any amounts
from revenue. The Company maintains appropriate accounts to reflect the effects of expected future warranty claims on the Company’s
financial position and periodically adjusts those accounts to reflect its actual warranty claim experience. Historically, warranty claims
have been immaterial, and the Company currently does not provide a provision for this liability.
The
Company typically satisfies its performance obligations for goods at a point in time. In most cases, goods are shipped by common carrier
to customers under “FOB Shipping Point” terms. As such, customers typically obtain control of the goods upon shipment. The
Company’s management exercises judgment in determining when performance obligations for goods have been satisfied. In making such
judgments, management typically relies on shipping information obtained from common carriers to evaluate when the customer has obtained
control of the goods.
The
Company’s contracts with customers typically do not involve variable consideration. The information that the Company uses to determine
the transaction price for a contract is similar to the information that the Company’s management uses in establishing the prices
of goods to be sold.
Leases
Effective
January 1, 2021, the Company adopted Accounting Standards Updated (“ASU”) No. 2016-02, Leases (Topic 842) (“ASU
2016-02” or “ASC 842”), using the full retrospective method, the cumulative effect of the accounting change is recognized
as an adjustment to the opening balance of retained earnings in the first comparative period presented. 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.
16
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.
Impairment
of Long-Lived Assets
Long-lived
assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset group may
not be recoverable. If events or changes in circumstances indicate that the carrying amount of an asset group may not be recoverable,
we compare the carrying amount of the asset group to future undiscounted net cash flows, excluding interest costs, expected to be generated
by the asset group and their ultimate disposition. If the sum of the undiscounted cash flows is less than the carrying value, the impairment
to be recognized is measured by the amount by which the carrying amount of the asset group exceeds the fair value of the asset group.
Assets to be disposed of are reported at the lower of the carrying amount or fair value, less costs to sell.
Concentrations
of Credit Risk
The
Company’s business activity consists of the sale of medical neuromodulation devices to doctors, clinics, and hospitals across the
country.
Receivables
consist of unsecured amounts due from customers. As of June 30, 2023, accounts receivable from two customers with balances due in excess
of 10 % of total accounts receivable were approximately 13 %, and 13 %, respectively. As of December 31, 2022, accounts receivable from three
customers with balances due in excess of 10 % of total accounts receivable was 23 %, 15 %, and 12 %, respectively.
The
table below sets forth the Company’s customers that accounted for greater than 10% of its revenues for the three months ended
June 30, 2023 and 2022, respectively.
Schedule
of Customers Accounted Revenues
2023
Percentage of Sales
2022
Percentage of Sales
Hospital A
$ 95,200
15 %
$ 131,700
19 %
Hospital B
8,900
1 %
120,800
17 %
Hospital C
138,400
21 %
114,730
16 %
$ 242,500
37 %
$ 367,230
52 %
The table below sets forth the Company’s customers that accounted for greater than 10% of its revenues for
the six months ended June 30, 2023 and 2022, respectively.
2023
Percentage of Sales
2022
Percentage of Sales
Hospital A
$
185,550
13
%
$
370,000
25
%
Hospital B
291,420
20
%
243,000
16
%
Hospital C
131,100
9
%
188,205
13
%
$
608,070
42
%
$
801,205
54
%
From
time to time, the Company’s bank balances may exceed the FDIC limit of $ 250,000 ; however, management does not feel that this has
a material impact on the financial condition. At June 30, 2023 and December 31, 2022, the Company’s uninsured cash balances totaled
$ 0 .
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, 2023, we had a stockholders’ deficit of approximately $ 10.0 million. At June 30, 2023, we had short-term
outstanding borrowings of approximately $ 1.5 million, net of discounts of $ 4,421,424 . As of June 30, 2023, we had cash of approximately
$ 51 thousand and a working capital deficit of approximately $ 11.0 million.
17
On
August 11, 2023, the Company consummated its initial public offering (the “IPO”), 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 approximately
$ 6.6 million. Net proceeds to the Company, after deducting underwriting discounts and commissions and offering expenses paid by the Company,
were approximately $ 6.1 million. 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 8, 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. See Note 17 Subsequent Events.
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 2023 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 first quarter 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, 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
June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments, which requires measurement and recognition of expected credit losses for financial assets held and requires enhanced disclosures
regarding significant estimates and judgments used in estimating credit losses. In November 2019, the FASB issued ASU 2019-10, Financial
Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842): Effective Dates, which amends
the effective date of ASU 2016-13. Public business entities meeting the definition of an SEC filer, excluding entities eligible to be
a Smaller Reporting Company (“SRC”) as defined by the SEC, are required to adopt the standard for fiscal years beginning
after December 15, 2019, including interim periods within those fiscal years. All other entities are required to adopt the standard for
fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company meets the definition
of an SRC and therefore the standard was effective at the beginning of 2023. The adoption of this guidance did not have a material impact
on the Company’s financial statements.
18
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 $ 1,128,989 as of June 30, 2023. The current loan balances are as follows:
Schedule
of Related Party Transactions
Loan
Interest
Interest
June 30, 2023
Receivable
Receivable
Income
Shareholder 1
$ 506,400
$ 58,161
$ 11,091
Shareholder 2
506,400
58,027
11,091
1,012,800
116,188
22,182
Allowance for Collection Risk
( 1,012,800 )
( 116,188 )
( 22,182 )
Net Balance
$ —
$ —
$ —
Loan
Interest
Interest
December 31, 2022
Receivable
Receivable
Income
Shareholder 1
$ 506,400
$ 47,071
$ 11,523
Shareholder 2
506,400
46,936
11,523
1,012,800
94,007
23,046
Allowance for Collection Risk
( 1,012,800 )
( 94,007 )
( 23,046 )
Net Balance
$ —
$ —
$ —
The
Company has loans payable to shareholders related to funding needs for operations. The current loan details for all related party loans
are as follows:
Schedule
of Related Party Loans payable to shareholder
Interest &
Interest
Loan
Service Fee
Interest
June 30, 2023
Due Date
Rate
Balance
Accrued
Paid
Shareholder 1
June, 2019
15.00 %
$ 20,051
$ 9,664
$ —
Shareholder 1
June, 2019
15.00 %
38,000
26,331
—
Other Convertibles
Various
5.00 %
—
66,648
—
Total
$ 58,051
$ 102,643
$ —
Interest &
Interest
Loan
Service Fee
Interest
December 31, 2022
Due Date
Rate
Balance
Accrued
Paid
Shareholder 1
June, 2019
15.00 %
$ 20,051
$ 8,161
$ —
Shareholder 1
June, 2019
15.00 %
38,000
23,481
—
Other Convertibles
Various
5.00 %
—
66,648
—
Total
$ 58,051
$ 98,290
$ —
The
Company’s Chief Financial Officer, John Seale, CPA.CITP, is contracted for services through RBSK Partners PC (RBSK). Mr. Seale
is RBSK’s managing partner and majority shareholder. RBSK is engaged by the Company to provide accounting and tax services on a
continuous basis. Fees paid to RBSK for services were $ 64,931 and $ 47,895 for the six months ended June 30, 2023 and 2022, respectively.
The Company owed RBSK for open invoices of $ 196,293 and $ 68,142 that are included in accounts payable as of June 30, 2023 and December
31, 2022, respectively.
19
4.
Property and Equipment
Property
and equipment, net consists of the following:
Schedule
of Property And Equipment
June 30,
December 31,
2023
2022
Furniture and fixtures
$ 87,148
$ 87,148
Computer hardware
27,519
15,452
Leasehold improvements
21,064
21,064
Machinery and equipment
282,181
282,181
Total property and equipment
417,912
405,845
Less: accumulated depreciation
( 332,651 )
( 317,834 )
Property and equipment, net
$ 85,261
$ 88,011
Depreciation
expense was $ 7,589 and $ 7,830
for the three months ended June 30, 2023 and June 30, 2022, respectively, and was $ 14,817 and $ 15,725 for the six months ended June 30, 2023 and June 30, 2022, respectively.
5.
Intangible Assets
Intangible
assets, net consists of the following:
Schedule
of Intangible Assets
June 30,
December 31,
2023
2022
Software Implementation
$ 49,815
$ 49,815
Patents
32,464
32,463
Patents
10,000
10,000
Patents
1,000
—
Total intangible assets
93,279
92,278
Less: accumulated amortization
( 19,963 )
( 14,720 )
Intangible assets, net
$ 73,316
$ 77,558
Amortization
expense was $ 2,621
and $ 485
for the three months ended June 30, 2023 and June 30, 2022, respectively, and was $ 5,243 and $ 970 for the six months ended June 30, 2023 and June 30, 2022, respectively.
6.
Accrued Expenses
Accrued
expenses consisted of the following:
Schedule
of Accrued Expenses
June 30,
2023
December 31,
2022
Wages
$ 561,772
$ 523,003
Employee benefits
26,286
16,555
Commissions
89,199
-
Capital raise fees
( 3,250 )
88,259
Property taxes
866
777
Interest
463,512
173,826
Related party interest
35,996
31,642
Total accrued expenses
$ 1,174,381
$ 834,062
20
7.
Notes Payable
On
February 15, 2023, The Company signed a promissory note with Exchange Listing, LLC in the amount of $ 52,600 . The note carries an interest
rate of 1 %. The interest shall accrue on the outstanding balance until the date of repayment and shall be payable at the time and place
and in the manner provided in this promissory note. The Note shall be paid on the earlier of (i) three months from the date hereof or
the Company receiving a financing in the minimum of $ 3,000,000 .
The
Company borrowed $ 250,000 on December 16, 2021, from Channel Partners Capital. The note calls for 65 weekly payments of $ 4,923.08 with
the final payment scheduled for March 16, 2023 . The note’s interest rate computes to a nominal rate of 40.856 %. The principal outstanding
at December 31, 2021 was $ 244,048 . The Company borrowed $ 122,000 on September 16, 2022 to bring the principal balance back to $ 250,000 .
The principal outstanding at December 31, 2022 was $ 202,834 . 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 at June 30, 2023 was $ 235,586 . 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.
The
future minimum principal payments to be paid in 2023 and 2024 are $ 87,524 and $ 148,062 , respectively.
Convertible
Notes
From
March to June of 2023 the Company conducted multiple closings of a private placement offering to accredited investors for aggregate gross
principal of $ 4,733,333 or net proceeds of $ 3,828,000 .
The
notes consisted of (a) a Convertible Promissory Note that accrues interest at 12 %
that can be paid in cash or PIK. The notes automatically convert into common shares at a 30 %
discount to the IPO. The notes mature on the sooner of the six-month anniversary date from issuance or a successful IPO on primary exchange
in the U.S. (b) a five-year warrant to purchase common stock equal to fifty percent (50%) of the shares into which the 2023 Convertible
Notes can be converted into at issuance. The warrants have a strike price at a 25 %
premium to the Conversion Price subject to anti-dilution, issuable on a pro rata basis at each funding.
As
facilitators to the notes Signature Bank and Alexander Capital, L.P. will receive certain fees. Signature Bank received a $ 6,000
escrow fee from the first round of funding. Alexander Capital, L.P. has and will continue to receive (i) a cash commission of ten
percent (10%) of the proceeds raised in the offering from investors introduced to the Company by the Placement Agent; (ii) the
granting to the Placement Agent of a warrant for the purchase of a number of shares of Common Stock equal to 6% of the number of
Underlying Securities; and (iii) the other matters set forth in the engagement letter between the Company and the Placement Agent
dated April 13, 2022. As of June 30, 2023, Alexander Capital, L.P., has received fees totaling $ 338,250
which is recorded in debt discounts on the balance sheet and will receive 94,370
warrants which are recorded at fair value in warrant liability and debt discounts on the balance sheet.
During
the year ended December 31, 2022, the Company conducted multiple closings of a private placement offering to accredited investors for
aggregate gross amount of $ 3,555,556 and net proceeds of $ 3,070,000 .
The
2022 Convertible Notes signed from June 3, 2022 to November 30, 2022 have aggregate gross amounts of $ 3,333,333 and net proceeds of $ 2,870,000
and consisted of (a) a Convertible Promissory Note that accrues interest at the greater of Prime rate plus 8.5% or 12%. The notes convert
into common shares at the lower of $ 9.44 or 30 % discount to the price per share of any subsequent offering. The notes mature on the one -year
anniversary date from issuance. (b) a five-year warrant to purchase common stock equal to one hundred percent (100%) of the shares into
which the 2022 Convertible Notes can be converted into at issuance. The warrants have an exercise price at the lower of $ 11.80 per share
or a 12.5 % discount to the price per share of any subsequent offering. (c) shares of the Company’s common stock equal to 10% of
the principal amount of these notes, at a value per share equal to the conversion price. The 35,318 shares of common stock issued to
investors had a relative fair value of $ 4,789 .
21
As
an additional incentive for entering into the convertible note offering, the Company offered an original issue discount equal to 10 %
of the principal amount of the notes. The Company also paid $ 130,000
to law firms related to the convertible note offering.
In
March of 2023, the Company used borrowings from the 2023 convertible notes to pay the principal balance of some of the notes totaling,
2.65 million. Upon payment, the terms for the remaining balance of those notes were also updated. The remaining balance accrues interest
at 8 % per annum without maturity or default rights. The new balance shall also automatically convert into shares of common stock at a
27.5 % discount to the per share offering price in the Company’s initial public offering or $ 4.35 per share.
The
2022 Convertible Notes signed on December 19, 2022 have aggregate gross proceeds of $ 200,000
or net proceeds of $ 222,222
and consisted of an original issue discount of 10 %
of the principal amount and have an interest rate of 12 %
per annum. The notes will mature at the earlier of (i) twelve (12) months from the issue date or (ii) the date upon which the
Company completes a registered public offering of shares of the Company, which encompasses the closing of the IPO. The notes are
convertible into shares of common stock at the higher of (i) $ 9.44
per share, or (ii) the price per share of common stock issued pursuant to the next registered public offering of shares of the
Company made prior to the conversion of any portion of the note. Interest accrues on the aggregate principal amount (which includes
original issue discount) and is payable on the maturity date, at the Company’s election, in cash or in-kind. The holders of
the notes are entitled to piggyback registration rights on any registration statement filed by the Company, other than any
registration statement filed on Form S-4 or Form S-8. The warrants and conversion shares are subject to anti-dilution adjustments
outlined in the Agreement.
The
Company has applied ASC 815 and ASC 480, due to the potential for settlement in a variable quantity of shares. Since these convertible
notes and warrants have the option to convert or be exercised at a variable amount, they are subject to derivative liability treatment.
The conversion feature has been measured at fair value using a Monte Carlo model at the date of issuance and is adjusted to fair value
at each reporting period. The fair value of the embedded derivative and the warrant liability at date of issuance was $ 4,316,047 and
$ 4,693,703 , respectively. See Notes 12 and 13.
The
value of the incentives given to investors totaled $ 10,395,941 .
Since the value of the incentives given to certain investors was in excess of the principal value of the notes, the Company
recognized $ 8,070,952
as debt discount and expensed the remaining $ 2,324,988
as financing fees. The debt discount is being accreted over the life of these notes to accretion of debt discount and issuance cost.
As of June 30, 2023, the Company has amortized $ 3,649,528
of the debt discount at effective interest rates ranging from 73.857 %
to 2,149.621 %.
The remaining balance of $ 4,421,424
will be accreted over the remaining life of the notes.
During
the periods ended June 30, 2023 and December 31, 2022, the Company accrued interest to these convertible notes of $ 289,319
and $ 107,544 ,
respectively, included in accrued expenses on the balance sheet.
8.
Leases
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 at June 30, 2023 and December 31, 2022.
The
Company had three leases primarily consisting of office space in Versailles and Carmel Indiana. Two of the leases in Versailles started
January 1, 2017. Both have an initial term of five years with an option for an additional five-year term. The monthly lease payments
for these leases are $ 550 and $ 1,600 with a 3 % per annum increase starting with the optional five-year term. The lease in Carmel started
March 1, 2016. The initial term is five years and three months with an option for an additional three-year term. The monthly lease payment
started at $ 1,472 with an annual increase of approximately 2.7 %. On December 16, 2020, the Company entered into an amendment of the Carmel
lease that extended the initial term by two years .
22
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 periods ended June 30, 2023 and December 31, 2022, the Company recognized $ 23,704 and $ 47,571 of operating lease expense, including
short-term lease expense and variable lease costs, which are immaterial.
The
following table presents information related to the Company’s operating leases:
Schedule
of Operating Leases
June 30, 2023
December 31, 2022
Operating lease right-of-use assets
$ 85,823
$ 101,382
Other current liabilities
41,261
33,395
Operating lease liabilities
51,635
76,199
Total
$ 92,896
$ 109,594
Weighted-average remaining lease term (in years)
3.75
4.00
Weighted-average discount rate
15.0 %
15.0 %
As
of June 30, 2023, the maturities of the Company’s operating lease liabilities were as follows:
Schedule
of Maturities Operating Lease Liabilities
2023
$ 22,268
2024
36,302
2025
28,192
2026
29,038
2027
—
Total lease payments
115,800
Less: imputed interest
22,904
Total present value of lease payments
$ 92,896
9.
Common Stock and Warrants
On
September 7, 2021, the Company’s board of directors authorized a 4-for-1 stock split . They also increased the number of authorized
common stock shares from 2,700,000 to 10,800,000 . Furthermore, on September 9, 2021, the board authorized an increase of authorized shares
of common stock from 10,800,000 to 13,400,000 in anticipation of a capital offering. As part of the conversion to a Delaware Corporation
in June of 2022, the total number of common stock shares authorized was increased to 100,000,000 . All share and per share amounts for
the common stock have been retroactively restated to give effect to the split.
Furthermore,
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.
23
In
connection with a bridge loan, the Company issued a warrant to a shareholder, Brian Hannasch, on September 18, 2018. The warrant
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 to Brian Hannasch on September 6, 2019, under similar terms. This 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 .
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.
During
2022, the Company issued 353,110 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 into at issuance. The warrants have an exercise price of $ 5.25 per share.
From
March to June of 2023, the Company issued 488,828 one-year warrants to purchase common stock equal to fifty percent (50%) of the shares
into which the 2023 convertible notes can be converted into at issuance. The warrants have an exercise price of $ 5.25 per share.
24
The
following is a summary of warrant activity for common stock during the periods ended June 30, 2023 and December 31, 2022:
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 December 31, 2021
52,852
$ 2.13
7.45
Granted
353,110
5.25
4.62
Cancelled/Expired
—
—
—
Exercised
—
—
—
Outstanding as of December 31, 2022
405,962
$ 4.84
4.85
Granted
488,828
$ 5.25
4.80
Cancelled/Expired
—
—
—
Exercised
—
—
—
Outstanding as of June 30, 2023
894,790
$ 5.07
4.62
The
following is a summary of warrant activity for preferred stock during the periods ended June 30, 2023 and December 31, 2022:
Schedule
of Warrant Activity for Preferred Stock
Number of
Weighted-Avg.
Warrants for
Exercise
Preferred Stock
Price
Outstanding as of December 31, 2021
—
$ —
Granted
144,890
0.0001
Cancelled/Expired
—
—
Exercised
—
—
Outstanding as of December 31, 2022
144,890
$ 0.0001
Granted
—
$ —
Cancelled/Expired
—
—
Exercised
—
—
Outstanding as of June 30, 2023
144,890
$ 0.0001
The
following table summarizes the Company’s warrants outstanding and exercisable as of June 30, 2023.
Schedule
of Warrants outstanding and Exercisable
Number of
Warrants
Exercise
Expiration
Outstanding
Price
Date
Brian Hannasch W-01
12,852
$ 8.7600
September 18, 2028
Brian Hannasch W-02
40,000
$ 0.0050
September 6, 2029
Masimo Corporation PSA-01
144,890
$ 0.0001
None
2022 Convertible Notes
353,110
$ 5.2500
Various
2023 Convertible Notes
488,828
$ 5.2500
Various
1,039,680
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 25,000
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.
25
10.
Preferred Stock
The
Company has authorized 1,120,000 shares of preferred stock of which 1,000,000 has been designated Series A Preferred and 120,000 has
been designated Series Seed Preferred, of which 506,637 shares of Series A Preferred and 115,477 shares of Series Seed Preferred are
issued and outstanding as of June 30, 2023 and December 31, 2022.
The
aggregate purchase price of the Series A Preferred Stock was $ 9,321,165 , of which $ 7,692,664 was comprised of cash and the remaining
$ 1,628,501 was comprised of converted debt and common stock. The aggregate purchase price of the Series Seed Preferred shares was $ 0 ,
as all the Series Seed shares were converted from common stock as an incentive to reinvest in Series A Preferred Stock.
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.
In
consideration for shareholders to make an additional investment in the Company, upon the purchase of the Series A Preferred stock by
the shareholder, the Company converted the existing common shares held by shareholders to Series Seed Preferred Stock at a $ 100 million
valuation and at a 120 % share premium. As of June 30, 2023 and December 31, 2022, there were 97,702 common shares converted into 115,477
shares of Series Seed Preferred shares that have no par value and are outstanding.
Preferred
stock has all converted pursuant to the initial public offering. See Note 17 Subsequent Events.
26
11.
Stock Options and Awards
The
following is a summary of stock option activity for the periods ended June 30, 2023 and December 31, 2022:
Schedule
of Stock Option Activity
Weighted Avg.
Remaining
Number of
Contractual Life
Weighted Avg.
Aggregate
Options
(in years)
Exercise Price
Intrinsic Value
Outstanding as of December 31, 2021
1,319,394
7.69
$ 6.94
$ —
Granted
—
Forfeited
—
Cancelled/Expired
—
Exercised
—
Outstanding as of December 31, 2022
1,319,394
6.69
$ 6.94
$ —
Granted
—
Forfeited
—
Cancelled/Expired
—
Exercised
—
Outstanding as of June 30, 2023
1,319,394
6.20
$ 6.94
$ —
Vested and Exercisable as of June 30, 2023
1,319,394
6.20
$ 6.94
$ —
Stock-based
compensation expense is classified in the Company’s statements of operations as general and administrative expense. The amounts
were $ 0 and $ 24,121 for the six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023, there was no unrecognized compensation
expense related to unvested options granted under the Company’s share-based compensation plans.
12.
Warrant Liabilities
The
Company has evaluated financial instruments arising from an adjustable exercise price for warrants that are issued and outstanding as
of June 30, 2023 and December 31, 2022.
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 $ 7.91 per share, an expected remaining term of each warrant
as of the valuation date, estimated volatility of 75 %, drift, and a risk-free rate ranging from 3.46 % to 4.16 % .
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.
27
The
following are the changes in the warrant liabilities during the quarter ended June 30, 2023 and year ended December 31, 2022.
Schedule
of Changes in Warrant Liabilities
Level 1
Level 2
Level 3
Warrant liabilities as of January 1, 2022
$ —
$ —
$ 32,102
Addition
—
—
2,808,331
Changes in fair value of warrant liabilities
—
—
( 606,049 )
Warrant liabilities as of January 1, 2023
—
—
2,234,384
Addition
—
—
1,541,955
Changes in fair value of warrant liabilities
—
—
( 234,807 )
Warrant liabilities as of March 31, 2023
—
—
3,541,532
Addition
—
—
339,302
Changes in fair value of warrant liabilities
—
—
36,050
Warrant liabilities as of June 30, 2023
$ —
$ —
$ 3,916,884
13.
Derivative Liabilities
The
Company has identified derivative instruments arising from the conversion shares discussed in the Convertible Notes section of note 6
as of June 30, 2023 and December 31, 2022.
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 $ 7.91 per share, an expected remaining term of
each warrant as of the valuation date, estimated volatility of 70 %, 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 warrant liabilities during the quarter ended June 30, 2023 and year ended December 31, 2022.
Schedule
of Changes in Derivative Liabilities
Level 1
Level 2
Level 3
Derivative liabilities as of January 1, 2022
$ —
$ —
$ —
Addition
—
—
2,449,689
Changes in fair value of Derivative liabilities
—
—
( 713,989 )
Derivative liabilities as of January 1, 2023
—
—
1,735,700
Addition
—
—
1,532,725
Changes in fair value of Derivative liabilities
—
—
( 191,297 )
Extinguishment of Derivative liabilities
—
—
( 1,129,498 )
Derivative liabilities as of March 31, 2023
-
-
1,947,630
Addition
—
—
328,259
Changes in fair value of Derivative liabilities
—
—
( 860 )
Derivative liabilities as of June 30, 2023
$ —
$ —
$ 2,275,029
28
14.
Retirement Plan
The
Company sponsors a 401(k)-retirement plan for its employees. Employees are eligible to participate in the elective deferral portion of
the plan after twelve months and 1,000 hours of service. The Company matches the employee’s contribution up to 3 %. The Company
can also make an optional profit-sharing contribution to the employee accounts on an annual basis. There was an expense of $ 9,731 and
$ 8,554 for six months ended June 30, 2023 and 2022, respectively.
15 .
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
On
July 11, 2022, the Company entered into an agreement for a trademark related to the Company’s name. An initial payment of $ 10,000
was paid upon execution of the agreement. A second and final payment of $ 40,000 is contingent upon the completion of the Company’s
planned initial public offering. The second payment has not been recorded in these financial statements. See Note 17 Subsequent Events.
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 $ 1.92 million 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 $ 1.11 million. The special incentive payment amount includes
any accrued backpay wages for the employee. That accrued amount for backpay was $ 417,390 and has been recorded and is reflected in the
financial statements at June 30, 2023.
There
are seven key employees that have stock options of the Company totaling 2,477,424 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 $ 14.82
million that are contingent upon a successful
initial public offering have not been record ed.
29
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 has filed a motion to dismiss all claims, but no ruling has been issued. No date had been established
for the court to rule on that motion. While it is too early to predict the ultimate outcome of this matter, we believe we have meritorious
defenses and intend to defend this matter vigorously.
On
July 25, 2023, the court entered a scheduling order that set the deadline to file dispositive motions as March 11, 2024.
30
16.
Health Benefit Plan
The
Company entered into a self-funded program employer agreement in 2018 in conjunction with a group health plan for the benefit of eligible
employees. This plan is a level funded plan, and the services and products include:
●
A
self-funded employer health benefit plan.
●
Stop
loss insurance purchased from a stop loss insurance company.
●
Third
party administrator to provide administrative services with regard to the plan.
The
Company maintains a stop loss contract that reimburses the Company for claims paid under the plan if they exceed a predetermined level.
The Company makes contributions for health care costs and associated expenses that are expected during the plan year. The amount of contributions
is determined annually based on the Company’s maximum liability for expected claims, administrative expenses, and premiums for
the stop loss policy. The Company paid premiums of $ 117,122 and $ 90,752 for the six months ended June 30, 2023 and 2022, respectively.
The
Company is responsible for the monthly premiums, as established, and nothing further. The stop loss policy covers the claims if they
exceed the claims funds. After a certain time, and if there is a surplus in the claims fund, the Company may be entitled to receive a
48.5 % refund from the fund. This amount is recognized by the Company when received.
17.
Subsequent Events
The
Company evaluated subsequent events through the date of issuance. The following changes occurred subsequent to June 30, 2023:
Additional
Borrowing – The Company borrowed additional funds subsequent to June 30, 2023, and up through the date of this report.
On
July 15, 2023 the Company conducted multiple closings of a private placement offering to accredited investors for aggregate gross principal
of $ 1,333,333 or net proceeds of $ 1,080,000 .
The
notes consisted of (a) a Convertible Promissory Note that accrues interest at 12 % that can be paid in cash or PIK. The notes automatically
convert into common shares at a 30 % discount to the IPO. The notes mature on the sooner of the six-month anniversary date from issuance
or a successful IPO on primary exchange in the U.S. (b) a five-year warrant to purchase common stock equal to fifty percent (50%) of
the shares into which the 2023 Convertible Notes can be converted into at issuance. The warrants have a strike price at a 25 % premium
to the Conversion Price subject to anti-dilution, issuable on a pro rata basis at each funding.
As
facilitators to the notes Alexander Capital, L.P. will receive certain fees. Alexander Capital, L.P. has and will continue to receive
(i) a cash commission of ten percent (10%) of the proceeds raised in the offering from investors introduced to the Company by the Placement
Agent; (ii) the granting to the Placement Agent of a warrant for the purchase of a number of shares of Common Stock equal to 6% of the
number of Underlying Securities; and (iii) the other matters set forth in the engagement letter between the Company and the Placement
Agent dated April 13, 2022. At the close of the round, Alexander Capital, L.P., has received $ 458,250 and 120,235 warrants.
Initial
Public Offering - On August 11, 2023, the Company consummated the IPO, 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
approximately $ 6.6 million. Net proceeds to the Company, after deducting underwriting discounts and commissions and offering
expenses paid by the Company, were approximately $ 6.1 million. 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 8, 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 thousand)
at closing, as well as $ 175 thousand
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.
31
Trademark
- 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 was recognized and recorded as of the date of the IPO
subsequent to these financial statements. The trademark does not have a determinate life and therefore the cost is not being amortized.
Convertible
Debt Conversion – Pursuant to the IPO, all the convertible debt including interest from 2022 and 2023 was
either converted into common stock or paid back. $ 6,760,708 of principal and interest was converted into 1,605,841 shares of common stock
at the exercise price of $ 4.20 per share. During August 2023, $ 737,453 of principal and interest was repaid in full. These actions extinguished
the remaining derivative liabilities, warrant liabilities, and debt discount.
Preferred
Stock Conversion – Masimo Corporation, being the requisite holder of our outstanding Series A Preferred Stock and Series Seed
Preferred Stock delivered a consent, dated December 22, 2022, to automatically convert all shares of preferred stock into shares of common
stock upon consummation of the initial public offering. As such, upon closing of the IPO, all Series A Preferred
Stock and Series Seed Preferred Stock was converted into 1,244,228 shares of common stock. The Series A Preferred Stock was converted
before any dividends were declared or paid.
Executive
Employment Agreements – On May 4, 2023, the Company amended the Executive Employment Agreements dated August 9, 2022 to
state that the deferred bonuses and one-time incentive bonuses will be contingent upon the public offering. As such, upon closing of
the IPO, the one-time inventive payments totaling $ 1.1
million became due immediately. The closing of the IPO also triggered the deferred bonus program to exercise stock options granted
in the past. The Company will give each employee a cash reimbursement to exercise their options. The
cash reimbursement will be in an amount equal to (i) the aggregate of the strike price or exercise price of all Stock Options, as
defined hereinafter plus (ii) a tax gross-up payment on the Aggregate Strike Price reasonably calculated by the Company at the
highest marginal rates so that after payment of all ordinary income taxes on such Aggregate Strike Price, there remains an amount
sufficient to pay such ordinary income taxes. The cash reimbursement will be issued 20% equally during the years 2024 –
2028. The employee must exercise the options on or before the annual deferral bonus payment date to receive the bonus. There
are a total of 1,238,712
options pertaining to these agreements with an exercise price of $ 6.94 .
32
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.