Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
NeurAxis,
Inc.
Condensed
Balance Sheets
June 30,
2025
December 31,
2024
(Unaudited)
Assets
Current Assets:
Cash and cash equivalents
$ 5,988,456
$ 3,696,870
Accounts receivable, net of credit losses of $ 5,000 and $ 5,000 as of June 30, 2025 and December 31, 2024, respectively
128,518
244,618
Inventories, net of reserves of $ 17,195 and $ 4,454 as of June 30, 2025 and December 31, 2024, respectively
131,432
44,328
Prepaids and other current assets
370,325
280,367
Total current assets
6,618,731
4,266,183
Property and Equipment, at Cost:
484,815
464,402
Less - accumulated depreciation
( 383,711 )
( 374,420 )
Property and equipment, net
101,104
89,982
Other Assets:
Operating lease right of use asset, net
256,656
284,656
Intangible assets, net
91,345
96,588
Security deposit
20,163
20,163
Total Assets
$ 7,087,999
$ 4,757,572
Liabilities
Current Liabilities:
Accounts payable
$ 464,518
$ 596,946
Accrued expenses
1,652,788
1,577,780
Current portion of operating lease payable
69,165
62,754
Notes payable
121,433
154,152
Customer deposits
31,927
32,527
Warrant liabilities
7,454
9,166
Total current liabilities
2,347,285
2,433,325
Non-Current Liabilities:
Operating lease payable, net of current portion
219,880
256,499
Other non-current liabilities
267,540
—
Total non-current liabilities
487,420
256,499
Total liabilities
2,834,705
2,689,824
Commitments and Contingencies (see note 14)
—
—
Stockholders’ Equity
Convertible Series B Preferred stock, $ 0.01 par value; 5,000,000 shares authorized; 3,896,907 and 4,280,939 shares issued and outstanding as of June 30, 2025 and December 31, 2024
3,897
4,281
Common stock, $ 0.001 par value; 100,000,000 shares authorized; 9,858,716 and 6,990,227 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively
9,859
6,990
Additional paid in capital
65,008,252
58,856,089
Accumulated deficit
( 60,768,714 )
( 56,799,612 )
Total stockholders’ equity
4,253,294
2,067,748
Total Liabilities and Stockholders’ Equity
$ 7,087,999
$ 4,757,572
The
accompanying notes are an integral part of these unaudited condensed financial statements
3
NeurAxis,
Inc.
Condensed
Statements of Operations (Unaudited)
For the Three Months Ended
June 30,
For the Six Months Ended
June 30,
2025
2024
2025
2024
Net Sales
$ 894,086
$ 611,500
$ 1,789,741
$ 1,258,135
Cost of Goods Sold
146,643
73,458
286,118
148,539
Gross Profit
747,443
538,042
1,503,623
1,109,596
Selling Expenses
142,253
62,274
276,206
142,304
Research and Development
58,319
54,312
108,012
59,882
General and Administrative
2,264,729
2,628,288
5,132,360
4,946,362
Operating Loss
( 1,717,858 )
( 2,206,832 )
( 4,012,955 )
( 4,038,952 )
Other Income (Expense):
Financing charges
—
—
—
( 230,824 )
Interest expense
( 13,434 )
( 80,697 )
( 15,672 )
( 107,257 )
Change in fair value of warrant liability
( 119 )
7,576
1,712
( 1,708 )
Amortization of debt discount and issuance cost
—
( 63,817 )
—
( 85,500 )
Other income
40,993
2,961
57,813
2,961
Other expense
—
( 576,901 )
( 577,081 )
Total other income (expense), net
27,440
( 710,878 )
43,853
( 999,409 )
Net Loss
( 1,690,418 )
( 2,917,710 )
( 3,969,102 )
( 5,038,361 )
Preferred stock dividends
( 207,465 )
—
( 421,008 )
—
Net Loss Available to Common Stockholders
$ ( 1,897,883 )
$ ( 2,917,710 )
$ ( 4,390,110 )
$ ( 5,038,361 )
Per-Share Data
Basic and diluted loss per share
$ ( 0.22 )
$ ( 0.42 )
$ ( 0.56 )
$ ( 0.73 )
Weighted Average Shares Outstanding
Basic and diluted
8,520,596
6,921,004
7,903,726
6,902,841
The
accompanying notes are an integral part of these unaudited condensed financial statements
4
NeurAxis,
Inc.
Condensed
Statements of Stockholders’ Equity (Deficit) (Unaudited)
For the Three and Six Months Ended June 30, 2024
Convertible
Series B Preferred Stock
Common
Stock
Additional
Paid In
Accumulated
Stockholders’
Equity
Shares
Amount
Shares
Amount
Capital
Deficit
(Deficit)
Balances
at January 1, 2024
-
$ -
6,508,897
$ 6,509
$ 47,148,361
$ ( 48,558,111 )
$ ( 1,403,241 )
Warrants
exercised
-
-
11,000
11
26,169
-
26,180
Additional
paid in capital from warrants issued under advisory agreement
-
-
-
-
15,543
-
15,543
Additional
paid in capital from warrants issued as debt discount
-
-
-
-
97,465
-
97,465
Common
stock issued from agreements
-
-
75,000
75
200,175
-
200,250
Net
loss
-
-
-
-
-
( 2,120,651 )
( 2,120,651 )
Balances
at March 31, 2024
-
$ -
6,594,897
$ 6,595
$ 47,487,713
$ ( 50,678,762 )
$ ( 3,184,454 )
Additional
paid in capital from warrants issued under consulting agreement
-
-
-
-
44,853
-
44,853
Common
stock issued from agreements
-
-
246,724
247
798,682
-
798,929
Net
loss
-
-
-
-
-
( 2,917,710 )
( 2,917,710 )
Balances
at June 30, 2024
-
$ -
6,841,621
$ 6,842
$ 48,331,248
$ ( 53,596,472 )
$ ( 5,258,382 )
5
NeurAxis, Inc.
Condensed Statements of Stockholders’ Equity (Deficit) (Unaudited)
For the Three and Six Months Ended June 30, 2025
Convertible
Series B Preferred Stock
Common
Stock
Additional
Paid In
Accumulated
Stockholders’
Equity
Shares
Amount
Shares
Amount
Capital
Deficit
(Deficit)
Balances
at January 1, 2025
4,280,939
$ 4,281
6,990,227
$ 6,990
$ 58,856,089
$ ( 56,799,612 )
$ 2,067,748
Warrants
exercised
-
-
186,166
186
( 186 )
-
-
Common
stock issued from agreements
-
-
39,471
40
112,453
-
112,493
Vesting
of restricted stock awards
-
-
-
-
356,922
-
356,922
Net
loss
-
-
-
-
-
( 2,278,684 )
( 2,278,684 )
Balances
at March 31, 2025
4,280,939
$ 4,281
7,215,864
$ 7,216
$ 59,325,278
$ ( 59,078,296 )
$ 258,479
Balances
4,280,939
$ 4,281
7,215,864
$ 7,216
$ 59,325,278
$ ( 59,078,296 )
$ 258,479
Warrants
exercised
-
-
720,359
720
1,002,271
-
1,002,991
Conversion
of Series B Preferred Stock to common stock
( 384,032 )
( 384 )
384,032
384
-
-
-
Issuance
of common stock pursuant to shelf registration statement
-
-
1,538,461
1,539
4,998,460
-
4,999,999
Offering
costs
-
-
-
-
( 490,799 )
-
( 490,799 )
Vesting of restricted stock awards
-
-
-
-
173,042
-
173,042
Net
loss
-
-
-
-
-
( 1,690,418 )
( 1,690,418 )
Balances
at June 30, 2025
3,896,907
$ 3,897
9,858,716
$ 9,859
$ 65,008,252
$ ( 60,768,714 )
$ 4,253,294
Balances
3,896,907
$ 3,897
9,858,716
$ 9,859
$ 65,008,252
$ ( 60,768,714 )
$ 4,253,294
The
accompanying notes are an integral part of these unaudited condensed financial statements
6
NeurAxis,
Inc.
Condensed
Statements of Cash Flows (Unaudited)
For
the Six Months Ended
June 30,
2025
2024
Cash Flows
from Operating Activities
Net
Loss
$ ( 3,969,102 )
$ ( 5,038,361 )
Adjustments
to reconcile net loss to net cash used by operating activities:
Amortization
of debt discount and issuance cost
—
85,500
Provision
for losses on inventory
12,741
—
Depreciation
and amortization
19,241
21,707
Provisions
for losses on accounts receivable
—
20,001
Loss on
disposal of property and equipment
168
—
Non-cash
lease expense
28,001
31,152
Stock-based
compensation
278,854
227,000
Issuance
of common stock for non-cash consideration
—
831,382
Issuance
of warrants for non-cash consideration
—
60,396
Change
in fair value of warrant liabilities
( 1,712 )
1,708
Changes
in operating assets and liabilities:
Accounts
receivable
116,100
( 93,964 )
Inventory
( 99,845 )
( 21,490 )
Prepaids
and other current assets
32,295
13,342
Accounts
payable
( 132,430 )
( 85,902 )
Accrued
expenses
407,812
1,007,508
Customer
deposits
( 600 )
7,175
Operating
lease liability
( 30,208 )
( 14,449 ))
Other
non-current liabilities
267,540
—
Net
cash used in operating activities
( 3,071,145 )
( 2,947,295 )
Cash Flows
from Investing Activities
Additions
to property and equipment
( 25,288 )
( 23,408 )
Net
cash used in investing activities
( 25,288 )
( 23,408 )
Cash Flows
from Financing Activities
Offering
costs paid
( 459,999 )
—
Proceeds
from issuance of common shares
4,999,999
—
Proceeds
from exercised warrants
1,002,991
26,180
Principal
payments on notes payable
( 154,972 )
( 109,263 )
Proceeds
from convertible notes, net of fees
—
4,740,500
Net
cash provided by financing activities
5,388,019
4,657,417
Net
Increase in Cash and Cash Equivalents
2,291,586
1,686,714
Cash
and Cash Equivalents at Beginning of Period
3,696,870
78,560
Cash
and Cash Equivalents at End of Period
$ 5,988,456
$ 1,765,274
Supplemental
Disclosure of Operating Activities
Cash paid
for interest
$ 3,701
$ 27,670
Cash refunded
for income taxes
12,977
—
Supplemental
Schedule of Non-Cash Investing and Financing Activities
Recognition
of right of use asset
$ —
$ 284,339
Common
stock issued upon cashless exercise of warrants
186
—
Common
stock issued upon cashless conversion of Series B Preferred Stock
384
—
Fair value
of warrants from debt discount in convertible notes classified as additional paid in capital
—
97,465
Issuance
of note payable to financing company for software subscription
122,253
—
The
accompanying notes are an integral part of these unaudited condensed financial statements
7
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 in 2012 under the name of Innovative Health Solutions, Inc. The name was changed to NeurAxis, Inc. in 2022 when
the Company filed a Certificate of Conversion and became a Delaware corporation.
The
Company is headquartered in Carmel, Indiana, and specializes in the development, production, and sale of medical neuromodulation devices.
The Company has developed four FDA cleared products: (i) the IB-STIM (DEN180057, 2019), (ii) the Rectal Expulsion Device (“RED”)
(K242304,2024), (iii) the NSS-2 Bridge (DEN170018, 2017) and (iv) the original 510(K) clearance (K140530, 2014).
●
The
IB-STIM is a percutaneous electrical nerve field stimulator (PENFS) device that is indicated in patients 8-21 years of age with functional
abdominal pain associated with irritable bowel syndrome.
●
RED
is indicated to evaluate the neuromuscular function of a patient’s ability to expel its contents from the rectum and as a qualitative
test for rectal hypersensitivity patients who experience desire or urge to defecate at lower volumes of distention. RED is intended
to be used in a clinical setting by trained health care providers in adult populations.
●
The
NSS-2 Bridge is a percutaneous nerve field stimulator (PNFS) device indicated for use in the reduction of the symptoms of opioid
withdrawal and was licensed to Masimo Corporation (“Masimo”). Masimo marketed and sold this product as its Masimo Bridge.
On July 1, 2025, the Company terminated the NSS-2 Bridge license with Masimo in exchange for $ 200,000 of consideration payable in
equal installments on December 31, 2025 and June 30, 2026. The termination agreement allowed the Company to recapture the rights
to the trademark (U.S. Registration No. 7,394,465) and two patent applications (Application No. 18/821,225 and Application No. 29/960,608)
that were licensed to Masimo on April 9, 2020.
●
The
original 510(K) device was an Electroacupuncture Device (“EAD”), now called NeuroStim. The EAD is no longer being manufactured,
sold or distributed but reserved only for research purposes.
The
Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States
of America (“U.S. GAAP”) and follow the requirements of the U.S. Securities and Exchange Commission (“SEC”)
for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by
U.S. GAAP can be condensed or omitted. These interim financial statements have been prepared on the same basis as the Company’s
annual financial statements and, in the opinion of management, reflect all adjustments which are necessary for a fair presentation of
the Company’s financial information. These unaudited interim results are not necessarily indicative of the results to be expected
for the year ending December 31, 2025, or any other interim period or for any other future year. These unaudited financial statements
should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December
31, 2024.
8
2.
Summary of Significant Accounting Policies
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 credit
losses, stock-based compensation, income tax provisions, excess and obsolete inventory reserve, and impairment of property and equipment,
and intellectual property. Actual results could differ from those estimates.
Accounts
Receivable and Allowance for Credit Losses
Trade
accounts receivable is stated at the amount management expects to collect from outstanding balances, net of an allowance for credit losses.
Management evaluates many factors when determining the collectability of specific customer accounts, including, but not limited to, creditworthiness,
past transaction and payment history, current economic industry trends and changes in payment terms. Management used assumptions and
judgment based on the best available facts and circumstances to estimate and record an allowance. The Company estimates credit losses
on accounts receivable by utilizing an aging schedule. The allowance for credit losses was $ 5,000 and
$ 5,000 as
of June 30, 2025 and December 31, 2024, respectively. The Company recorded credit losses of $ 20,324
and $ 33,959
for the three and six months ended June 30, 2024, respectively.
There were no credit losses for the three and six months ended June 30, 2025.
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. The Company recorded expired and other inventory charges of $ 12,174 and
$ 12,174 for
the three and six months ended June 30, 2025, respectively. There were no expired inventory charges recorded for the three and six
months ended June 30, 2024. Inventory reserves totaled $ 17,195 and
$ 4,454 as
of June 30, 2025 and December 31, 2024, respectively.
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 accounts include cash, accounts receivable, accounts payable, prepaids, and other current assets. Management
believes the estimated fair value of these accounts on June 30, 2025 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.
9
The
Company’s Level 3 accounts include warrant liabilities. Inputs to determine fair value are generally unobservable and typically
reflect management’s estimates of assumptions that market participants would use in pricing the asset or liability. The fair values
are therefore determined using model-based techniques, including option pricing models and discounted cash flow models. The valuation
techniques involve management’s estimates and judgment based on unobservable inputs. The fair value estimates may not be indicative
of the amounts that would be realized in a market exchange. Additionally, there may be inherent uncertainties or changes in the underlying
assumptions used, which could significantly affect the current or future fair value estimates. Unobservable inputs used in the models
are significant to the fair values of the assets and liabilities.
There
were no transfers between any of the levels during the periods ended June 30, 2025 and December 31, 2024. In addition to assets and liabilities
that are recorded at fair value on a recurring basis, the Company had no assets that were measured on a nonrecurring basis as of June
30, 2025 and December 31, 2024.
Basic
and Diluted Net Income (Loss) per Share
Basic
earnings or loss per share (“EPS”) is computed by dividing net income (loss), net of preferred stock dividends, by the weighted
average number of common shares outstanding during the period. Diluted EPS is determined using the weighted average number of common
shares outstanding during the period, adjusted for the dilutive effect of common stock equivalents that were outstanding for the periods
presented. In periods when losses are reported, which is the case for the three and six month periods ended June 30, 2025 and 2024, respectively,
presented in these financial statements, the weighted average number of common shares outstanding excludes common stock equivalents because
their inclusion would be anti-dilutive.
The
Company had the following potentially dilutive common stock equivalents:
Schedule of Dilutive Common Stock Equivalents
June
30,
2025
2024
Options
1,319,394
1,319,394
Pre-Funded Warrants for Common
Stock
—
289,779
Restricted Stock Units
852,214
—
Warrants
1,419,524
1,880,307
Series B Preferred Stock
3,896,907
—
Undeclared
Cumulative Series B Preferred Stock Dividends
265,662
—
Totals
7,753,701
3,489,480
The
following table presents the calculation of the basic and diluted net loss per share and the effect of preferred stock dividends:
Schedule of Basic and Diluted Net Loss Per Share
Three
Months Ended
June
30,
Six
Months Ended
June
30,
2025
2024
2025
2024
Numerator:
Net
loss
$ ( 1,690,418 )
$ ( 2,917,710 )
$ ( 3,969,102 )
$ ( 5,038,361 )
Preferred
stock dividends
( 207,465 )
-
( 421,008 )
-
Net loss available to common stockholders
( 1,897,883 )
( 2,917,710 )
( 4,390,110 )
( 5,038,361 )
Denominator:
Weighted
average shares of common stock outstanding - basic and diluted
8,520,596
6,921,004
7,903,726
6,902,841
Basic
and diluted net loss per share
$ ( 0.22 )
$ ( 0.42 )
$ ( 0.56 )
$ ( 0.73 )
Stock-Based
Compensation
The
Company accounts for all stock-based awards at fair value. 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 actual forfeiture.
The
Company accounts for the granting of stock options and restricted stock units 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 and restricted stock
units 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. Upon vesting of restricted stock units, the par value of the shares
issued are reclassified from additional paid-in-capital to common stock.
Stock-based
awards 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.
10
Revenue
Recognition
In
accordance with FASB’s ASC 606, Revenue from Contracts with Customers, (“ASC 606”), the Company recognizes revenue
when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects
to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines
are within the scope of ASC 606, it performs the following five steps:
(i)
identify
the contract(s) with a customer;
(ii)
identify
the performance obligations in the contract;
(iii)
determine
the transaction price;
(iv)
allocate
the transaction price to the performance obligations in the contract; and
(v)
recognize
revenue when (or as) the entity satisfies a performance obligation.
The
Company applies the five-step model to contracts when it determines that it is probable it will collect substantially all the consideration
it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined
to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that
are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the
amount of the transaction price, after consideration of variability and constraints, if any, that is allocated to the respective performance
obligation when the performance obligation is satisfied.
The
Company 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.
Certain
economic factors affect the nature, amount, timing, and uncertainty of the Company’s revenue and cash flows. All of the
Company’s products are sold to healthcare customers including hospitals, clinics and physician offices. Sales to healthcare
customers generally lack seasonality and have a mild correlation with economic cycles. All of the Company’s sales are to
customers located within the United States. Sales contracts consist of purchase orders that are short-term (i.e., less than or equal
to one year).
The
Company typically satisfies its performance obligations for goods at a point in time as they are received at the customer’s destination
(rather than over time). Goods are shipped by common carrier to customers under FOB destination terms. As such, ownership of goods in
transit is transferred to the customer upon receipt as the Company bears the associated risks (e.g., loss, damage, delay). Management
typically relies on shipping information from common carriers to evaluate when the customer has obtained control of the goods. Shipping
and handling costs are recorded as Cost of Goods Sold in the Statements of Operations.
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.
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. The estimated returns reserve totaled $ 5,000
and $ 5,000
as of June 30, 2025 and December 31, 2024, respectively.
Payment
for goods sold by the Company is typically due after an invoice is sent to the customer, within 30 days. 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.
Medical
devices that the Company contracts to sell and transfer to customers are manufactured by two third-party manufacturers located in Indiana
and Michigan. 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).
Going
Concern
As
of June 30, 2025, we had stockholders’ equity of $ 4,253,294 and short-term outstanding borrowings of $ 121,433 . Additionally, we
had cash of $ 5,988,456 and a working capital surplus of $ 4,271,446 as of June 30, 2025. However, we have incurred losses and negative
cash flows from operations since inception and have funded our operations primarily with a combination of sales, debt, and the sale of
capital stock.
Our
future capital requirements will depend upon many factors, including progress with developing, manufacturing, and marketing our technologies,
the time and costs involved in preparing, filing, prosecuting, maintaining, and enforcing patent claims and other proprietary rights,
our ability to establish collaborative arrangements, marketing activities and competing technological and market developments, including
regulatory changes and overall economic conditions in our target markets. Our ability to generate revenue and achieve profitability requires
us to successfully market and secure purchase orders for our products from customers currently identified in our sales pipeline and to
new customers as well. The primary activity that will drive all customers and revenues is the adoption of insurance coverage by commercial
insurance carriers nationally, which is a top priority of the Company. These activities, including our planned research and development
efforts, will require significant uses of working capital through the rest of 2025 and beyond.
11
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.
While
the Company believes in the viability of its strategy to further implement its business plan and generate sufficient revenues and in
its ability to raise additional funds by way of a public or private offering of its debt or equity securities, there can be no assurance
that it will be able to do so on reasonable terms, or at all. The ability of the Company to continue as a going concern is dependent
upon its ability to further implement its business plan and generate sufficient revenues and its ability to raise additional funds by
way of a public or private offering. Neither future cash generated from operating activities, nor management’s contingency plans
to mitigate the risk and extend cash resources through the evaluation period, are considered probable. As a result, substantial doubt
is deemed to exist about the Company’s ability to continue as a going concern. As we continue to incur losses, our transition to
profitability is dependent upon achieving a level of revenues adequate to support its cost structure. We may never achieve profitability,
and unless and until doing so, we intend to fund future operations through additional dilutive or nondilutive financing. There can be
no assurances, however, that additional funding will be available on terms acceptable to us, if at all.
The
financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the
amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
Recently
Issued Accounting Pronouncements
In
November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures
(Subtopic (220-40): Disaggregation of Income Statement Expenses, which requires disclosures that disaggregate, in a tabular presentation,
each relevant expense caption on the face of the income statement that includes inventory purchases, employee compensation, depreciation
and intangible amortization expense. Additional disclosures are also required to provide a qualitative description of the amounts in
an expense caption that are not separately disaggregated quantitatively and the total amount of selling expenses including a definition.
Public business entities are required to adopt the standard for fiscal years beginning after December 15, 2026 and interim periods within
fiscal years beginning after December 15, 2027. Disclosures are required for all prior periods presented in the financial statements.
Although the standard requires enhanced disclosures, the adoption is not expected to have a material impact on the Company’s financial
statements.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires the
enhancement of income tax disclosures to provide better insight into how an entity’s operations and related tax risks, planning
and opportunities affect its tax rate and prospects for future cash flows. The enhanced disclosures require (i) specific categories in
a tabular rate reconciliation including both amounts and percentages and (ii) additional information for reconciling items and income
tax paid that meet a quantitative threshold. Public business entities are required to adopt the standard for annual periods beginning
after December 15, 2024. All other entities are required to adopt the standard for annual periods beginning after December 15, 2025.
The adoption of the standard is not expected to have a material impact on the Company’s financial statements.
3.
Related Party Transactions
The
Company has two demand notes receivable from shareholders related to the sale of common stock on January 1, 2016. Both notes’ principal
balances are $ 506,400 , with interest calculated monthly based on applicable federal rates. No payments have been received on the notes.
Since repayment is not assured, the Company provided an allowance for the entire balance of principal and interest as of December 31,
2019. The current allowance is $ 1,012,800 as of June 30, 2025. The current loan balances are as follows:
Schedule of Related Party Transactions
June
30, 2025
December 31, 2024
Loan
Interest
Interest
Loan
Interest
Interest
Receivable
Receivable
Income
Receivable
Receivable
Income
Shareholder 1
$ 506,400
$ 104,694
$ 10,343
$
506,400
$
94,351
$
23,413
Shareholder 2
506,400
104,559
10,343
506,400
94,216
23,413
Principal balance
1,012,800
209,253
20,686
1,012,800
188,567
46,826
Allowance
for collection risk
( 1,012,800 )
( 209,253 )
( 20,686 )
( 1,012,800
)
( 188,567
)
( 46,826
)
Net
balance
$ —
$ —
$ —
$
—
$
—
$
—
The
Company was granted an exclusive, worldwide non-transferable, royalty-free license for the auricular portion of certain patents
owned by a limited liability company in which the Company’s President and Chief Executive Officer and Chief Regulatory,
Compliance and Privacy Officer both maintain an ownership interest. The license allows for the development, marketing and sales of
electro-therapy treatments by stimulation of cranial nerves, cranial nerve branches, auricular nerves, auricular nerve branches,
auricular nerve bundles and auricular anatomical structures in human patient. The exclusive license agreement expires on October 18,
2037, may be terminated by either party upon 60 days prior written notice and requires the Company to pay costs associated with the
maintenance, prosecution and continuation of patent filings. The Company’s Board of Directors pre-approved the reimbursement
of up to $ 10,000
for the year ending December 31, 2025. No
license costs were incurred for the three months ended June 30, 2025 and 2024, respectively. The license costs totaled $ 1,317
and $ 0 for the six months
ended June 30, 2025 and 2024, respectively. No
amounts were owed to the limited liability company as of June 30, 2025 and December 31, 2024, respectively.
From
time to time, a member of the Company’s Board of Directors purchases IB-STIM devices from the Company at cost to conduct
research and development activities. The Company’s Board of Directors pre-approved the sale of these IB-STIM devices up to
$ 16,000
for the year ended December 31, 2025. The Company sold IB-STIM devices for a total of $ 4,394
and $ 978
for the three months ended June 30, 2025 and 2024, respectively, and $ 6,351
and $ 978
for the six months ended June 30, 2025 and 2024, respectively.
The
Company’s former Chief Financial Officer is contracted for services through a third-party public accounting firm. He was the
firm’s managing partner and majority shareholder. The firm is engaged by the Company to provide accounting and tax services on
a continuous basis. The services totaled $ 9,808
and $ 43,560
for the three months ended June 30, 2025 and 2024, respectively, and $ 31,679
and $ 91,168
for the six months ended June 30, 2025 and 2024, respectively. The Company owed the firm $ 2,596
and $ 4,173
as of June 30, 2025 and December 31, 2024, respectively, that is included in accounts payable in the Condensed Balance Sheets. On
June 28, 2024, the Company also issued 20,000
common shares with a fair value $ 55,600
to the former Chief Financial Officer for services rendered during the IPO process.
4.
Prepaids and Other Current Assets
Prepaids
and other current assets consisted of the following:
Schedule
of Prepaids and Other Current Assets
June
30, 2025
December
31, 2024
Prepaid insurance
$ 44,985
$ 186,028
Prepaid software subscriptions
176,940
39,834
Other
148,400
54,505
Total
prepaids and other current assets
$ 370,325
$ 280,367
12
5.
Accrued Expenses
Accrued
expenses consisted of the following:
Schedule of Accrued Expenses
June
30, 2025
December
31, 2024
Compensation and
benefits
$ 1,040,099
$ 1,261,317
Settled litigation
375,000
-
Legal fees
107,045
43,891
Interest
66,648
66,648
Advisory fees
-
176,750
Other
63,996
29,174
Total
accrued expenses
$ 1,652,788
$ 1,577,780
6.
Notes Payable
Promissory
Notes
On
August 9, 2024, the Company entered into a $ 210,000 promissory note to finance the premiums of a business insurance policy, bearing interest
at a rate of 7.40 % per annum that matured on June 9, 2025 . On November 1, 2024, the Company entered into a second promissory note with
a principal balance of $ 64,328 to finance premiums of other business insurance policies, bearing interest at a rate of 7.65 % per annum
and maturing on September 1, 2025 . On May 26, 2025, the Company entered into a third promissory note with a principal balance of $ 122,253
to finance subscription fees on certain software arrangements maturing on March 1, 2027 . The outstanding principal was $ 121,433 and $ 154,152
as of June 30, 2025 and December 31, 2024, respectively.
2024
Convertible Notes
On
November 8, 2023, the Company entered into a Securities Purchase Agreement (“SPA”) with a shareholder for the issuance 1,260,504
shares of Series B Convertible Preferred Stock, par value $ 0.001 per share (the “Series B Preferred Stock”), for an aggregate
purchase price of $ 3,000,000 paid in 15 monthly installments of $ 200,000 each, commencing on the later of January 10, 2024 or a date
after stockholder approval of an amendment to the Company’s Certificate of Incorporation to authorize the creation of the Series
B Preferred Stock. The Series B Preferred Stock was convertible at any time into shares of common stock of the Company without any further
consideration. Following the issuance of the Series B Preferred Stock, it would rank senior to the common stock with respect to payments
upon the liquidation, dissolution and winding up of the Company. Due to a delay in the stockholder approval, the Company amended the
SPA on February 12, 2024 to issue a convertible promissory note, due and payable on the earlier of 15 months or 12 months if the Series
B Preferred Stock has not been authorized, convertible into Series B Convertible Preferred Stock with identical funding amounts and terms
(the “$ 3,000,000 Convertible Promissory Note”). The shareholder funded $ 800,000 of the $ 3,000,000 commitment in 2024.
The
Company then proceeded to enter into a series of incremental convertible promissory notes with other investors totaling $ 1,135,000 with
terms identical to the $ 3,000,000 Convertible Promissory Note (collectively referred to as the “Original 2024 Convertible Promissory
Notes”) for an aggregate principal amount of $ 1,935,000 .
The
2024 Original Convertible Promissory Notes earned interest at 8.5 % per annum payable quarterly in either cash or common stock at the
election of the Company. At any time following the date of shareholder approval to authorize the creation of Series B Preferred Stock
prior to the maturity date, the investor may elect to convert all or part of the principal into the Company’s Series B Preferred
Stock at a conversion price per share equal to $ 2.38 . Without limiting the foregoing, all principal amounts outstanding on the maturity
date will automatically convert into the Company’s Series B Preferred Stock. The Series B Preferred Stock is entitled to cumulative
dividends at 8.5 % per annum (whether or not declared) payable quarterly in either cash or common stock at the $ 2.38 conversion price
at the election of the Company. Upon conversion to Series B Preferred Stock, the investor may elect, at its option at any time, to convert
all or part of the Series B Preferred Stock plus accrued but unpaid dividends into an equivalent amount of common stock at the $ 2.38
conversion price.
13
Subsequently,
the Company entered into three convertible promissory notes with related institutional accredited investors with terms similar to the
Original 2024 Convertible Promissory Notes (collectively referred to as the “Amended 2024 Convertible Promissory Notes”)
for an additional principal amount of $ 3,000,000 . Certain provisions to the SPA and Certificate of Designation previously issued on February
12, 2024 changed, including (i) the number of shares of preferred stock to be designated as Series B Preferred Stock was increased to
4,000,000 shares, (ii) the stated value of the Series B Preferred Stock was changed to $ 2.38 per share, (iii) the right to receive dividends
will expire automatically on June 30, 2025, (iv) the liquidation rights will automatically expire on June 30, 2025, and (v) the number
of shares of the common stock that a holder of Series B Preferred Stock is entitled to receive shall not exceed the maximum percentage
chosen by the holder, which is initially set at between 4.99 % and 19.99 % until shareholder approval is obtained, of the number of outstanding
shares of the common stock at the time of the conversion of the Series B Preferred Stock shares.
The
maturity date was on the earlier of (i) June 21, 2025, (ii) upon written demand occurring on or after March 21, 2025 in the event that
the Series B Preferred Stock has not been duly authorized on or before such date, or (iii) immediately upon the occurrence of an event
of default. Automatic conversion into shares of Series B Preferred Stock (at a conversion price of $ 2.38 per share) would occur following
the date of shareholder approval. In the event the Company failed to obtain shareholder approval before August 15, 2024, rights existed
to convert the outstanding amount into shares of the common stock, at a price per share of $ 2.38 .
As
of August 15, 2024, the Company received $ 4,935,000 of the principal amount of the Amended 2024 Convertible Notes with the remainder
due in monthly installments through March of 2025 resulting in an effective interest rate of 12.5 %. On August 15, 2024, the Company’s
shareholders authorized 5,000,000 shares of preferred stock of which 4,000,000 shares were designated as $ 0.001 par value Series B preferred
stock. Pursuant to the terms of the Amended 2024 Convertible Promissory Notes, the outstanding principal balance of $ 4,935,000 was mandatorily
converted into 2,073,524 Series B Preferred Shares at a conversion price of $ 2.38 on August 15, 2024. Amortization of the debt discount
on the Amended 2024 Convertible Notes totaled $ 63,817 and $ 85,500 for the three and six months ended June 30, 2024. There was no amortization
of the debt discount for the three and six months ended June 30, 2025 as the unamortized debt discount of $ 165,577 was reclassified to
Additional Paid-In-Capital in the Statements of Stockholders’ Equity (Deficit) on August 15, 2024 upon mandatory conversion.
Interest
expense totaled $ 13,434 and $ 80,697 for the three months ended June 30, 2025 and 2024, respectively, and $ 15,672 and $ 107,257 for the
six months ended June 30, 2025 and 2024, respectively. The Company’s accrued interest totaled $ 66,648 as of June 30, 2025 and December
31, 2024.
7.
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 as of June 30, 2025 and December 31, 2024.
The
Company has two leases primarily consisting of office space in Versailles and Carmel, Indiana. The
lease in Versailles started January 1, 2022 and had a term of one year, with automatic one year renewal, unless 60 day notice of
vacating is given, commencing on the execution hereof and continuing through December 31st of each year. The current monthly lease
payment for this lease is $ 1,800
with a 4 %
per annum increase. A new lease in Carmel, Indiana commenced January 1, 2024. The initial term is five years and five months. The
monthly lease payment started at $ 6,721
with an annual increase of 2.5 %.
The Company was only obligated to pay an amount equal to 50% of the monthly base rent for the first 10 months of the
term.
The
Company recognized operating lease expense of $ 25,558 and $ 20,667 for the three months ended June 30, 2025 and 2024, respectively, and
$ 51,082 and $ 46,423 for the six months ended June 30, 2025 and 2024, respectively, including short-term lease expense and variable lease
costs.
On
May 19, 2025, the Company terminated its lease in Versailles, Indiana, effective July 31, 2025, without penalty due to relocation of
the office space to Batesville, Indiana, with the same landlord effective August 1, 2025.
14
The
following table presents information related to the Company’s operating leases:
Schedule of Operating Leases
June
30, 2025
December
31, 2024
Operating
lease right-of-use assets
$ 256,656
$ 284,656
Other current liabilities
69,165
62,754
Operating
lease liabilities
219,880
256,499
Total
$ 289,045
$ 319,253
Weighted-average remaining
lease term (in years)
3.66
2.75
Weighted-average discount
rate
15.0 %
15.0 %
As
of June 30, 2025, the maturities of the Company’s operating lease liabilities were as follows:
Schedule of Maturities Operating Lease Liabilities
2026
$ 106,618
2027
97,481
2028
87,942
2029
82,539
Total lease payments
374,580
Less:
imputed interest
( 85,535 )
Total
present value of lease payments
$ 289,045
8.
Common Stock and Warrants
The
Company authorized 100,000,000 shares of common stock, of which 9,858,716 and 6,990,227 shares were issued and outstanding as of June
30, 2025 and December 31, 2024, respectively.
On
June 30, 2025, the Company issued 289,779 shares of common stock to an investor upon the exercise of an equivalent amount of common stock
warrants for gross proceeds of $ 29 .
On
June 9, 2025, the Company issued 42,016 shares of common stock to an investor upon conversion of an equivalent amount of Series B Preferred
Stock.
On
May 22, 2025, the Company issued 1,538,461 shares of common stock for gross proceeds totaling $ 4,999,999 pursuant to a securities purchase
agreement with certain institutional investors at a purchase price of $ 3.25 per share of common stock. The common shares were offered
by the Company pursuant to its shelf registration statement on Form S-3 (File No. 333-283798) which was declared effective by the Securities
and Exchange Commission on February 11, 2025, a base prospectus dated February 11, 2025 and a prospectus supplement dated May 20, 2025.
The placement agent fees and other offering expenses totaled $ 490,799 for the three and six months ended June 30, 2025.
On
May 21, 2025, the Company issued 430,580 shares of common stock to certain investors upon the exercise of an equivalent amount of common
stock warrants for gross proceeds of $ 1,002,962 .
On
May 20, 2025, the Company issued 342,016 shares of common stock to certain investors upon conversion of an equivalent amount of Series
B Preferred Stock.
On
January 17, 2025, the Company issued (i) 39,471 shares of common stock with a fair value of $ 112,493 to its Board of Directors for their
service from April 1, 2024 through December 31, 2024, which was recorded as general and administrative expense in the Condensed Statements
of Operations and (ii) 186,166 shares of common stock to an investor in exchange for 502,647 warrants in a cashless exercise transaction
with $ 186 reclassified from additional paid in capital to common stock in the Condensed Statements of Stockholders’ Equity (Deficit).
During
the three months ended June 30, 2024, the Company issued (i) 53,063 shares of common stock to an existing shareholder to settle a convertible
note dispute with a fair value of $ 230,823 , (ii) 90,032 shares of common stock to pre-IPO Series A Preferred Stock shareholders to settle
certain claims with a fair value of $ 286,458 , (iii) 33,454 shares of common stock to holders of the Amended 2024 Convertible Promissory
Notes in lieu of $ 79,588 in cash payments for interest through June 30, 2024, (iv) 24,343 shares of common stock to its Board of Directors
for their service from the Company’s IPO on August 9, 2023 through March 31, 2024 with a fair value of $ 67,672 , (v) 25,832 shares
of common stock to its previous Chief Financial Officer in accordance with a severance agreement at a fair value of $ 78,788 and (vi)
20,000 shares of common stock to it previous Chief Financial Officer for services provided during the IPO with a fair value of $ 55,600 .
During
the three months ended March 31, 2024, the Company issued (i) 11,000 shares of common stock upon the exercise of warrants for $ 26,180 ,
(ii) 75,000 shares of common stock as payment to a vendor for services with a fair value of $ 200,250 pursuant to a consulting agreement
related to the Company’s transition to a public company.
15
The
following is a summary of warrant activity for common stock during the six months ended June 30, 2025 and year ended December 31, 2024:
Schedule of Warrant Activity for Common Stock
Number
of
Weighted-Avg.
Weighted-Avg.
Warrants
for
Exercise
Remaining
Common
Stock
Price
Contractual
Life
Outstanding as
of January 1, 2024
1,822,358
$ 4.69
3.05
Granted
861,424
2.38
3.49
Canceled
( 30,252 )
2.38
4.79
Exercised
( 11,000 )
2.38
3.61
Outstanding
as of December 31, 2024
2,642,530
2.41
2.93
Exercised
( 1,223,006 )
1.80
2.10
Outstanding
as of June 30, 2025
1,419,524
$ 2.44
2.77
The
following table summarizes the Company’s warrants outstanding and exercisable as of June 30, 2025:
Schedule of Warrants outstanding and Exercisable
Number
of
Warrants
Exercise
Expiration
Outstanding
Price
Date
Investor Warrant
12,852
$ 8.76
September 18,
2028
2022 Convertible Notes
227,098
$ 2.38
Various in 2027
2023 Convertible Notes
971,916
$ 2.38
Various in 2028
Underwriter Warrants
131,146
$ 2.38
August 8, 2028
Advisory
Agreement Warrants
76,512
$ 2.38
Various
in 2029
1,419,524
16
9.
Preferred Stock
On
August 15, 2024, the Company’s shareholders authorized 5,000,000
shares of preferred stock of which 4,000,000
shares were designated as $ 0.001
par value Series B Preferred Stock with 3,896,907
shares issued and outstanding as of June 30, 2025. Series B Preferred Stock shareholders vote with Common Stock shareholders on an
as-converted basis and not as a separate class. Cumulative dividends accrue at 8.5 %
per annum and are due and payable in either cash for common shares as the Company’s discretion on a quarterly basis through
June 30, 2025. Series B Preferred Stock converts to common stock on a 1:1 basis, subject to adjustments for stock dividends, splits,
combinations and similar events as well as unpaid dividends thereon, solely at the election of the holder at any time.
Prior
to August 15, 2024 the Company had 1,000,000 and 120,000 shares authorized as Series A and Series Seed Preferred Stock, respectively,
of which zero shares are issued and outstanding for both classes of preferred stock as of December 31, 2023, respectively. The Series
A and Series Seed Preferred Stock (i) voted together with common stock on an as-converted basis, and not as separate classes and (ii)
converted 1:1 to common stock at any time at option of holder, subject to adjustments for stock dividends, splits, combinations, and
similar events. The Series A Preferred Stock carried an annual 8 % cumulative dividend, payable upon any liquidation, dissolution or winding
up of the Company. For any other dividends or distributions, the Series A Preferred Stock participated with common stock on an as-converted
basis. The Company’s 1,000,000 shares of Series A Preferred Stock and 120,000 shares of Series Seed Preferred Stock were retired
on August 15, 2024.
Pursuant
to the terms of the Amended 2024 Convertible Notes, the principal balance of $ 4,935,000 on August 15, 2024 was mandatorily converted
into 2,073,524 Series B Preferred Shares at a conversion price of $ 2.38 . Subsequently, the Company then proceeded to issue 64,913 shares
of Series B Preferred Stock to various investors for $ 154,500 .
On
November 11, 2024, the Company’s shareholders authorized (i) an increase in the number of designated Series B Preferred Stock to
5,000,000 shares and (ii) an extension of the 8.5 % per annum cumulative dividend period to December 31, 2026. Subsequently, the Company
issued 2,100,840 shares of Series B Preferred Stock to a dedicated life sciences fund for $ 5,000,000 and 41,662 shares of Series B Preferred
Stock to various investors for $ 99,164 .
On
May 20, 2025, the Company issued 342,016 shares of common stock to certain investors upon conversion of an equivalent amount of Series
B Preferred Stock.
On
June 9, 2025, the Company issued 42,016 shares of common stock to an investor upon conversion of an equivalent amount of Series B Preferred
Stock.
Upon
any liquidation, dissolution or winding up of the Company, whether voluntary or involuntary, the Series B Preferred Stock shareholders
maintain priority preference over all other classes of capital stock. 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, thereby triggering payment of the liquidation preferences.
As
of June 30, 2025 and December 31, 2024, preferred stock dividends were neither declared nor paid. Series B Preferred Stock
undeclared cumulative dividends totaled $ 207,465 , or
$ 0.02 per share, and $ 421,008 , or $ 0.05 per share, for the three and six months ended June 30, 2025,
respectively. Series B Preferred Stock did not exist before August 15, 2024.
17
10.
Stock-Based Compensation
Restricted
Stock Units
Pursuant
to the NeurAxis, Inc. 2022 Omnibus Securities and Incentive Plan, the Company initiated grants of restricted stock units (“RSUs”)
on January 3, 2025, March 4, 2025 and May 15, 2025 to certain employees as follows:
Schedule
of Restricted Stock Units
Number
of
RSUs
Weighted
Average Fair Value
Outstanding as of December 31, 2024
—
$ —
Granted
852,214
2.32
Outstanding
as of June 30, 2025
852,214
$ 2.32
Vested
as of June 30, 2025
12,868
$ 2.31
The
RSUs are subject to a three-year cliff-vesting period and are payable in shares of the Company’s common stock. The RSUs fully vest
upon (i) death or disability or (ii) change of control. Dividend equivalents accrue on RSUs and are paid upon vesting; there were no
accrued dividends on unvested RSUs as of June 30, 2025. No RSUs were granted during the year ended December 31, 2024.
Total
stock-based compensation expense related to RSUs is classified in the Company’s Condensed Statements of Operations as general and
administrative expense and amounted to $ 173,043 and $ 0 for the three months ended June 30, 2025 and 2024, respectively, and $ 278,854
and $ 227,000 for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, total unrecognized stock-compensation
expense relating to unvested stock awards granted under the Company’s share-based compensation plans amounted to $ 1,443,287 .
Stock
Options
The
following is a summary of the Company’s outstanding stock options as of June 30, 2025 and December 31, 2024:
Schedule of Stock Option Activity
Number
of Options
Weighted
Avg.
Remaining Contractual Life (in years)
Weighted
Avg.
Exercise Price
Aggregate
Intrinsic
Value
Outstanding
as of December 31, 2024
1,319,394
4.69
$ 6.94
$ —
Outstanding
as of June 30, 2025
1,319,394
4.19
$ 6.94
$ —
Vested
and Exercisable as of June 30, 2025
1,319,394
4.19
$ 6.94
$ —
There
was no stock-based compensation expense related to stock options recorded for the three and six months ended June 30, 2025 and 2024.
18
11.
Warrant Liabilities
The
Company has evaluated financial instruments arising from warrants that are issued and outstanding as of June 30, 2025 and December 31,
2024. The Company utilizes a Black-Scholes option-pricing model to compute the fair value of the liability and to mark-to-market the
fair value of the warrant at each balance sheet date. The inputs utilized in the application of the Black-Scholes option-pricing model
included (i) an exercise price of $ 8.76 per share, (ii) an expected remaining term of each warrant based on the remaining contractual
maturity of the each warrant, (iii) estimated volatility ranging from 75.0 % to 89.9 % based on historical stock prices of comparable companies
with a look back period commensurate with the period to maturity, (iv) a risk-free interest rate ranging from 3.80 % to 4.38 % based on
the interest rates of U.S. Treasury Notes consistent with the expected remaining contract term and (v) a 0 % expected dividend yield as
the Company has not paid dividends to date and does not anticipate declaring dividends in the near future.
The
following are the changes in the warrant liabilities during the three and six months ended June 30, 2025 and the year ended December
31, 2024:
Schedule of Changes in Warrant Liabilities
Level
3
Warrant liabilities
as of January 1, 2024
$ 8,225
Changes
in fair value of warrant liabilities
941
Warrant liabilities as of
December 31, 2024
9,166
Changes
in fair value of warrant liabilities
( 1,712 )
Warrant liabilities as of
June 30, 2025
$ 7,454
12.
Segment Information
The
Company evaluates the following factors to identify its reportable segments: (i) nature of products and services, (ii) type of
customer for the products and services, (iii) sales, production and distribution methods of the products and services and (iv) the
nature of the regulatory environment, if applicable. Based on an evaluation of these factors, management concluded that the
Company’s operations are managed through one reportable segment, IB-STIM, that derives its revenues in the United States from
a PENFS device that is used to treat patients 8-21 years of age with functional abdominal pain associated with irritable bowel
syndrome. The accounting policies of the IB-STIM segment are the same as those described in the Summary of Significant Accounting
Policies (see Footnote 2). The CODM regularly evaluates the performance of the IB-STIM segment for the purpose of allocating
resources based on net sales and operating loss, both of which are reported in the Condensed Statements of Operations. The CODM uses
net sales to evaluate IB-STIM’s adoption and utilization by insurance carriers and physicians. As NeurAxis is an emerging
growth company, operating loss is used to monitor the Company’s cost structure in order to achieve future segment
profitability. Both net sales and operating loss are measured against the budget on a periodic basis to assess achievement toward
annual compensation incentive targets. The Company’s CODM is its Chief Executive Officer.
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The
following reconciles the reportable segment net sales and operating loss to the Company’s reported net loss:
Schedule
of Reconciles the Company’s Net Sales and Operating Loss
2025
2024
2025
2024
Three
months ended June 30,
Six
months ended June 30,
2025
2024
2025
2024
Net
Revenue
$ 894,086
$ 611,500
$ 1,789,741
$ 1,258,135
COGS
146,643
73,458
286,118
148,539
Gross Profit
747,443
538,042
1,503,623
1,109,596
Selling Expenses
(a)
142,253
62,274
276,206
142,304
Research
& Development (a)
58,319
54,312
108,012
59,882
Compensation
and Benefits (a)
1,478,100
1,533,944
2,822,297
2,832,275
Professional
Services (a)
283,730
664,508
701,308
1,192,444
Other
Operating Expenses (a) (b)
502,899
429,836
1,608,755
921,643
Segment Operating
Loss
( 1,717,858 )
( 2,206,832 )
( 4,012,955 )
( 4,038,952 )
Financing
Charges
-
-
-
( 230,824 )
Interest
Expense
( 13,434 )
( 80,697 )
( 15,672 )
( 107,257 )
Change in
Fair Value of Warrant Liability
( 119 )
7,576
1,712
( 1,708 )
Amortization
of Debt Discount and Issuance Cost
-
( 63,817 )
-
( 85,500 )
Other Income
40,993
2,961
57,813
2,961
Other
Expense
-
( 576,901 )
( 577,081 )
Total
Other (Expense) Income, Net
27,440
( 710,878 )
43,853
( 999,409 )
Net
Loss
$ ( 1,690,418 )
$ ( 2,917,710 )
$ ( 3,969,102 )
$ ( 5,038,361 )
(a)
The significant expense
categories and amounts align with the segment-level information provided on a regular basis to the CODM.
(b)
Other operating expenses
include advertising, rent and utilities, insurance, depreciation and amortization, travel, software subscription fees, board fees
and bad debt expense.
Total
segment assets for IB-STIM amounted to $ 7,087,999 and $ 4,757,572 as of June 30, 2025 and December 31, 2024, respectively. Total segment
capital expenditures for IB-STIM amounted to $ 7,288 and $ 8,686 for the three months ended June 30, 2025 and 2024, respectively, and $ 25,288
and $ 23,408 for the six months ended June 30, 2025 and 2024, respectively. Total segment depreciation and amortization amounted to $ 12,885
and $ 10,970 for the three months ended June 30, 2025 and 2024, respectively, and $ 19,241 and $ 21,707 for the six months ended June 30,
2025 and 2024, respectively.
Significant
segment non-cash charges settled in common stock include consulting and advisory fees totaling $ 0 and $ 85,731 for the three months ended
June 30, 2025, and 2024, respectively, and $ 112,493 and $ 285,981 for the six months ended June 30, 2025 and 2024, respectively.
13.
Settled Litigation
On
February 6, 2019, plaintiff Ritu Bhambhani, 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 stated 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. On June 3,
2024, the Fourth Circuit denied the plaintiff’s appeal and entered judgment against the plaintiffs. On June 25, 2024, the Fourth
Circuit entered its mandate declaring that its judgment against the plaintiffs took effect that day. The plaintiffs did not seek any
further review or appeal of that judgment.
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Also
on July 14, 2022, plaintiffs Ritu Bhambhani, LLC; Box Hill Surgery Center, LLC; Pain and Spine Specialists of Maryland, LLC; and SimCare
ASC, LLC initiated a lawsuit against the Company and others in the United States District Court for the District of Maryland. The plaintiffs
in this lawsuit are business entities owned or partially owned by the plaintiffs that initiated the litigation described above. The Complaint
asserted claims under the RICO Act, as well as fraudulent misrepresentation, intentional misrepresentation by concealment, and civil
conspiracy and seeks compensatory damages in excess of $ 75,000 , pre-judgment interest, punitive damages, attorney’s fees, and court
costs. The Complaint states that the Company, distributors of the Company’s product, and medical billing and coding consultants
allegedly made misrepresentations to the plaintiffs that the Company’s NeuroStim device and related procedures could be billed
to, and reimbursed by, Medicare and other insurance payors as a surgically implantable neurostimulator. Plaintiffs claim to have suffered
damages when Medicare administrative contractors declined to pay plaintiffs for their use of the device.
On
September 28, 2022, the Company filed a motion to dismiss all claims. On May 25, 2023, the Court issued an Order and a Memorandum Opinion
which dismissed the plaintiffs’ claims related to the RICO Act. The remaining claims are still pending, and no trial date has been
set for the case. The Court has vacated its Scheduling Order at the parties’ request so that the parties could try to resolve the
disputes in both cases through an independent third-party mediator.
On
April 25, 2025, the parties reached a tentative $ 750,000 settlement payable in 12 equal monthly installments beginning in January of
2026 as filed with the United States District Court for the District of Maryland with the settlement agreement duly executed on May 15,
2025. The Company recorded a charge of $ 11,471 and $ 630,568 for the three and six months ended June 30, 2025, respectively, in the Condensed
Statements of Operations classified as general and administrative expense, while interest expense will be recorded as incurred. As of
June 30, 2025, the Company accrued $ 375,000 as accrued expenses and $ 267,540 as other non-current liabilities in the Condensed Balance
Sheets.
14.
Commitments and Contingencies
Manufacturing
Services Agreement
The
Company is party to a manufacturing services agreement for the manufacture and supply of the Company’s IB-STIM device based on
the Company’s product specifications that automatically renews annually unless either party provides a written termination notice
to the other party within 180 days prior to the end of the then-current term. 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 agreement is initiated by orders issued by the Company and accepted by the manufacturer.
Advisory
Agreement
On
March 18, 2024, the Company terminated its private placement services agreement and entered into an advisory agreement for debt, equity
and public securities market services for one year. The advisory agreement included a monthly fee of $ 30,000 and 7,563 common stock warrants
to be issued monthly at an exercise price of $ 2.38 with a term of five years. On December 31, 2024, the Company and the financial advisor
terminated the advisory agreement subject to the cancelation of 30,252 common stock warrants issued after July 2024 and the payment for
services rendered totaling $ 180,000 during the three months ended March 31, 2025.
Settlement
Agreements
The
Company settled a 2023 convertible note dispute with an existing shareholder for $ 230,824 during the six months ended June 30, 2024.
The Board approved the issuance of 53,063 common shares on April 4, 2024 as consideration in lieu of payment recorded as financing charges
in the Condensed Statements of Operations.
On
June 28, 2024, the Company issued 90,032 shares of common stock to various pre-IPO Series A Preferred Stock shareholders to settle certain
claims. The Company recorded the fair value of the settlements totaling $ 286,458 for the three and six months ended June 30, 2024, as
Other Expense in the Condensed Statements of Operations. Furthermore, the Company authorized the issuance of 104,378 shares of its common
stock to settle the remaining claims with pre-IPO Series A Preferred Stock shareholders recorded at a fair value of $ 290,171 for the
three and six months ended June 30, 2024, as Other Expense in the Condensed Statements of Operations and Accrued Expenses in the Condensed
Balance Sheets as of June 30, 2024. As of June 30, 2025, 1,518 shares of common stock authorized to settle these claims with a fair value
of $ 4,220 have not yet been issued as of the reporting date as the Company awaits execution of the settlement agreement by one counterparty.
There were no shares of common stock issued to settle any claims during the three and six
months ended June 30, 2025.
Executive
Employment Agreements
The
Company, as authorized by the board of directors, entered into employment agreements with certain 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 two 2
to five years and optional one-year renewals .
There
are seven key employees that have stock options of the Company totaling 1,238,712 shares. These key employees have a provision in their
agreements whereas the Company will pay a special bonus equal to the aggregate of the strike price or exercise price of all their stock
options plus a tax gross-up payment. The special bonus shall be paid in twenty percent ( 20 %) installments starting January 2, 2024, and
the same date each of the next four years. As a condition of the payment, the key employee must exercise at least 20 % of their stated
number of stock options. There are additional provisions to cover termination and change of control events.
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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
special options bonuses of $ 14,821,830 were contingent upon a successful initial public offering and will be recorded when paid.
On
April 10, 2024, the employment of the Company’s Chief Operating Officer was terminated. Pursuant to the employment agreement, the
Company (i) made salary continuation payments based on an annual salary of $ 275,000 through October 10, 2024, (ii) issued 25,832 shares
of common stock at a fair value of $ 78,788 and (iii) made a $ 41,980 one-time payment in lieu of the exercise of 13,764 stock options
that expired on January 2, 2024. The Company is contracted to provide health care coverage through October 2025 and has accrued for that
obligation totaling $ 10,281 and $ 21,418 classified as Accrued Expenses in the Condensed Balance Sheets as of June 30, 2025 and December
31, 2024, respectively.
Threatened
Litigation
From
time to time, the Company may be involved in litigation relating to claims arising out of operations in the normal course of business.
As of the date of issuance, other than those described above (see Footnote 13), there were no pending or threatened legal proceedings
that could reasonably be expected to have a material effect on the results of the Company’s operations. There are also no proceedings
in which any of the Company’s directors, officers or affiliates is an adverse party to the Company or has a material interest adverse
to the Company’s interest. Legal fees are expensed as incurred.
In
January 2024, Dr. Arturo Taca served notice to the Company that asserted an interest in its U.S. Patent No. 10,413,719 valued at $ 2,000,000
based on his own work in neurostimulation. The Company denied both the neurostimulation patent and compensation claims. The case remains
unresolved. While it is too early to predict the ultimate outcome of this matter, we believe the Company has meritorious defenses and
intends to defend this matter vigorously.
15.
Subsequent Events
On
July 1, 2025, the Company terminated the NSS-2 Bridge license with Masimo in exchange for $ 200,000 of consideration payable in equal
installments on December 31, 2025 and June 30, 2026. The termination agreement allowed the Company to recapture the rights to the trademark
(U.S. Registration No. 7,394,465) and two patent applications (Application No. 18/821,225 and Application No. 29/960,608) that were licensed
to Masimo on April 9, 2020 for use in the reduction of the symptoms of opioid withdrawal.
On July 1, 2025, the Compensation Committee of
the Board of Directors (“Board”) of the Company adopted the NeurAxis, Inc. 2025 Employee Stock Purchase Plan (the “ESPP”),
effective as of the same date and subject to Shareholder approval by July 1, 2026. The purpose of the ESPP is to provide eligible employees
an opportunity to acquire common stock of the Company at a 15 % discount using payroll deductions. The maximum number of shares
of the Company’s common stock that may be issued under the ESPP is 100,000, subject to an annual increase on January 1st of each year
from 2026 through 2035 by the lesser of (i) 1% of the Company’s outstanding capital stock as of the prior December 31st or (ii) 100,000
shares. The Board may reduce or eliminate this annual increase before February 1st of any given year.
The
Company has evaluated subsequent events through the filing of this Quarterly Report on Form 10-Q and determined that there have been
no other events that have occurred that would require adjustments to our disclosures in the condensed financial statements.
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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.