Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
NeurAxis,
Inc.
Condensed
Balance Sheets
March
31,
2025
December
31,
2024
(Unaudited)
Assets
Current Assets:
Cash and cash
equivalents
$ 2,005,370
$ 3,696,870
Accounts receivable, net
of credit losses of $ 5,000 and $ 5,000 as of March 31, 2025 and December 31, 2024, respectively
243,708
244,618
Inventories, net of
reserves of $ 4,454 and $ 4,454 as of March 31, 2025 and December 31, 2024, respectively
37,421
44,328
Prepaids
and other current assets
254,527
280,367
Total
current assets
2,541,026
4,266,183
Property and Equipment, at cost:
481,012
464,402
Less
- accumulated depreciation
( 377,297 )
( 374,420 )
Property
and equipment, net
103,715
89,982
Other Assets:
Operating lease right of
use asset, net
270,938
284,656
Intangible assets, net
93,967
96,588
Security
Deposit
20,163
20,163
Total
Assets
$ 3,029,809
$ 4,757,572
Liabilities
Current Liabilities:
Accounts payable
$ 535,017
$ 596,946
Accrued expenses
1,370,960
1,577,780
Current portion of operating
lease payable
65,900
62,754
Notes payable
84,307
154,152
Customer deposits
37,684
32,527
Warrant
liabilities
7,335
9,166
Total
current liabilities
2,101,203
2,433,325
Non-current Liabilities:
Operating
lease payable, net of current portion
238,530
256,499
Other non-current liabilities
431,597
—
Total
non-current liabilities
670,127
256,499
Total
liabilities
2,771,330
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, 4,280,939 shares issued and outstanding as of March 31, 2025 and December 31, 2024
4,281
4,281
Common stock, $ 0.001 par value; 100,000,000 shares authorized; 7,215,864
and 6,990,227 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively
7,216
6,990
Additional paid in capital
59,325,278
58,856,089
Accumulated deficit
( 59,078,296 )
( 56,799,612 )
Total
stockholders’ equity
258,479
2,067,748
Total
Liabilities and Stockholders’ Equity
$ 3,029,809
$ 4,757,572
The
accompanying notes are an integral part of these unaudited condensed financial statements
3
NeurAxis,
Inc.
Condensed
Statements of Operations (Unaudited)
2025
2024
For
the Three Months Ended
March
31,
2025
2024
Net Sales
$ 895,655
$ 646,635
Cost of Goods Sold
139,475
75,081
Gross Profit
756,180
571,554
Selling Expenses
133,954
80,030
Research and Development
60,556
5,570
General and Administrative
2,856,768
2,318,074
Operating
Loss
( 2,295,098 )
( 1,832,120 )
Other income (expense):
Financing charges
—
( 230,824 )
Interest expense
( 2,237 )
( 26,560 )
Change in fair value of
warrant liability
1,831
( 9,284 )
Amortization of debt discount
and issuance cost
—
( 21,683 )
Other income
16,820
—
Other
expense
—
( 180 )
Total
other income (expense), net
16,414
( 288,531 )
Net loss
( 2,278,684 )
( 2,120,651 )
Preferred
stock dividends
( 213,543 )
—
Net loss available to common
stockholders
$ ( 2,492,227 )
$ ( 2,120,651 )
Per-Share Data
Basic and diluted loss
per share
$ ( 0.33 )
$ ( 0.32 )
Weighted Average Common Shares Outstanding
Basic and diluted
7,463,578
6,550,567
The
accompanying notes are an integral part of these unaudited condensed financial statements
4
NeurAxis,
Inc.
Condensed
Statements of Stockholders’ Equity (Deficit) (Unaudited)
Shares
Amount
Shares
Amount
Capital
Deficit
(Deficit)
Convertible
Series B
Preferred Stock
Common
Stock
Additional
Paid In
Accumulated
Stockholder’s
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 )
Balances at January 1, 2025
4,280,939
$ 4,281
6,990,227
$ 6,990
$ 58,856,089
$ ( 56,799,612 )
$ 2,067,748
Balances
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
Issuance 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
The
accompanying notes are an integral part of these unaudited condensed financial statements
5
NeurAxis,
Inc.
Condensed
Statements of Cash Flows (Unaudited)
2025
2024
For
the Three Months Ended
March 31,
2025
2024
Cash Flows from Operating
Activities
Net Loss
$ ( 2,278,684 )
$ ( 2,120,651 )
Adjustments to reconcile
net loss to net cash used by operating activities:
Amortization of debt discount
and issuance cost
—
21,683
Depreciation and amortization
6,356
10,737
Provisions for losses on
accounts receivable
—
13,634
Loss on disposal of property and equipment
533
—
Non-cash lease expense
13,719
17,316
Stock-based compensation
105,811
227,000
Issuance of common stock
for non-cash consideration
—
50,062
Issuance of warrants for
non-cash consideration
—
15,543
Change in fair value of
warrant liabilities
( 1,831 )
9,284
Changes in operating assets
and liabilities:
Accounts receivable
910
( 31,001 )
Inventory
6,907
1,026
Prepaids and other current
assets
25,840
4,497
Accounts payable
( 61,931 )
32,821
Accrued expenses
156,784
415,394
Customer deposits
5,157
10,807
Operating
lease liability
( 14,823 )
( 10,312 )
Other non-current liabilities
431,597
—
Net
cash used in operating activities
( 1,603,655 )
( 1,332,160 )
Cash Flows from Investing
Activities
Additions
to property and equipment
( 18,000 )
( 14,722 )
Net
cash used in investing activities
( 18,000 )
( 14,722 )
Cash Flows from Financing
Activities
Proceeds from exercised warrants
—
26,180
Principal
payments on notes payable
( 69,845 )
( 51,606 )
Proceeds from convertible notes, net of fees
—
1,375,500
Net
cash (used in) provided by financing activities
( 69,845 )
1,350,074
Net (Decrease) Increase in Cash and
Cash Equivalents
( 1,691,500 )
3,192
Cash and Cash Equivalents
at Beginning of Period
3,696,870
78,560
Cash
and Cash Equivalents at End of Period
$ 2,005,370
$ 81,752
Supplemental Disclosure
of Operating Activities
Cash paid for interest
$ 2,237
$ 16,889
Cash paid for income taxes
—
—
Supplemental Schedule of
Non-Cash Investing and Financing Activities
Recognition of right of
use asset
$ —
$ 284,339
Common stock issued for
services
112,493
200,250
Common stock issued upon
cashless exercise of warrants
186
—
Fair value of warrants
from debt discount in convertible notes classified as additional paid in capital
—
97,465
The
accompanying notes are an integral part of these unaudited condensed financial statements
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 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. The IB-STIM currently is one of two products marketed and sold by the Company.
●
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. The NSS-2 Bridge device is licensed to Masimo Corporation. Masimo markets and sells this product as its Masimo Bridge.
●
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 following the requirements of the U.S. Securities and Exchange Commission (“SEC”)
for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by
U.S. GAAP can be condensed or omitted. These interim financial statements have been prepared on the same basis as the Company’s
annual financial statements and, in the opinion of management, reflect all adjustments which are necessary for a fair presentation of
the Company’s financial information. These unaudited interim results are not necessarily indicative of the results to be expected
for the year ending December 31, 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.
7
2.
Summary of Significant Accounting Policies
Use
of Estimates and Critical Accounting Estimates and Assumptions
The
preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S.
GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during
the reporting periods.
These
significant accounting estimates or assumptions bear the risk of change due to the fact that there are uncertainties attached to these
estimates or assumptions, and certain estimates or assumptions are difficult to measure or value.
Management
bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial
statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values
of assets and liabilities that are not readily apparent from other sources.
Management
regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes
in facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates
are adjusted accordingly. The Company uses estimates in accounting for, among other items, revenue recognition, allowance for credit
losses, stock-based compensation, income tax provisions, excess and obsolete inventory reserve, and impairment of property and equipment,
and intellectual property. Actual results could differ from those estimates.
Accounts
Receivable and Allowance for Credit Losses
Trade
accounts receivable are 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 March 31, 2025 and December 31, 2024, respectively. The Company recorded credit losses for the three months ended March 31, 2025
and 2024 of $ 0 and
$ 13,634 ,
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 three months ended March 31, 2025 and 2024, there was no expired inventory expensed. Inventory reserves
totaled $ 4,454 and $ 4,454 as of March 31, 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 March 31, 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.
8
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 March 31, 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 March 31, 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 month periods ended March 31, 2025 and 2024 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
March 31,
2025
2024
Options
1,319,394
1,319,394
Restricted Stock Units
842,214
—
Warrants
2,139,883
1,857,618
Series B Preferred Stock
4,280,939
—
Undeclared Cumulative Series B Preferred Stock Dividends
178,492
88,768
Totals
8,760,992
3,265,780
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
2025
2024
Three
Months Ended
March
31,
2025
2024
Numerator:
Net loss
$ ( 2,278,684 )
$ ( 2,120,651 )
Preferred
stock dividends
( 213,543 )
-
Net loss available to common stockholders
( 2,492,227 )
( 2,120,651 )
Denominator:
Weighted
average shares of common stock outstanding - basic and diluted
7,463,578
6,550,567
Basic and diluted net
loss per share
$ ( 0.33 )
$ ( 0.32 )
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.
9
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 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. Estimated returns totaled $ 6,587 and $ 5,000 as of March 31, 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 March 31, 2025, we had stockholders’
equity of $ 258,479 and short-term outstanding borrowings
of $ 84,307 . Additionally, we had cash of $ 2,005,370
and a working capital surplus of $ 439,823 as
of March 31, 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.
10
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 2023-19, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires the enhancement
of income tax disclosures to provide better insight into how an entity’s operations and related tax risks, planning and opportunities
affect its tax rate and prospects for future cash flows. The enhanced disclosures require (i) specific categories in a tabular rate reconciliation
including both amounts and percentages and (ii) additional information for reconciling items and income tax paid that meet a quantitative
threshold. Public business entities are required to adopt the standard for annual periods beginning after December 15, 2024. All other
entities are required to adopt the standard for annual periods beginning after December 15, 2025. The adoption of the standard is not
expected to have a material impact on the Company’s financial statements.
3.
Related Party Transactions
The
Company has two demand notes receivable from shareholders related to the sale of common stock on January 1, 2016. Both notes’ 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 March 31, 2025. The current loan balances are as follows:
Schedule of Related Party Transactions
Loan
Interest
Interest
Receivable
Receivable
Income
March 31, 2025
Shareholder 1
$ 506,400
$ 99,640
$ 5,289
Shareholder 2
506,400
99,505
5,289
Principal Balance
1,012,800
199,145
10,578
Allowance for Collection
Risk
( 1,012,800 )
( 199,145 )
( 10,578 )
Net
Balance
$ —
$ —
$ —
Loan
Interest
Interest
Receivable
Receivable
Income
December 31, 2024
Shareholder 1
$ 506,400
$ 94,351
$ 23,413
Shareholder 2
506,400
94,216
23,413
Principal Balance
1,012,800
188,567
46,826
Allowance for Collection
Risk
( 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. The license costs totaled $ 1,317
and $ 0 for the three months
ended March 31, 2025 and 2024, respectively. The Company owed the limited liability company $ 210
and $ 0
that are included in accounts payable in the Condensed Balance Sheets as of March 31, 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 $ 10,000 for the year ended December 31,2025. The Company sold
IB-STIM devices for a total of $ 1,957 and $ 0 for the three months ended March 31, 2025 and 2024, respectively.
The
Company’s former Chief Financial Officer is contracted for services through a third-party public accounting firm. He is the firm’s
managing partner and majority shareholder. The firm is engaged by the Company to provide accounting and tax services on a continuous
basis. The services totaled $ 21,871 and $ 62,987 for the three months ended March 31, 2025 and 2024, respectively. The Company owed the
firm $ 2,710 and $ 4,173 that are included in accounts payable as of March 31, 2025 and December 31, 2024, respectively. 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
March 31, 2025
December 31, 2024
Prepaid insurance
$ 115,506
$ 186,028
Prepaid software subscriptions
46,003
39,834
Other
93,018
54,505
Total prepaids and other current assets
$ 254,527
$ 280,367
11
5.
Accrued Expenses
Accrued expenses consisted of the following:
Schedule of Accrued Expenses
March 31, 2025
December 31, 2024
Compensation and benefits
$ 961,461
$ 1,261,317
Settled litigation
187,500
-
Interest
66,648
66,648
Advisory fees
-
176,750
Other
155,351
73,065
Total accrued expenses
$ 1,370,960
$ 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 and maturing 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 (collectively referred to as the “2024 Promissory Notes”). The principal outstanding on
2024 Promissory Notes was $ 84,307 and $ 154,152 as of March 31, 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 forgoing, all principal amounts outstanding on the maturity
date will automatically convert into the Company’s Series B Preferred Stock. The Series B Preferred Stock is entitled to cumulative
dividends at 8.5 % per annum (whether or not declared) payable quarterly in either cash or common stock at the $ 2.38 conversion price
at the election of the Company. Upon conversion to Series B Preferred Stock, the investor may elect, at its option at any time, to convert
all or part of the Series B Preferred Stock plus accrued but unpaid dividends into an equivalent amount of common stock at the $ 2.38
conversion price.
12
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 $ 21,683 for the three months ended March 31, 2024. There was no amortization of the debt
discount for the three months ended March 31, 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 $ 2,237 and $ 26,560 for the three months ended March 31, 2025 and 2024, respectively. The Company’s accrued interest
totaled $ 66,648 as of March 31, 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 at March 31, 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 31 st 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 %. As long as the Company is not in default, it is only obligated
to pay an amount equal to 50% of the monthly base rent for the first 10 months of the term .
The
Company recognized operating lease expense of $ 25,523 and $ 25,756 for the three months ended March 31, 2025 and 2024, respectively, including
short-term lease expense and variable lease costs.
13
The
following table presents information related to the Company’s operating leases:
Schedule of Operating Leases
March 31,
2025
December 31,
2024
Operating lease right-of-use assets
$ 270,938
$ 284,656
Other current liabilities
65,900
62,754
Operating lease liabilities
238,530
256,499
Total
$ 304,430
$ 319,253
Weighted-average remaining lease term (in years)
3.88
2.75
Weighted-average discount rate
15.0 %
15.0 %
As
of March 31, 2025, the maturities of the Company’s operating lease liabilities were as follows:
Schedule of Maturities Operating Lease Liabilities
2026
$ 105,874
2027
102,794
2028
87,399
2029
89,586
2030
15,210
Total lease payments
400,863
Less: imputed interest
( 96,433 )
Total present value of lease payments
$ 304,430
8.
Common Stock and Warrants
The
Company authorized 100,000,000 shares of common stock, of which 7,215,864 and 6,990,227 shares were issued and outstanding as of March
31, 2025 and December 31, 2024, respectively.
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 March 31, 2024, the Company issued (i) 11,000 common shares upon the exercise of warrants for $ 26,180 , (ii) 75,000
shares as payment to a vendor for services.
14
The
following is a summary of warrant activity for common stock during the three months ended March 31, 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
( 502,647 )
2.38
3.07
Outstanding as of March 31, 2025
2,139,883
$ 2.10
2.80
The
following table summarizes the Company’s warrants outstanding and exercisable as of March 31, 2025:
Schedule of Warrants outstanding and Exercisable
Number of
Warrants
Exercise
Expiration
Outstanding
Price
Date
Investor Warrant
12,852
$ 8.76
September 18, 2028
Investor Warrant
289,779
$ 0.01
None
2022 Convertible Notes
280,008
$ 2.38
Various in 2027
2023 Convertible Notes
1,149,586
$ 2.38
Various in 2028
Underwriter Warrants
331,146
$ 2.38
August 8, 2028
Advisory Agreement Warrants
76,512
$ 2.38
Various in 2029
2,139,883
15
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 4,280,939 shares issued and outstanding as of March 31, 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 .
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 March 31, 2025 and December 31, 2024, there were no preferred stock dividends declared or paid. Series B Preferred Stock undeclared
cumulative dividends totaled $ 424,811 and $ 211,268 as of March 31, 2025 and December 31, 2024, respectively.
16
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 and March 4, 2025 to certain employees as follows:
Schedule
of Stock Non Option Activity
Number of
RSUs
Weighted Average Fair Value
Outstanding as of December 31, 2024
—
$ —
Granted
842,214
2.31
Outstanding as of March 31, 2025
842,214
$ 2.31
Vested as of March 31, 2025
—
—
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 March 31, 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 $ 105,811
and $ 227,000
for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, total unrecognized stock-compensation
expense relating to unvested stock awards granted under the Company’s share-based compensation plans amounted to $ 1,654,312 .
Stock
Options
The
following is a summary of the Company’s outstanding stock options as of March 31, 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 March 31, 2025
1,319,394
4.44
$ 6.94
$ —
Vested and Exercisable as of March 31, 2025
1,319,394
4.44
$ 6.94
$ —
There was no stock-based compensation expense related to stock options recorded for the three months ended March 31, 2025 and 2024.
17
11.
Warrant Liabilities
The
Company has evaluated financial instruments arising from warrants that are issued and outstanding as of March 31, 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 84.5 % 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 3.84 % 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 months ended March 31, 2025 and 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
( 1,831 )
Warrant liabilities as of March 31, 2025
$ 7,335
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. IB-STIM currently is the
only product marketed and sold by the Company. 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 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.
18
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
Three months ended March 31,
2025
2024
Net Revenue
$ 895,655
$ 646,635
COGS
139,475
75,081
Gross Profit
756,180
571,554
Selling Expenses (a)
133,954
80,030
Research & Development (a)
60,556
5,570
Compensation and Benefits (a)
1,345,454
1,298,331
Professional Services (a)
406,716
548,467
Other Operating Expenses (a) (b)
1,104,598
471,276
Segment Operating Loss
( 2,295,098 )
( 1,832,120 )
Financing Charges
-
( 230,824 )
Interest Expense
( 2,237 )
( 26,560 )
Change in Fair Value of Warrant Liability
1,831
( 9,284 )
Amortization of Debt Discount and Issuance Cost
-
( 21,683 )
Other Income
16,820
-
Other Expense
-
( 180 )
Total Other (Expense) Income, Net
16,414
( 288,531 )
Net Loss
$ ( 2,278,684 )
$ ( 2,120,651 )
(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 $ 3,029,809 and $ 4,757,572 as of March 31, 2025 and December 31, 2024, respectively. Total segment
capital expenditures for IB-STIM amounted to $ 18,000 and $ 14,722 for the three months ended March 31, 2025 and 2024, respectively. Total
segment depreciation and amortization amounted to $ 6,356 and $ 10,737 for the three months ended March 31, 2025 and 2024, respectively.
Significant
segment non-cash charges settled in common stock include (i) consulting and advisory fees totaling $ 112,493 and $ 200,250 for the three
months ended March 31, 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.
19
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. The Company recorded a charge of $ 619,097
classified as general and administrative expense in the Condensed Statements of Operations during the three months ended March 31,
2025, while interest expense will be recorded as incurred. As of March 31, 2025, the Company accrued $ 187,500
as accrued expenses and $ 431,597
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 all 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 three months ended March 31, 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. There were no shares of common stock issued to settle any claims during the three months ended
March 31, 2025.
Furthermore,
the Company authorized the issuance of 1,518 shares of its common stock to settle remaining claims with pre-IPO Series A Preferred Stock
shareholders classified as $ 4,220 of other expense for the three months ended June 30, 2024 in the Condensed Statements of Operations
and accrued expenses in the Condensed Balance Sheets as of March 31, 2025 and December 31, 2024. These common shares have not yet been
issued as of the reporting date as the Company awaits execution of the settlement agreements by the counterparties. There are no further
settlement obligations as of March 31, 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 2
to 5
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.
20
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 $ 15,421 and $ 21,418 classified as Accrued Expenses in the Condensed Balance Sheets as of March 31, 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 below and in note 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
April 25, 2025, the parties reached a tentative $ 750,000
settlement payable in 12 equal monthly installments beginning in January of 2026. The Company recorded a charge of $ 619,097
classified as general and administrative expense in the Condensed Statements of Operations during the three months ended March 31,
2025, while interest expense will be recorded as incurred. As of March 31, 2025, the Company accrued $ 187,500
as accrued expenses and $ 431,597
as other non-current liabilities in the Condensed Balance Sheets.
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.