Neuraxis, INC 10-Q

ITEM 1. FINANCIAL STATEMENTS NeurAxis, Inc. Condensed Balance Sheets September 30, 2024 December 31, 2023 (Unaudited) Assets Current Assets: Cash and cash equivalents $ 260,885 $ 78,560 Accounts receivable, net 52,594 73,167 Inventories, net 22,458 21,220 Prepaids and other current assets 295,905 69,663 Total current assets 631,842 242,610 Property and Equipment, at cost: 464,402 436,626 Less - accumulated depreciation ( 370,189 ) ( 348,074 ) Property and equipment, net 94,213 88,552 Other Assets: Operating lease right of use asset, net 297,842 70,263 Intangible assets, net 99,209 108,073 Security Deposit 20,163 — Total Assets $ 1,143,269 $ 509,498 Liabilities Current Liabilities: Accounts payable $ 962,106 $ 1,204,219 Accrued expenses 1,169,774 401,088 Current portion of operating lease payable 56,387 49,127 Notes payable 147,688 148,062 Customer deposits 84,512 74,947 Share liability 227,000 — Warrant liabilities 16,659 8,225 Total current liabilities 2,664,126 1,885,668 Non-current Liabilities: Operating lease payable, net of current portion 273,075 27,071 Total non-current liabilities 273,075 27,071 Total liabilities 2,937,201 1,912,739 Commitments and contingencies (see note 12) — — Stockholders’ Deficit Convertible Series A Preferred stock, $ 0.001 par value; 0 and 1,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively — — Convertible Series Seed Preferred stock, $ 0.001 par value; 0 and 120,000 shares authorized; 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively — — Convertible Series B Preferred stock, $ 0.01 par value; 4,000,000 shares authorized, 2,073,524 and 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 2,074 — Preferred stock, value Common stock, $ 0.001 par value; 100,000,000 shares authorized; 6,980,227 and 6,508,897 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 6,980 6,509 Additional paid in capital 53,548,720 47,148,361 Accumulated deficit ( 55,351,706 ) ( 48,558,111 ) Total Stockholders’ Deficit ( 1,793,932 ) ( 1,403,241 ) Total Liabilities and Stockholders’ Deficit $ 1,143,269 $ 509,498 The accompanying notes are an integral part of these unaudited condensed financial statements 3 NeurAxis, Inc. Condensed Statements of Operations (Unaudited) 2024 2023 2024 2023 For the Three Months Ended September 30, For the Nine Months Ended September 30, 2024 2023 2024 2023 Net Sales $ 666,625 $ 477,460 $ 1,924,760 $ 1,928,590 Cost of Goods Sold 97,050 67,287 256,949 231,000 Gross Profit 569,575 410,173 1,667,811 1,697,590 Selling Expenses 95,430 64,210 226,374 250,933 Research and Development 72,422 44,950 132,304 171,536 General and Administrative 2,052,996 3,323,352 6,999,358 6,316,411 Operating Loss ( 1,651,273 ) ( 3,022,339 ) ( 5,690,225 ) ( 5,041,290 ) Other (Expense) Income: Financing charges — — ( 230,824 ) ( 2,772 ) Interest expense ( 64,676 ) ( 102,628 ) ( 171,934 ) ( 453,869 ) Interest income — 2,103 — 2,103 Change in fair value of warrant liability ( 6,726 ) 592,853 ( 8,434 ) 791,610 Change in fair value of derivative financial instruments — 6,394 — 198,551 Amortization of debt discount and issuance cost ( 40,888 ) ( 1,331,030 ) ( 126,387 ) ( 4,881,622 ) Extinguishment of debt liabilities — ( 4,779,069 ) — ( 3,649,571 ) Other income 17,072 9,931 20,032 11,483 Other expense ( 8,743 ) ( 1,578 ) ( 585,824 ) ( 9,008 ) Total other (expense) income, net ( 103,961 ) ( 5,603,024 ) ( 1,103,371 ) ( 7,993,095 ) Net Loss $ ( 1,755,234 ) $ ( 8,625,363 ) $ ( 6,793,596 ) $ ( 13,034,385 ) Per-Share Data Basic and diluted loss per share $ ( 0.25 ) $ ( 2.38 ) $ ( 1.01 ) $ ( 5.11 ) Weighted Average Common Shares Outstanding Basic and diluted 7,172,229 3,625,519 6,800,810 2,552,007 The accompanying notes are an integral part of these unaudited condensed financial statements 4 NeurAxis, Inc. Condensed Statements of Stockholders’ Deficit (Unaudited) Shares Amount Shares Amount Shares Amount Capital Deficit Deficit For the Three and Nine Months Ended September 30, 2023 Convertible Series A Preferred Stock Convertible Series Seed Preferred Stock Common Stock Additional Paid In Accumulated Stockholder’s Shares Amount Shares Amount Shares Amount Capital Deficit Deficit Balance at January 1, 2023 506,637 $ 507 115,477 $ 115 - 1,963,322 $ 1,963 $ 28,355,230 $ ( 33,931,428 ) $ ( 5,573,613 ) Net loss — — — — - — — — ( 2,173,408 ) ( 2,173,408 ) Balance at March 31, 2023 506,637 $ 507 115,477 $ 115 - 1,963,322 $ 1,963 $ 28,355,230 $ ( 36,104,836 ) $ ( 7,747,021 ) Net loss — — — — - — — — ( 2,235,614 ) ( 2,235,614 ) Balance at June 30, 2023 506,637 $ 507 115,477 $ 115 - 1,963,322 $ 1,963 $ 28,355,230 $ ( 38,340,450 ) $ ( 9,982,635 ) Common stock issued upon initial public offering, net — — — — 1,098,667 1,099 4,859,622 — 4,860,721 Common stock issued upon preferred stock conversion ( 506,637 ) ( 507 ) ( 115,477 ) ( 115 ) 167,986 168 ( 622 ) — ( 1,076 ) Common stock issued upon debt conversion — — — — 1,494,359 1,494 8,964,765 — 8,966,259 Common stock issued from agreements — — — — 425,000 425 ( 425 ) — — Change in fair value of warrant liability upon initial public offering — — — — — — 3,721,007 — 3,721,007 Net loss — — — — - — — — ( 8,625,363 ) ( 8,625,363 ) Balances at September 30, 2023 — $ — — $ — - 5,149,334 $ 5,149 $ 45,899,577 $ ( 46,965,813 ) $ ( 1,061,087 ) 5 NeurAxis, Inc. Condensed Statements of Stockholders’ Deficit (Unaudited) Shares Amount Shares Amount Shares Amount APIC Deficit Deficit For the Three and Nine Months Ended September 30, 2024 Convertible Series A Preferred Stock Convertible Series Seed Preferred Stock Convertible Series B Preferred Stock Common Stock Additional Paid In Accumulated Stockholder’s Shares Amount Shares Amount Shares Amount Shares Amount Capital Deficit Deficit Balance at January 1, 2024 — $ — — $ — — $ — 6,508,897 $ 6,509 47,148,361 $ ( 48,558,111 ) $ ( 1,403,241 ) Balance — $ — — $ — — $ — 6,508,897 $ 6,509 47,148,361 $ ( 48,558,111 ) $ ( 1,403,241 ) Warrants exercised — — — — — — 11,000 11 26,169 — 26,180 Additional paid in capital from warrants issued under consulting agreement — — — — — — — — 15,543 — 15,543 Additional paid in capital 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 ) Balance 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 ) Balances — $ — — $ — — $ — 6,841,621 $ 6,842 $ 48,331,248 $ ( 53,596,472 ) $ ( 5,258,382 ) Additional paid in capital from warrants issued under consulting agreement — — — — — — — — 65,426 — 65,426 Common stock issued from agreements — — — — — — 138,606 138 384,694 — 384,832 Debt discount on mandatory conversion of convertible promissory notes to Series B preferred shares — — — — — — — — ( 165,577 ) — ( 165,577 ) Conversion of convertible promissory note to Series B Preferred Stock — — — — 2,073,524 2,074 — — 4,932,929 — 4,935,003 Net loss — — — — — — — — — ( 1,755,234 ) ( 1,755,234 ) Balances at September 30, 2024 — $ — — $ — 2,073,524 $ 2,074 6,980,227 $ 6,980 $ 53,548,720 $ ( 55,351,706 ) $ ( 1,793,932 ) Balances — $ — — $ — 2,073,524 $ 2,074 6,980,227 $ 6,980 $ 53,548,720 $ ( 55,351,706 ) $ ( 1,793,932 ) The accompanying notes are an integral part of these unaudited condensed financial statements 6 NeurAxis, Inc. Condensed Statements of Cash Flows (Unaudited) 2024 2023 For the Nine Months Ended September 30, 2024 2023 Cash Flows from Operating Activities Net Loss $ ( 6,793,596 ) $ ( 13,034,385 ) Adjustments to reconcile net loss to net cash used by operating activities: Amortization of debt discount and issuance cost 126,387 4,881,622 Depreciation and amortization 30,980 30,290 Provisions for losses on accounts receivable 23,156 6,380 Provision for losses on inventory 2,030 — Non-cash lease expense 29,098 23,339 Non-cash interest expense — 260,777 Stock-based compensation 227,000 — Extinguishment of derivative liability — 3,649,571 Issuance of common stock for non-cash consideration 1,103,124 2,550,000 Fair value of warrants issued for non-cash consideration 125,824 — Finance charges 230,824 2,772 Change in fair value of derivative liabilities — ( 198,551 ) Change in fair value of warrant liabilities 8,434 ( 791,610 ) Changes in operating assets and liabilities: Accounts receivable ( 2,583 ) 35,637 Inventory ( 3,268 ) 13,603 Prepaids and other current assets 19,767 ( 37,967 ) Accounts payable ( 242,112 ) ( 1,025,467 ) Accrued expenses 768,686 ( 415,181 ) Customer deposits 9,565 9,798 Operating lease liability ( 3,413 ) ( 25,047 ) Net cash used by operating activities ( 4,340,097 ) ( 4,064,419 ) Cash Flows from Investing Activities Additions to property and equipment ( 27,776 ) ( 14,741 ) Additions to intangible assets — ( 41,000 ) Net cash used by investing activities ( 27,776 ) ( 55,741 ) Cash Flows from Financing Activities Proceeds from issuance of common stock, net of issuance costs — 5,464,642 Offering costs in advance of sale of common stock — ( 2,417,185 ) Proceeds from exercised warrants 26,180 — Principal payments on notes payable ( 216,482 ) ( 3,487,578 ) Proceeds from notes payable — 159,831 Proceeds from convertible notes, net of fees 4,740,500 4,908,000 Net cash provided by financing activities 4,550,198 4,627,710 Net Increase in Cash and Cash Equivalents 182,325 507,550 Cash and Cash Equivalents at Beginning of Period 78,560 253,699 Cash and Cash Equivalents at End of Period $ 260,885 $ 761,249 Supplemental Disclosure of Operating Activities Cash paid for interest $ 30,756 $ 192,015 Cash paid for income taxes — — Supplemental Schedule of Non-Cash Investing and Financing Activities Recognition of right of use asset $ 284,339 $ — Conversion of convertible promissory notes to Series B preferred stock 4,935,000 — Fair value of warrant liabilities from convertible notes — 2,446,502 Fair value of derivative liabilities of conversion feature from convertible notes — 2,375,378 Fair value of warrants from debt discount in convertible notes classified as additional paid in capital 97,465 — Write-off of debt discount on convertible notes classified as additional paid in capital 165,777 — Issuance of note payable to financing company for insurance premiums 216,110 — 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 on April 17, 2012, under the name of Innovative Health Solutions, Inc. The name was changed to NeurAxis, Inc. in March of 2022. Additionally, the Company filed a Certificate of Conversion to become a Delaware corporation on June 23, 2022. The authorized shares were increased, and a par value established. On January 10, 2023, the Company’s board of directors authorized a 1-for-2 reverse stock split . All per share information has been adjusted for this reverse stock split. The reverse split became effective on January 12, 2023. All share and per share amounts for the common stock have been retroactively restated to give effect to the splits. As part of the conversion to a Delaware corporation, the total number of shares of all classes of stock which the Corporation had authority to issue was (1) 100,000,000 shares of Common Stock, par value $ 0.001 per share (“Common Stock”) and (ii) 1,120,000 shares of Preferred Stock, par value $ 0.001 per share (“Preferred Stock”), 1,000,000 of which was designated as “Series A Preferred Stock” and 120,000 of which was designated as “Series Seed Preferred Stock” with the rights, preferences, powers, privileges and restrictions, qualifications and limitations set forth in this Article IV of the Delaware Certificate of Incorporation. All share amounts have been retroactively restated to give effect to these changes. On August 9, 2023, the Company consummated an initial public offering (“IPO”), conducted on a firm commitment basis, pursuant to which it sold 1,098,667 shares of its common stock at a price of $ 6.00 per share, resulting in gross proceeds to the Company of $ 6,592,002 . Net proceeds to the Company, after deducting underwriting discounts and commissions, 2022 deferred offering costs totaling $ 736,736 and offering expenses paid by the Company, were $ 4,110,721 . All shares sold in our IPO were registered pursuant to a registration statement on Form S-1 (File No. 333- 269179), as amended, declared effective by the SEC on August 9, 2023. Alexander Capital L.P. (“Alexander”) acted as sole book-running manager for the offering and Spartan Capital Securities, LLC acted as co-manager for the offering. The underwriters did not exercise their option to purchase up to an additional 164,801 shares of common stock. The Company paid the underwriters an underwriting discount of seven percent ( 7 %) of the amount raised in the offering. In addition, we also paid the underwriters a non-accountable expense allowance in the amount of 1 % (such 8 % in commissions and fees amounted to a total of $ 527,000 ) at closing, as well as $ 175,000 for the reimbursement of certain of the underwriters’ expenses. Additionally, as partial consideration for services rendered in connection with the offering, the Company issued Alexander unregistered warrants to purchase an aggregate of 65,921 shares of Company common stock, representing 6.0 % of the aggregate shares sold in the offering. The warrants have an initial exercise price of $ 7.20 per share (equal to 120 % of the offering price per share), have a term of five years from the commencement of sales in the offering, and are exercisable at any time. On August 15, 2024, the Company’s shareholders (i) 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 2,073,524 shares issued and outstanding as of September 30, 2024, (ii) retired 1,000,000 shares of Series A Preferred Stock and (iii) retired 120,000 shares of Series Seed Preferred Stock. The Company is headquartered in Carmel, Indiana. The Company specializes in the development, production, and sale of medical neuromodulation devices. The Company has developed three FDA cleared products, the IB-STIM (DEN180057, 2019), the NSS-2 Bridge (DEN170018, 2017), and the original 510(K) clearance (K140530, 2014). ● The IB-STIM is a percutaneous electrical nerve field stimulator (PENFS) device that is indicated in patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome. The IB-STIM currently is the only product marketed and sold by the Company. ● The NSS-2 Bridge is a percutaneous nerve field stimulator (PNFS) device indicated for use in the reduction of the symptoms of opioid withdrawal. The NSS-2 Bridge device was licensed to Masimo Corporation in April 2020, and the Company received a one-time licensing fee of $ 250,000 from Masimo. Masimo markets and sells this product as its Masimo Bridge, and the Company will not receive any further licensing payments or other revenue from this product. ● The original 510(K) device was the EAD, an electroacupuncture device, now called NeuroStim. The EAD is no longer being manufactured, sold or distributed but reserved only for research purposes. The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and following the requirements of the U.S. Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These interim financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments which are necessary for a fair presentation of the Company’s financial information. These unaudited interim results are not necessarily indicative of the results to be expected for the year ending December 31, 2024, or any other interim period or for any other future year. These unaudited financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2023. 8 2. Summary of Significant Accounting Policies Use of Estimates and Critical Accounting Estimates and Assumptions The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the reporting periods. These significant accounting estimates or assumptions bear the risk of change due to the fact that there are uncertainties attached to these estimates or assumptions, and certain estimates or assumptions are difficult to measure or value. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. The Company uses estimates in accounting for, among other items, revenue recognition, allowance for credit losses, stock-based compensation, income tax provisions, excess and obsolete inventory reserve, and impairment of property and equipment, and intellectual property. Actual results could differ from those estimates. Fair Value Measurements The Company accounts for financial instruments in accordance with ASC 820, Fair Value Measurements and Disclosures (“ASC 820”). ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820 are described below: Level 1 – Quoted prices (unadjusted) for identical unrestricted assets or liabilities in active markets that the reporting entity has the ability to access as of the measurement date. Level 2 – Significant other observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities: quoted prices in markets that are not active; or financial instruments for which all significant inputs are observable or can be corroborated by observable market date, either directly or indirectly. Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. These unobservable inputs reflect that reporting entity’s own assumptions about assumptions that market participants would use in pricing the asset or liability. Level 3 assets and liabilities include financial instruments whose value is determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value require significant management judgment or estimation. The Company’s Level 1 accounts include cash, accounts receivable, accounts payable, prepaids, and other current assets. Management believes the estimated fair value of these accounts on September 30, 2024 approximate their carrying value as reflected in the balance sheets due to the short-term nature of these instruments or the use of market interest rates for debt instruments. 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 September 30, 2024 and December 31, 2023. In addition to assets and liabilities that are recorded at fair value on a recurring basis, the Company’s assets and liabilities are also subject to nonrecurring fair value measurements. As of September 30, 2024 and December 31, 2023, the Company had no assets that were measured on a nonrecurring basis. Basic and Diluted Net Income (Loss) per Share Earnings or loss per share (“EPS”) is computed by dividing net income (loss), by the weighted average number of shares of common stock outstanding during the period. Diluted EPS is computed by dividing net income (loss) by the weighted average of all potentially dilutive shares of common stock that were outstanding during the periods presented. Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per common share is determined using the weighted-average number of common shares outstanding during the period, adjusted for the dilutive effect of common stock equivalents. In periods when losses are reported, which is the case for September 30, 2024 and 2023 presented in these financial statements, the weighted-average number of common shares outstanding excludes common stock equivalents because their inclusion would be anti-dilutive. The Company had the following potentially dilutive common stock equivalents at September 30, 2024 and 2023: Schedule of Dilutive Common Stock Equivalents 2024 2023 Options 1,319,394 1,319,394 Pre-Funded Warrants for Common Stock 289,779 — Warrants 1,613,217 1,788,012 Series B Preferred Stock 2,073,524 — Totals 5,295,914 3,107,406 The following table presents the calculation of the basic and diluted net loss per share: Schedule of Basic and Diluted Net Loss Per Share 2024 2023 2024 2023 Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Numerator: Net loss $ ( 1,755,234 ) $ ( 8,625,363 ) $ ( 6,793,596 ) $ ( 13,034,385 ) Preferred stock dividends ( 44,820 ) - ( 44,820 ) - Net income (loss) available to stockholders ( 1,800,054 ) ( 8,625,363 ) ( 6,838,416 ) ( 13,034,385 ) Denominator: Weighted average shares of common stock outstanding - basic and diluted 7,172,229 3,625,519 6,800,810 2,552,007 Basic and diluted net loss per share $ ( 0.25 ) $ ( 2.38 ) $ ( 1.01 ) $ ( 5.11 ) Revenue Recognition Neuraxis, Inc. specializes in the development, production, and sale of medical neuromodulation devices to healthcare providers primarily located in the United States. Patented and trademarked neuromodulation devices is the Company’s major product line. Products are generally transferred at a point in time (rather than over time). Essentially all the Company’s revenue is generated from purchase order contracts. 10 In accordance with FASB’s ASC 606, Revenue from Contracts with Customers, (“ASC 606”), the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company applies the five-step model to contracts when it determines that it is probable it will collect substantially all the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price, after consideration of variability and constraints, if any, that is allocated to the respective performance obligation when the performance obligation is satisfied. The Company estimates credit losses on accounts receivable by estimating expected credit losses over the contractual term of the receivable using a discounted cash flow method. When developing this estimate of expected credit losses, the Company considers all available information (past, current, and future) relevant to assessing the collectability of cash flows. The Company offers a Patient Assistance Program for patients without insurance coverage for IB-Stim. This program extends potential self-pay discounts for IB-Stim devices, based upon household income and size. Also, the Company offers providers an opt-in program to address adequate insurance claim payments on IB-Stim devices. This program may extend a rebate or invoice credit where the insurance payment and patient responsibility (i.e., deductible, co-payment, and/or co-insurance amounts required by the Payer) are less than the acquisition cost of the IB-Stim device. The Company recognizes revenue at such a time that collection of the amount due is assured. The following economic factors affect the nature, amount, timing, and uncertainty of the Company’s revenue and cash flows as indicated: Type of customer: Based on dollar amounts of revenue, essentially all of the goods sold by the Company are sold to healthcare customers including hospitals and clinics. Sales to healthcare customers lack seasonality and have a mild correlation with economic cycles. Geographical location of customers: Sales to customers located within the United States represent essentially all of the Company’s sales. Type of contract: Sales contracts consist of purchase order contracts that tend to be short-term (i.e., less than or equal to one year in duration). Company’s Performance Obligations with Customers: Timing of Satisfaction The Company typically satisfies its performance obligations as the goods are received at the customer’s destination. Goods that are shipped to customers are typically shipped FOB destination with freight prepaid by the Company. As such, ownership of goods in transit transfer to the customer when received and the Company bears the associated risks (e.g., loss, damage, delay). Shipping and handling costs are recorded as cost of goods sold in the Statement of Operations. 11 Significant Payment Terms Payment for goods sold by the Company is typically due after an invoice is sent to the customer, within 30 days. Invoices for goods are typically sent to customers within three calendar days of shipment. The Company does not offer discounts if the customer pays some or all of an invoiced amount prior to the due date. None of the Company’s contracts have a significant financing component. Nature Medical devices that the Company contracts to sell and transfer to customers are manufactured by one specific third-party manufacturer. The manufacturer is located within the state of Indiana. In no case does the Company act as an agent (i.e., the Company does not provide a service of arranging for another party to transfer goods to the customer). Returns, Refunds, etc. Orders may not be cancelled after shipment. Customers may return devices within 10 days of delivery if the goods are found to be defective, nonconforming, or otherwise do not meet the stated technical specifications. At the option of the customer, the Company shall either: ● Refund the price paid for any defective or nonconforming products. ● Supply and deliver to the customer replacement conforming products. ● Reimburse the customer for the cost of repairing any defective or nonconforming products. At the time revenue is recognized, the Company estimates expected returns and excludes those amounts from revenue. The Company also maintains appropriate accounts to reflect the effects of expected returns on the Company’s financial position and periodically adjusts those accounts to reflect its actual return experience. Going Concern We have incurred losses since inception and have funded our operations primarily with a combination of sales, debt, and the sale of capital stock. As of September 30, 2024, we had a stockholders’ deficit of $ 1,793,932 and short-term outstanding borrowings of $ 147,688 . As of September 30, 2024, we had cash of $ 260,885 and a working capital deficit of $ 2,032,284 . Our future capital requirements will depend upon many factors, including progress with developing, manufacturing, and marketing our technologies, the time and costs involved in preparing, filing, prosecuting, maintaining, and enforcing patent claims and other proprietary rights, our ability to establish collaborative arrangements, marketing activities and competing technological and market developments, including regulatory changes and overall economic conditions in our target markets. Our ability to generate revenue and achieve profitability requires us to successfully market and secure purchase orders for our products from customers currently identified in our sales pipeline and to new customers as well. The primary activity that will drive all customers and revenues is the adoption of insurance coverage by commercial insurance carriers nationally, which is a top priority of the Company. These activities, including our planned research and development efforts, will require significant uses of working capital through the rest of 2024 and beyond. 12 Management evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the date the financial statements are issued. To date, the Company has experienced operating losses and negative cash flows from operations. Management believes that increased sales and acceptance of their product by insurance providers will allow the Company to achieve profitability in the near term. While the Company believes in the viability of its strategy to further implement its business plan and generate sufficient revenues and in its ability to raise additional funds by way of a public or private offering of its debt or equity securities, there can be no assurance that it will be able to do so on reasonable terms, or at all. The ability of the Company to continue as a going concern is dependent upon its ability to further implement its business plan and generate sufficient revenues and its ability to raise additional funds by way of a public or private offering. Neither future cash generated from operating activities, nor management’s contingency plans to mitigate the risk and extend cash resources through the evaluation period, are considered probable. As a result, substantial doubt is deemed to exist about the Company’s ability to continue as a going concern. As we continue to incur losses, our transition to profitability is dependent upon achieving a level of revenues adequate to support its cost structure. We may never achieve profitability, and unless and until doing so, we intend to fund future operations through additional dilutive or nondilutive financing. There can be no assurances, however, that additional funding will be available on terms acceptable to us, if at all. The financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. Recently Issued Accounting Pronouncements In December 2023, the FASB issued ASU 2023-19, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires the enhancement of income tax disclosures to provide better insight into how an entity’s operations and related tax risks, planning and opportunities affect its tax rate and prospects for future cash flows. The enhanced disclosures require (i) specific categories in a tabular rate reconciliation including both amounts and percentages and (ii) additional information for reconciling items and income tax paid that meet a quantitative threshold. Public business entities are required to adopt the standard for annual periods beginning after December 15, 2024. All other entities are required to adopt the standard for annual periods beginning after December 15, 2025. The adoption of the standard is not expected to have a material impact on the Company’s financial statements. 3. Related Party Transactions The Company has two demand notes receivable from shareholders related to the sale of common stock on January 1, 2016. Both notes’ initial balances were $ 506,400 , with interest calculated monthly based on applicable federal rates. No payments have been received on the notes. Since repayment is not assured, the Company provided an allowance for the entire balance of principal and interest as of December 31, 2019. The current allowance is $ 1,012,800 as of September 30, 2024. The current loan balances are as follows: Schedule of Related Party Transactions Loan Interest Interest Receivable Receivable Income September 30, 2024 Shareholder 1 $ 506,400 $ 89,124 $ 18,186 Shareholder 2 506,400 88,990 18,186 1,012,800 178,114 36,372 Allowance for Collection Risk ( 1,012,800 ) ( 178,114 ) ( 36,372 ) Net Balance $ — $ — $ — 13 Loan Interest Interest Receivable Receivable Income December 31, 2023 Shareholder 1 $ 506,400 $ 70,938 $ 23,867 Shareholder 2 506,400 70,803 23,867 1,012,800 141,741 47,734 Allowance for Collection Risk ( 1,012,800 ) ( 141,741 ) ( 47,734 ) Net Balance $ — $ — $ — Mr. Bradley Mitch Watkins, Director, provided certain sales, marketing and commercialization consulting services to the Company prior to his appointment to the Board of Directors. For the nine months ended September 30, 2024 and 2023, the Company paid Mr. Watkins $ 0 and $ 10,000 , respectively, for these services. No amounts were owed to Mr. Watkins as of September 30, 2024 and December 31, 2023, respectively, for these services. The Company’s former Chief Financial Officer is contracted for services through a third-party public accounting firm. He is the firm’s managing partner and majority shareholder. The firm is engaged by the Company to provide accounting and tax services on a continuous basis. Fees paid for services were $ 148,106 and $ 304,158 for the nine months ended September 30, 2024 and 2023, respectively. The Company owed the firm for open invoices of $ 50,808 and $ 84,279 that are included in accounts payable as of September 30, 2024 and December 31, 2023, respectively. 4. Notes Payable The Company borrowed $ 250,000 on December 16, 2021, from Channel Partners Capital. The note called for 65 weekly payments of $ 4,923 with the final payment scheduled for March 16, 2023. The note’s interest rate computes to a nominal rate of 40.9 %. The principal outstanding as of January 1, 2022 was $ 244,048 . The Company borrowed $ 122,000 on September 16, 2022, to bring the principal balance back to $ 250,000 . After making scheduled payments, the Company borrowed $ 107,231 on May 24, 2023, to bring the principal balance back to $ 250,000 . The terms of the note are the same as the previous note with the final payment made on August 22, 2024. The principal outstanding as of September 30, 2024 and December 31, 2023 was zero and $ 148,062 , respectively. The Company believes that the advancement of additional funds is a minor modification to the terms of the existing loan since the difference in present value of the cash flows under the terms of the new loan is less than 10% of the present value of the remaining cash flows under the terms of the original loan. As a result, the modification was accounted for as a modification of debt. The lender was granted and assigned a continuing security interest in all the Company’s personal property assets including, but not limited to, business equipment, inventory, accounts, accounts receivable, intellectual property, chattel paper, instruments, deposit accounts, commercial tort claims, contract rights, licenses, claims, and general intangibles. On November 8, 2023, the Company entered into a Securities Purchase Agreement (“SPA”) with a shareholder for the issuance 1,260,504 shares of Series B Convertible Preferred Stock, par value $ 0.001 per share (the “Series B Preferred Stock”), for an aggregate purchase price of $ 3,000,000 paid in 15 monthly installments of $ 200,000 each, commencing on the later of January 10, 2024 or a date after stockholders approve an amendment to the Company’s Certificate of Incorporation to authorize the creation of the Series B Preferred Stock (the “Stockholder Approval”). The Series B Preferred Stock is convertible at any time into shares of common stock of the Company without any further consideration. Following the issuance of the Series B Preferred Stock, it will rank senior to the common stock with respect to payments upon the liquidation, dissolution and winding up of the Company. Due to a delay in Stockholder Approval, the Company amended the SPA on February 12, 2024 to issue a promissory note, due and payable on the earlier of 15 months or 12 months if the Series B Preferred Stock has not been authorized, convertible into Series B Preferred Stock with identical funding amounts and terms. In February and March of 2024, the Company entered into a series of convertible promissory notes totaling $ 3,135,000 with terms identical to the $ 3,000,000 convertible promissory note issued on February 12, 2024 (collectively referred to as the “Original 2024 Convertible Promissory Notes”). 14 The 2024 Original Convertible Promissory Notes bear interest at 8.5 % per annum payable quarterly in either cash or common stock at the election of the Company. At any time following the date of shareholder approval to authorize the creation of Series B Preferred Stock prior to the maturity date, the investor may elect to convert all or part of the principal into the Company’s Series B Preferred Stock at a conversion price per share equal to $ 2.38 . Without limiting the forgoing, all principal amounts outstanding on the maturity date will automatically convert into the Company’s Series B Preferred Stock. The Series B Preferred Stock is entitled to cumulative dividends at 8.5 % per annum (whether or not declared) payable quarterly in either cash or common stock at the $ 2.38 conversion price at the election of the Company. Upon conversion to Series B Preferred Stock, the investor may elect, at its option at any time, to convert all or part of the Series B Preferred Stock plus accrued but unpaid dividends into an equivalent amount of common stock at the $ 2.38 conversion price. As of September 30, 2024, no investor has converted any portion of the Original 2024 Convertible Notes into Series B Preferred Stock as the shareholders have not yet authorized its issuance. On May 21, 2024, the Company entered into three convertible promissory notes with related institutional accredited investors with terms similar to the Original 2024 Convertible Promissory Notes (collectively referred to as the “Amended 2024 Convertible Promissory Notes”) for an additional amount of $ 3,000,000 . Certain provisions to the SPA and Certificate of Designation previously issued on February 12, 2024 changed, including (i) the number of shares of preferred stock to be designated as Series B Preferred Stock was increased from 1,500,000 to 5,000,000 , (ii) the stated value of the Series B Preferred Stock was changed from $ 1.00 to $ 2.38 per share, (iii) the right to receive dividends will expire automatically on June 30, 2025, (iv) the liquidation rights will automatically expire on June 30, 2025, and (v) the number of shares of the common stock that a holder of Series B preferred stock is entitled to receive shall not exceed the maximum percentage chosen by the holder, which is initially set at between 4.99 % and 19.99 % until shareholder approval is obtained, of the number of outstanding shares of the common stock at the time of the conversion of the Series B preferred stock shares. The maturity date shall be on the earlier of (i) June 21, 2025, (ii) upon written demand occurring on or after March 21, 2025 in the event that the Series B preferred shares have not been duly authorized on or before such date, or (iii) immediately upon the occurrence of an event of default. Automatic conversion into shares of Series B preferred stock (at a conversion price of $ 2.38 per share) will occur following the date of shareholder approval. In the event the Company fails to obtain shareholder approval before August 15, 2024, rights exist to convert the outstanding amount into shares of the common stock, at a price per share of $ 2.38 . As of 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. 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 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 9, 2024, the Company entered into a promissory note to finance the premiums on its annual directors and officers insurance policy, bearing interest at a rate of 7.40 % per annum and maturing on June 9, 2025. The outstanding balance of $ 166,149 consisted of a $ 147,688 note payable and $ 18,461 in accounts payable on the condensed balance sheets as of September 30, 2024. The Company’s private placement agent fees included (i) 10% of the Original 2024 Convertible Promissory Notes funded principal amount and (ii) warrants calculated as 6.0% of the funded principal amount divided by the $2.38 exercise price. The fair value of the warrants of $97,465 were deferred as a financing fee and classified as additional paid in capital. The private placement agreement was terminated on March 18, 2024 pursuant to an new advisory agreement (See Note 12). Accrued interest totaled $ 66,648 and $ 66,648 as of September 30, 2024 and December 31, 2023, respectively. Interest expense totaled $ 64,676 and $ 102,628 for the three months ended September 30, 2024 and 2023, respectively, and $ 171,934 and $ 453,869 for the nine months ended September 30, 2024 and 2023, respectively. Amortization of the debt discount on the Amended 2024 Convertible Notes totaled $ 40,888 and $ 126,387 for the three and nine months ended September 30, 2024, respectively. Upon mandatory conversion of the Amended 2024 Convertible Promissory Notes to Series B Preferred Stock, the Company wrote off the amortized debt discount of $ 165,577 to additional paid in capital included in stockholder’s deficit on the condensed balance sheet. 5. Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and current and non-current lease liabilities, as applicable. 15 Operating lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate to discount lease payments, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. Prospectively, the Company will adjust the right-of-use assets for straight-line rent expense, or any incentives received and remeasure the lease liability at the net present value using the same incremental borrowing rate that was in effect as of the lease commencement or transition date. The Company has elected not to recognize leases with an original term of one year or less on the balance sheet. The Company typically only includes an initial lease term in its assessment of a lease arrangement. Options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. Certain leases may contain rent escalation clauses, either fixed or adjusted periodically for inflation of market rates, that are factored into the calculation of lease payments to the extent they are fixed and determinable at lease inception. The Company also has variable lease payments that do not depend on a rate or index, primarily for items such as common area maintenance and real estate taxes, which are recorded as expenses when incurred. Assumptions made by the Company at the commencement date are re-evaluated upon occurrence of certain events, including a lease modification. A lease modification results in a separate contract when the modification grants the lessee an additional right of use not included in the original lease and when lease payments increase commensurate with the standalone price for the additional right of use. When a lease modification results in a separate contract, it is accounted for in the same manner as a new lease. Entities may elect not to separate lease and non-lease components. The Company has elected to account for lease and non-lease components together as a single lease component for all underlying assets and allocate all the contract consideration to the lease component only. The Company’s leases are comprised of operating leases for office space. At the inception of the lease, the Company determines whether the lease contract conveys the right to control the use of identified property for a period of time in exchange for consideration. Leases are classified as operating or finance leases at the commencement date of the lease. Operating leases are recorded as operating lease right-of-use assets, other current liabilities, and operating lease liabilities in the Balance Sheets. The Company did not have any finance leases as of September 30, 2024 and December 31, 2023. The Company has two leases primarily consisting of office space in Versailles and Carmel, Indiana. The lease in Versailles started January 1, 2022 and has 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. The new lease in Carmel started January 1, 2024. The initial term is five years and five months. The monthly lease payment started at $ 6,721 with an annual increase of 2.5 %. As long as the Company is not in default, it is only obligated to pay an amount equal to 50% of the monthly base rent for months 1-10. For the nine months ended September 30, 2024 and 2023, the Company recognized $ 74,314 and $ 35,678 of operating lease expense, including short-term lease expense and variable lease costs. 16 The following table presents information related to the Company’s operating leases: Schedule of Operating Leases September 30, 2024 December 31, 2023 Operating lease right-of-use assets $ 297,842 $ 70,263 Other current liabilities 56,387 49,127 Operating lease liabilities 273,075 27,071 Total $ 329,462 $ 76,198 Weighted-average remaining lease term (in years) 4.35 3.75 Weighted-average discount rate 15.0 % 15.0 % As of September 30, 2024, the maturities of the Company’s operating lease liabilities were as follows: Schedule of Maturities Operating Lease Liabilities 2024 $ 22,203 2025 105,130 2026 108,106 2027 86,856 2028 89,027 Thereafter 38,025 Total lease payments 449,347 Less: imputed interest ( 119,885 ) Total present value of lease payments $ 329,462 6. Common Stock and Warrants The Company authorized 100,000,000 shares of common stock, of which 6,980,227 and 6,508,897 shares were issued and outstanding as of September 30, 2024 and December 31, 2023, respectively. In conjunction with 1,098,667 common shares issued upon the completion of the initial public offering on August 8, 2023, the Company also issued (i) 1,244,228 common shares upon conversion of 506,637 shares of Convertible Series A Preferred Stock and 115,477 shares of Convertible Series Seed Preferred Stock, (ii) 1,649,900 common shares upon conversion of convertible notes, (iii) 425,000 common shares as payment to vendors for services and (iv) 127,780 common shares upon the exercise of warrants. On January 10, 2023, the Company’s board of directors authorized a 2-for-1 reverse stock split . All share information in these financial statements has been adjusted for this reverse stock split. Comm on Stock Issuances On January 2, 2024, the Company issued 75,000 shares of common stock with a fair value of $ 200,250 pursuant to a consulting agreement related to the Company’s transition to a public company. As the term of the consulting agreement covers the full fiscal year ending December 31, 2024, the Company expensed $ 50,062 and $ 100,125 in the three month and nine months ended September 30, 2024, respectively, with the remaining $ 50,063 recorded in prepaids and other current assets in the condensed balance sheets as of September 30, 2024. On January 19, 2024, the Company received proceeds of $ 26,180 from an existing shareholder and issued 11,000 shares of common stock upon the exercise of a warrant agreement at $ 2.38 per share. 17 On April 11, 2024, the Company issued 53,063 shares of common stock to an existing shareholder to settle a convertible note dispute. The Company recorded the fair value of the settlement totaling $ 230,823 as financing charge in the condensed statements of operations. On June 28, 2024 the Company issued 90,032 shares of common stock to pre-IPO Series A Preferred Shareholders to settle certain claims. The Company recorded the fair value of the settlement totaling $ 286,458 as other expense in the condensed statements of operations. On June 28, 2024, the Company issued 33,454 shares of common stock to holders of the Amended 2024 Convertible Promissory Notes in lieu of $ 79,588 in cash payments for interest through June 30, 2024. On June 28, 2024, the Company issued 24,343 shares of common stock to its Board of Directors for their service from the Company’s IPO on August 9, 2023 through March 31, 2024. The fair value of the services was recorded as general and administrative expense in the condensed statements of operations totaling $ 39,452 from August 9, 2023 through December 31, 2023 and $ 28,219 during the nine months ended September 30, 2024. On June 28, 2024, the Company issued 25,832 shares of common stock to its previous Chief Operating Officer in accordance with a severance agreement executed on April 10, 2024. The Company recorded the fair value of the severance provision totaling $ 78,788 as general and administrative expense in the condensed statements of operations. On June 28, 2024, the Company issued 20,000 shares of common stock to it previous CFO for services provided during the IPO. The Company recorded the fair value of the services totaling $ 55,600 as general and administrative expense in the condensed statements of operations. On August 22, 2024, the Company issued 25,601 shares of common stock to holders of the Amended 2024 Convertible Promissory Notes in lieu of $ 60,911 in cash payments for interest through August 22, 2024. On August 28, 2024 the Company issued 102,860 shares of common stock to pre-IPO Series A Preferred Shareholders to settle certain claims. The Company recorded the fair value of the settlement totaling $ 293,791 as other expense in the condensed statements of operations. On September 17, 2024, the Company issued 10,145 shares of common stock to a vendor pursuant to a marketing agreement. The Company recorded the fair value of services totaling $ 30,131 as general and administrative expense in the condensed statements of operations. Warrant Issuances In connection with a bridge loan, the Company issued a warrant on September 18, 2018 that allows the holder to purchase common stock from the Company at a share price of $ 4.38 per share. The number of shares was based on a formula tied to the final amount of loans made by the holder of $ 375,000 , multiplied by 150 %, and divided by $ 70.03 . The number of shares based on this formula is 12,852 . The warrant contains certain rights in the event of liquidation, merger, or consolidation of the Company. If the fair market value of one share is greater than the warrant price, the holder may elect to receive a number of shares equal to the value of the warrant. If the exercise is in connection with the sale of the Company, the holder may, at its option, condition its exercise of the warrant upon the consummation of such transaction. The warrant expires on September 18, 2028 and can be exercisable either in whole or from time to time in part prior to the expiration date. 18 The Company issued a second warrant on September 6, 2019, under similar terms but is a penny warrant that allows the holder to purchase 40,000 shares of common stock and is subject to adjustment for certain equity events. The warrant contains certain rights in the event of liquidation, merger, or consolidation of the Company. The warrant expires on September 6, 2029. This warrant was converted to 39,924 shares of common stock on December 28, 2023. The fair market value of the stock on that day was calculated as the average of the daily closing prices per share for the 30 consecutive trading day period ending on the second trading day prior to such date or $ 2.61 per share. Since the fair value was greater than the warrant price of $0.01 per share the holder elected to receive the number of shares equal to 40,000 times the difference between the fair market value and the exercise price divided by the fair market value, resulting in 39,924. The Company issued a third warrant to Masimo Corporation on April 9, 2020. This warrant was pre-funded in the amount of $ 2,734,340 . The warrant allows the holder to purchase 289,779 shares of Series A Preferred Stock at $ 9.44 per share and is subject to adjustment for certain equity events. The warrant contains certain rights in the event of liquidation, merger, or consolidation of the Company. There will be no additional purchase price for the Warrants. In the event that all outstanding shares of Series A Preferred Stock are converted, automatically or by action of the holders thereof, into Common Stock, including, without limitation, in connection with the Company’s initial, underwritten public offering and sale of its Common Stock pursuant to an effective registration statement under the Act, then from and after the date on which all outstanding shares of Series A Preferred Stock have been so converted, this Warrant shall be exercisable for such number of shares of Common Stock into which the Warrant Shares would have been converted had the Warrant Shares been outstanding on the date of such conversion, and the Exercise Price shall equal the Exercise Price in effect as of immediately prior to such conversion divided by the number of shares of Common Stock into which one share of Series A Preferred Stock would have been converted, all subject to further adjustment thereafter from time to time in accordance with the provisions of this Warrant. On August 14, 2023, the 144,890 Series A Preferred Stock warrants were converted to 289,779 common stock warrants. During 2022, the Company issued 793,655 five-year warrants to purchase common stock equal to one hundred percent (100%) of the shares into which the 2022 convertible notes can be converted at issuance. The 2024 Convertible Promissory Notes triggered the anti-dilution clause of the original agreement and decreased the exercise price to $ 2.38 . From March to June of 2023, the Company issued 505,570 one-year warrants to purchase common stock equal to fifty percent (50%) of the shares into which the 2023 convertible notes can be converted at issuance. The warrants have an exercise price of $ 5.25 per share. The 2024 Convertible Promissory Notes triggered the anti-dilution clause of the original agreement and decreased the exercise price to $ 2.38 . On August 9, 2023, the Company issued 122,202 five-year warrants to purchase common stock pursuant to an advisory agreement with a consulting firm upon closing of the Company’s initial public offering. The warrants have an exercise price of $ 6.00 per share. The 2024 Convertible Promissory Notes triggered the anti-dilution clause of the original agreement and decreased the exercise price to $ 2.38 . On August 14, 2023, the Company issued 186,156 five-year warrants to purchase common stock pursuant to an agreement with an underwriter upon closing of the Company’s initial public offering. The warrants have an exercise price of $ 7.20 per share. The 2024 Convertible Promissory Notes triggered the anti-dilution clause of the original agreement and decreased the exercise price to $ 2.38 . From January to March of 2024, the Company issued 38,697 warrants to its private placement agent in conjunction with the 2024 Convertible Promissory Notes at an exercise price of $ 2.38 to purchase common stock. The Company recorded the fair value of the services totaling $ 74,278 as financing fees in the condensed balance sheets as of September 30, 2024. From March to September of 2024, the Company issued 52,941 warrants pursuant to a capital markets advisory agreement at an exercise price of $ 2.38 to purchase common stock (See Note 12). The Company recorded the fair value of the advisory services totaling $ 125,824 as general and administrative expense in the condensed statements of operations. 19 The following is a summary of warrant activity for common stock during the periods ended September 30, 2024 and December 31, 2023: Schedule of Warrant Activity for Common Stock Number of Weighted-Avg. Weighted-Avg. Warrants for Exercise Remaining Common Stock Price Contractual Life Outstanding as of January 1, 2023 846,507 $ 5.06 4.72 Granted 813,928 5.81 4.38 Converted Prefunded Warrants 289,779 0.01 — Exercised ( 127,856 ) 2.38 — Outstanding as of December 31, 2023 1,822,358 $ 4.69 3.05 Granted 91,638 $ 2.38 4.60 Exercised ( 11,000 ) 2.38 — Outstanding as of September 30, 2024 1,902,996 $ 2.38 2.81 The following is a summary of warrant activity for preferred stock during the year ended December 31, 2023: Schedule of Warrant Activity for Preferred Stock Number of Weighted-Avg. Warrants for Exercise Preferred Stock Price Outstanding as of January 1, 2023 144,890 $ 0.01 Granted — — Cancelled/Expired — — Exercised ( 144,890 ) ( 0.01 ) Outstanding as of December 31, 2023 — $ — There was no preferred stock warrant activity for the three and nine months ended September 30, 2024. The following table summarizes the Company’s warrants outstanding and exercisable as of September 30, 2024: Schedule of Warrants outstanding and Exercisable Number of Warrants Exercise Expiration Outstanding Price Date Brian Hannasch W-01 12,852 $ 8.76 September 18, 2028 Masimo Corporation PSA-01 289,779 $ 0.01 None 2022 Convertible Notes 793,655 $ 2.38 Various 2023 Convertible Notes 537,949 $ 2.38 Various Consulting Agreement Warrants 202,840 $ 2.38 Various Underwriter’s Warrants 65,921 $ 2.38 August 8, 2028 1,902,996 20 7. 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 2,073,524 shares issued and outstanding as of September 30, 2024. 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. 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 September 30, 2024 and December 31, 2023, there were no preferred stock dividends declared or paid. Series B Preferred Stock un declared cumulative dividends totaled $ 44,820 and $ 0 as of September 30, 2024 and December 31, 2023, respectively. 21 8. Stock Options and Awards The following is a summary of stock option activity for the periods ended September 30, 2024 and December 31, 2023: Schedule of Stock Option Activity Weighted Avg. Number of Remaining Contractual Life Weighted Avg. Exercise Aggregate Intrinsic Options (in years) Price Value Outstanding as of January 1, 2023 1,319,394 6.69 $ 6.94 $ — Granted — — — — Forfeited — — — — Cancelled/Expired — — — — Exercised — — — — Outstanding as of December 31, 2023 1,319,394 5.69 $ 6.94 $ — Granted — — — — Forfeited — — — — Cancelled/Expired — — — — Exercised — — — — Outstanding as of September 30, 2024 1,319,394 4.94 $ 6.94 $ — Vested and Exercisable as of September 30, 2024 1,319,394 4.94 $ 6.94 $ — Stock-based compensation expense is classified in the Company’s statements of operations as general and administrative expense. Compensation expense totaled $ 227,000 and $ 0 for the nine months ended September 30, 2024 and 2023, respectively (See Note 9). As of September 30, 2024, there was no unrecognized compensation expense related to unvested options granted under the Company’s share-based compensation plans. 9. Share Liability As of September 30, 2024, the Company had not issued 100,000 shares of its common stock pursuant to a hiring grant of an executive officer, representing stock compensation expense of $ 227,000 in the nine months ended September 30, 2024 due to administrative delays. These shares are classified as share liabilities as they have been authorized but not yet issued as of the reporting date. On October 1, 2024, the Company amended the hiring grant and replaced the 100,000 unissued common shares with 100,000 restricted stock units that vest over three years . 10. Warrant Liabilities Management evaluates all of the Company’s financial instruments and contracts, including issued warrants to purchase its Class A common stock and Series B Preferred Stock, to determine if such instruments are liabilities or contain features that qualify as embedded derivatives, pursuant to ASC 480 and ASC 815-15. The classification of these financial instruments, including whether such instruments should be recorded as liabilities or as equity, is reassessed at the end of each reporting period. The Company utilizes a Black-Scholes option-pricing model for warrants that have an option to convert at a variable number of shares to compute the fair value 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 an expected remaining term of each warrant as of the valuation date, estimated volatility of 65.3 %, and a risk-free rate of 3.6 %. Risk-free interest rate: The Company uses the risk-free interest rate of a U.S. Treasury Note adjusted to be on a continuous return basis to align with the Black-Scholes option-pricing model. Dividend yield: The Company uses a 0 % expected dividend yield as the Company has not paid dividends to date and does not anticipate declaring dividends in the near future. Volatility: The Company calculates the expected volatility based on comparable company’s historical stock prices with a look back period commensurate with the period to maturity. 22 Expected term: The Company’s remaining term is based on the remaining contractual maturity of the warrants. The following are the changes in the warrant liabilities during the periods ended September 30, 2024 and December 31, 2023. Schedule of Changes in Warrant Liabilities Level 1 Level 2 Level 3 Warrant liabilities as of January 1, 2023 $ — $ — $ 2,234,384 Addition — — 2,446,502 Changes in fair value of warrant liabilities — — ( 844,854 ) Reclassify to equity — — ( 3,827,807 ) Warrant liabilities as of December 31, 2023 — — 8,225 Changes in fair value of warrant liabilities — — 9,284 Warrant liabilities as of March 31, 2024 — — 17,509 Changes in fair value of warrant liabilities — — ( 7,576 ) Warrant liabilities as of June 30, 2024 — — 9,933 Changes in fair value of warrant liabilities — — 6,726 Warrant liabilities as of September 30, 2024 $ — $ — $ 16,659 11. Derivative Liabilities The Company accounts for derivative financial instruments as either equity or liabilities in accordance with ASC Topic 815, Derivatives and Hedging , or ASC 815, based on the characteristics and provisions of each instrument. Embedded derivatives are required to be bifurcated from the host instruments and recorded at fair value if the derivatives are not clearly and closely related to the host instruments on the date of issuance. Derivative instrument liabilities are classified in the balance sheets as current or non-current based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the balance sheet date. The Company identified derivative instruments arising from the conversion shares from convertible notes in Note 4 as of December 31, 2023. The Company utilizes a Monte Carlo simulation model for commitment shares that have an option to convert at a variable number of shares to compute the fair value of the derivative and to mark to market the fair value of the derivative at each balance sheet date. The inputs utilized in the application of the Monte Carlo model included a starting stock price of $ 9.20 per share, an expected remaining term of each warrant as of the valuation date, estimated volatility of 80.0 %, drift, and a risk-free rate ranging from 3.5 % to 5.5 %. Risk-free interest rate: The Company uses the risk-free interest rate of a U.S. Treasury Note adjusted to be on a continuous return basis to align with the Black-Scholes option-pricing model. Dividend yield: The Company uses a 0 % expected dividend yield as the Company has not paid dividends to date and does not anticipate declaring dividends in the near future. Volatility: The Company calculates the expected volatility based on comparable company’s historical stock prices with a look back period commensurate with the period to maturity. Expected term: The Company’s remaining term is based on the remaining contractual maturity of the warrants. 23 The following are the changes in the derivative liabilities during the year ended December 31, 2023. Schedule of Changes in Derivative Liabilities Level 1 Level 2 Level 3 Derivative liabilities as of January 1, 2023 $ — $ — $ 1,735,700 Addition — — 2,375,378 Changes in fair value of derivative liabilities — — ( 198,551 ) Extinguishment of derivative liabilities — — ( 3,912,527 ) Derivative liabilities as of December 31, 2023 $ — $ — $ — There was no derivative liability activity for the three and nine months ended September 30, 2024. 12 . Commitments and Contingencies Manufacturing Services Agreement On August 21, 2020, the Company entered into a Manufacturing Services Agreement (MSA) for the manufacture and supply of the Company’s IB-STIM device based upon the Company’s product specifications as set forth in the MSA. This agreement terminated any prior manufacturing agreements. The Company provides the necessary equipment to the manufacturer and retains ownership. The manufacturer bears the risk of loss of and damage to the equipment and consigned materials. Performance under the MSA is initiated by orders issued by the Company and accepted by the manufacturer. The term of the MSA is 24 months and shall automatically renew for renewal terms of twelve months unless either party provides a written termination notice to the other party within 180 days prior to the end of the then-current term. Advisory Agreement On March 18, 2024, the Company terminated its private placement services agreement and entered into an advisory agreement for debt, equity and public securities market services for one year. The advisory agreement includes a monthly fee of $ 30,000 and 7,563 common stock warrants to be issued monthly at an exercise price of $ 2.38 with a term of five years. Settlement Agreements The Company issued 102,860 and 192,892 shares of common stock for the three and nine months ended September 30, 2024, respectively, to various pre-IPO Series A Preferred Stock shareholders to settle certain claims. The Company recorded the fair value of the settlements totaling $ 293,791 and $ 580,249 for the three and nine months ended September 30, 2024, respectively, as other expense in the Condensed Statements of Operations (See Note 6). 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 $ 0 and $ 4,220 of other expense for the three and nine months ended September 30, 2024, respectively, in the Condensed Statements of Operations and accrued expenses in the Condensed Balance Sheets as of September 30, 2024. These common shares have not yet been issued as of the reporting date as the Company awaits execution of the settlement agreements by the counterparties. 24 Executive Employment Agreements The Company, as authorized by the board of directors, entered into employment agreements with nine key employees to provide incentives to improve shareholder value and to contribute to the growth and financial success of the Company. The agreements had an employment start date of October 1, 2022, with initial terms from 2 to 5 years and optional one-year renewals . The total base salaries for the nine key employees in the agreements are $ 1,920,000 per year with various provisions for annual increases. In addition to base salaries, eight of the employees have a provision for a special one-time incentive payment to be paid in a lump sum after the start date. The total amount of these special incentive payments is $ 1,100,000 . The special incentive payment amount includes any accrued backpay wages for the employee. That amount for backpay was $ 417,390 and was paid in 2023. There are seven key employees that have stock options of the Company totaling 1,238,712 shares. These key employees have a provision in their agreements whereas the Company will pay a special bonus equal to the aggregate of the strike price or exercise price of all their stock options plus a tax gross-up payment. The special bonus shall be paid in twenty percent ( 20 %) installments starting January 2, 2024, and the same date each of the next four years. As a condition of the payment, the key employee must exercise at least 20 % of their stated number of stock options. There are additional provisions to cover termination and change of control events. In April 2023, the Company amended the employee agreements to, among other things, clarify that the special one-time incentive payment and the deferred bonus are contingent upon the effective date of the planned initial public offering. The amendment also sets forth a process for executives to exercise the stock options in accordance with the terms of the stock option agreement in effect as of the date of the employment agreement and to clarify that there is no modification to the stock option agreements. The Company has recorded the backpay portion of the incentive bonus noted above. The balance of the incentive bonuses of $ 694,056 and the special options bonuses of $ 14,821,830 were contingent upon a successful initial public offering. The incentive bonuses have been paid in full while the special options bonuses will be recorded when paid. On April 10, 2024, the employment of the Company’s Chief Operating Officer was terminated. Pursuant to the employment agreement, the Company will (i) make salary continuation payments based on an annual salary of $ 275,000 through October 10, 2024, (ii) provide health care coverage through October 10, 2025, (iii) issue 25,832 shares of common stock at a fair value of $ 78,788 and (iv) make a $ 41,980 one-time payment in lieu of the exercise of 13,764 stock options that expired on January 2, 2024 . Litigation From time to time in the normal course of our business operations, we may become subject to litigation that may result in liability material to our financial condition as a whole or may negatively affect our operating results if changes to our business operations are required. The cost to defend such litigation may be significant and may require a significant diversion of our resources, and there is no guarantee that we will be able to successfully defend against any such litigation regardless of particular merits. There also may be adverse publicity associated with litigation that could negatively affect customer perception of our business, regardless of whether the allegations are valid or whether we are ultimately found liable. Insurance may not be available on favorable terms, at all, or in sufficient amounts to cover any liabilities with respect to these or other matters. A judgment or other liability in excess of our insurance coverage for any claims could adversely affect our business, financial condition and the results of our operations. On February 6, 2019, plaintiff Ritu Bharnbhani, M.D., initiated a lawsuit against Innovative Health Solutions, Inc. and others in the United States District Court for the District of Maryland. Plaintiffs Bhambhani and Sudhir Rao subsequently amended the complaint, with the Third Amended Complaint (“Complaint”) containing the most recent set of allegations. The Complaint asserted claims under the RICO Act, as well as of fraudulent misrepresentation, intentional misrepresentation by concealment, and civil conspiracy and sought compensatory damages in excess of $ 5 million, pre-judgment interest, punitive damages, attorney’s fees, court costs and designation of the case as a class action. The Complaint states that the Company, distributors of the Company’s product, and medical billing and coding consultants allegedly made misrepresentations to the plaintiffs that the Company’s NeuroStim device and related procedures could be billed to, and reimbursed by, Medicare and other insurance payors as a surgically implantable neurostimulator. Plaintiffs claim to have suffered damages when Medicare administrative contractors declined to pay plaintiffs for their use of the device. 25 On February 11, 2022, the Company filed a motion for summary judgment based upon the plaintiffs not being proper parties to assert claims against the Company. On June 14, 2022, the Court granted the Company’s motion for summary judgment and dismissed the Complaint. On July 14, 2022, plaintiffs Ritu Bhambhani and Sudhir Rao filed a notice of appeal with the Fourth Circuit Court of Appeals. The Company filed a motion to dismiss. On January 4, 2023, the Court issued an order that stated it was deferring a ruling on the motion to dismiss the appeal and that it would address those arguments at the same time that it addressed the substantive merits of the case. As of May 5, 2023, the parties have submitted their appellate briefs to the Fourth Circuit. No date has been set for either oral argument or for issuance of a decision by the court. While it is too early to predict the ultimate outcome of this matter, we continue to believe we have meritorious defenses, that the dismissal of the Complaint should be upheld, and intend to continue to defend this matter vigorously. On July 14, 2022, plaintiffs Ritu Bhambhani, LLC; Box Hill Surgery Center, LLC; Pain and Spine Specialists of Maryland, LLC; and SimCare ASC, LLC initiated a lawsuit against the Company and others in the United States District Court for the District of Maryland. The plaintiffs in this lawsuit are business entities owned or partially owned by the plaintiffs that initiated the litigation described above. The Complaint asserted claims under the RICO Act, as well as fraudulent misrepresentation, intentional misrepresentation by concealment, and civil conspiracy and seeks compensatory damages in excess of $ 75,000 , pre-judgment interest, punitive damages, attorney’s fees, and court costs. The Complaint states that the Company, distributors of the Company’s product, and medical billing and coding consultants allegedly made misrepresentations to the plaintiffs that the Company’s NeuroStim device and related procedures could be billed to, and reimbursed by, Medicare and other insurance payors as a surgically implantable neurostimulator. Plaintiffs claim to have suffered damages when Medicare administrative contractors declined to pay plaintiffs for their use of the device. On September 28, 2022, the Company filed a motion to dismiss all claims. On May 25, 2023, the Court issued an Order and a Memorandum Opinion which dismissed the plaintiff’s claims related to the RICO Act. The remaining claims are still pending, and no trial date has been set for the case. The Court has vacated its Scheduling Order at the parties’ request so that the parties could try to resolve the disputes in both cases through an independent third-party mediator. No mediation date has been set. While it is too early to predict the ultimate outcome of this matter, we believe the Company has meritorious defenses and intends to defend this matter vigorously. 13. Subsequent Events On October 1, 2024, the Company granted 481,312 restricted stock units to certain employees with a three-year vesting period pursuant to the Neuraxis, Inc. 2022 Omnibus Securities and Incentive Plan, including an amendment to a hiring grant that replaced 100,000 unissued common shares with 100,000 restricted stock units included herein (see Note 9). On October 15, 2024, the Company received $ 145,000 in exchange for 60,924 shares of Series B Preferred Stock. On November 9, 2024, the Company entered into a $ 5,000,000 investment agreement with a reputable life sciences fund at terms identical to the Series B Preferred Stock Shareholders, including the extension of the expiration date of the cumulative dividends from June 30, 2025 to December 31, 2026, that replaced a $ 3,200,000 reduction in committed funding from an existing investor. The transaction is expected to close mid-November. The Company has evaluated subsequent events through the filing of this Quarterly Report on Form 10-Q and determined that there have been no events that have occurred that would require adjustments to our disclosures in the condensed financial statements. 26