Neuraxis, INC
For the period ended Sep 30, 2025. Filed Nov 10, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 10, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0001641172-25-023100
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-10.
0001493152-25-021547
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 49 previous paragraphs and 49 current paragraphs.
23 unchanged; 23 reworded; 3 added; 3 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (3)
Current report
Other (Expense) Income, Net
Current report
Other expense decreased $81,250 or 78.2%, from $103,961 for the three months ended September 30, 2024, to $22,711 for the three months ended September 30, 2025, primarily due to the conversion of convertible notes into Series B Preferred Stock in 2024 which eliminated any related debt discount and interest charges, partially offset by the settlement of certain shareholder claims.
Current report
Our net loss increased $367,562, or 20.9%, from $1,755,234 for the three months ended September 30, 2024, to $2,122,796 for the three months ended September 30, 2025, due to higher selling and general and administrative expenses, partially offset by higher sales volume and the conversion of convertible notes into Series B Preferred Stock in 2024 which eliminated any related debt discount and interest charges.
Removed paragraphs (3)
Previous report
Other Income (Expense), Net
Previous report
Other income increased $738,318, or 103.9%, from $710,878 of expenses for the three months ended June 30, 2024, to $27,440 of income for the three months ended June 30, 2025, primarily due to the absence of a one-time, non-recurring 2024 settlement of certain claims relating to pre-IPO Series A Preferred Stock shareholders.
Previous report
Our net loss decreased $1,227,292, or 42.1%, from $2,917,710 for the three months ended June 30, 2024, to $1,690,418 for the three months ended June 30, 2025, due to higher sales volume, lower general and administrative expenses and the absence of a one-time, non-recurring 2024 settlement of certain claims relating to pre-IPO Series A Preferred Stock shareholders.
Reworded paragraphs (23)
Previous wording
Since our inception, we have incurred significant operating losses. Our net loss was $1,690,418 and $2,917,710 for the three months ended June 30, 2025 and 2024, respectively, and $3,969,102 and $5,038,361 for the six months ended June 30, 2025 and 2024, respectively. Although we had stockholders’ equity of $4,253,294 as of June 30, 2025, our auditors have expressed substantial doubt about our ability to continue as a going concern in their audit opinion. We expect to incur significant expenses and operating losses for the foreseeable future as we continue to pursue widespread insurance coverage of our IB-Stim device and seek FDA clearance of our device for other indications as we also fund sales and marketing efforts to expand the adoption of RED. There are a number of milestones and conditions that we must satisfy before we will be able to generate sufficient revenue to fund our operations, including FDA clearance of our IB-Stim device to treat future indications.
Current wording
Since our inception, we have incurred significant operating losses. Our net loss was $2,122,796 and $1,755,234 for the three months ended September 30, 2025 and 2024, respectively, and $6,091,898 and $6,793,596 for the nine months ended September 30, 2025 and 2024, respectively. Although we had stockholders’ equity of $2,284,941 as of September 30, 2025, our auditors have expressed substantial doubt about our ability to continue as a going concern in their audit opinion. We expect to incur significant expenses and operating losses for the foreseeable future as we continue to pursue widespread insurance coverage of our IB-Stim device and seek FDA clearance of our device for other indications as we also fund selling and marketing efforts to expand the adoption of RED. There are a number of milestones and conditions that we must satisfy before we will be able to generate sufficient revenue to fund our operations, including FDA clearance of our IB-Stim device to treat future indications.
Previous wording
Costs of goods sold consist of costs paid for the IB-Stim and RED devices to our contract manufacturers along with shipping and handling costs and expired inventory charges. Expired inventory expense is related to the FDA clearance period from the date our devices are manufactured, and if the device is not sold in such period, a reserve is recorded. Expired and other inventory charges totaled $12,174 and $12,174 for the three and six months ended June 30, 2025, respectively. There was no expired inventory for the three and six months ended June 30, 2024. We have fixed-price contracts with the manufacturers of our devices.
Current wording
Costs of goods sold consist of costs paid for the IB-Stim and RED devices to our contract manufacturers along with shipping and handling costs and expired inventory charges. Expired inventory expense is related to the FDA clearance period from the date our devices are manufactured, and if the device is not sold in such period, a reserve is recorded. Expired and other inventory charges totaled $11,598 and $2,030 for the three months ended September 30, 2025 and 2024, respectively, and $24,339 and $2,030 for the nine months ended September 30, 2025 and 2024, respectively. We have fixed-price contracts with the manufacturers of our devices.
Previous wording
Our core selling expenses primarily consist of commissions.
Current wording
Our selling expenses primarily consist of advertising, marketing and promotion of the Company’s products including salaries and related personnel costs and travel expenses. The Company reclassified $243,093 and $786,546 of General and Administrative Expenses to Selling Expenses in the Condensed Statements of Operations for the three and nine months ended September 30, 2024, respectively, to conform to current period presentation.
Previous wording
Research and development expense is attributable to our clinical trials and related efforts to have our IB-Stim and RED devices cleared by the FDA for other indications. We expect to incur future R&D expenses for other indications, such as functional nausea, post-concussion syndrome and cyclic vomiting syndrome in children.
Current wording
Research and development expenses consist primarily of clinical research studies, new product development, costs of materials and supplies used in research and development activities and salaries and related personnel costs for employees engaged in research and development activities to have our IB-Stim and RED devices cleared by the FDA for other indications. The Company reclassified $53,825 and $164,396 of General and Administrative Expenses to Research and Development Expenses in the Condensed Statements of Operations for the three and nine months ended September 30, 2024, respectively, to conform to current period presentation. We expect to incur future research and development expenses for other indications, such as post-concussion syndrome and cyclic vomiting syndrome in children.
Previous wording
General and administrative expense primarily consists of wages and benefits, professional fees, including legal, audit, insurance, investor relations, advertising, facility costs, utilities and travel costs.
Current wording
General and administrative expense primarily consists of wages and benefits, professional fees, including legal, audit, insurance, investor relations, facility costs, utilities and travel costs.
Previous wording
The following table presents our statements of operations for the three and six months ended June 30, 2025 and 2024, respectively:
Current wording
The following table presents our statements of operations for the three and nine months ended September 30, 2025 and 2024, respectively:
Previous wording
Net sales increased $282,586, or 46.2%, from $611,500 for the three months ended June 30, 2024, to $894,086 for the three months ended June 30, 2025, and increased $531,606, or 42.3%, from $1,258,135 for the six months ended June 30, 2024, to $1,789,741 for the six months ended June 30, 2025. The increases were due to volume growth from customers with full health insurance reimbursement coverage and those participating in our financial assistance programs that provide discounts to patients without insurance coverage and device sales from the Company’s launch of its RED product in 2025.
Current wording
Net sales increased $144,789, or 21.7%, from $666,625 for the three months ended September 30, 2024, to $811,414 for the three months ended September 30, 2025, and increased $676,395, or 35.1%, from $1,924,760 for the nine months ended September 30, 2024, to $2,601,155 for the nine months ended September 30, 2025. The increases were due to volume growth from (i) customers with full health insurance reimbursement coverage and those participating in our financial assistance programs that provide discounts to patients without insurance coverage and (ii) device sales from the Company’s launch of its RED product in 2025. Unit growth from the discounted financial assistance programs outpaced the full health insurance reimbursement programs.
Previous wording
Gross profit increased $209,401, or 38.9%, from $538,042 for the three months ended June 30, 2024, to $747,443 for the three months ended June 30, 2025, due to higher sales volume. Despite the increase in sales volume, the decrease in gross margin from 88.0% for the three months ended June 30, 2024, to 83.6% for the three months ended June 30, 2025, was due to higher discounting in the Company’s financial assistance programs provided to patients without health insurance coverage and expired RED inventory.
Current wording
Gross profit increased $106,352, or 18.7%, from $569,575 for the three months ended September 30, 2024, to $675,927 for the three months ended September 30, 2025, due to higher sales volume. Despite the increase in sales volume, the decrease in gross margin from 85.4% for the three months ended September 30, 2024, to 83.3% for the three months ended September 30, 2025, was due to higher discounting in the Company’s financial assistance programs provided to patients without health insurance coverage, a higher unit growth rate of the discounted financial assistance programs compared to the full health insurance reimbursement programs and expired RED inventory.
Previous wording
Gross profit increased $394,027, or 35.5%, from $1,109,596 for the six months ended June 30, 2024, to $1,503,623 for the six months ended June 30, 2025, due to higher sales volume. Despite the increase in sales volume, gross margin decreased from 88.2% for the six months ended June 30, 2024, to 84.0% for the six months ended June 30, 2025, due to higher growth of the financial assistance programs versus the full reimbursement patients, higher discounting in the Company’s financial assistance programs provided to patients without health insurance coverage and expired RED inventory.
Current wording
Gross profit increased $512,079, or 30.7%, from $1,667,811 for the nine months ended September 30, 2024, to $2,179,890 for the nine months ended September 30, 2025, due to higher sales volume. Despite the increase in sales volume, gross margin decreased from 86.7% for the nine months ended September 30, 2024, to 83.8% for the nine months ended September 30, 2025, due to higher discounting in the Company’s financial assistance programs provided to patients without health insurance coverage, a higher unit growth rate of the discounted financial assistance programs compared to the full health insurance reimbursement programs and expired RED inventory.
Previous wording
Selling expenses increased $79,979, or 128.4%, from $62,274 for the three months ended June 30, 2024, to $142,253 for the three months ended June 30, 2025, and increased $133,902, or 94.1%, from $142,304 for the six months ended June 30, 2024, to $276,206 for the six months ended June 30, 2025. The increases were due to higher sales volume and a temporary commission structure to facilitate growth and adoption in new states.
Current wording
Selling expenses increased $424,025, or 125.3%, from $338,523 for the three months ended September 30, 2024, to $762,548 for the three months ended September 30, 2025, and increased $681,434, or 67.3%, from $1,012,920 for the nine months ended September 30, 2024, to $1,694,354 for the nine months ended September 30, 2025. The increases were due to higher commissions from sales volume, a temporary commission structure to facilitate growth and adoption in new states, incremental sales and marketing headcount and increased advertising and marketing costs targeting patients and health insurance carriers as IB-Stim’s new Current Procedural Terminology (CPT) Category I code becomes effective January 1, 2026.
Previous wording
Research and development expenses increased $4,007, or 7.4%, from $54,312 for the three months ended June 30, 2024, to $58,319 for the three months ended June 30, 2025, and increased $48,130, or 80.4%, from $59,882 for the six months ended June 30, 2024 to $108,012 for the six months ended June 30, 2025. The increases were due to higher year-over-year spending on a medical research project and costs to develop the RED device.
Current wording
Research and development expenses increased $4,603, or 3.6%, from $126,247 for the three months ended September 30, 2024, to $130,850 for the three months ended September 30, 2025, and increased $52,245, or 17.7%, from $295,188 for the nine months ended September 30, 2024 to $347,433 for the nine months ended September 30, 2025. The increases were due to higher year-over-year spending on a medical research project, improved IB-Stim design features and costs to develop the RED device.
Previous wording
General and administrative expenses decreased $363,559, or 13.8%, from $2,628,288 for the three months ended June 30, 2024, to $2,264,729 for the three months ended June 30, 2025, primarily due to the absence of certain one-time, non-recurring severance, consulting and advisory costs incurred in 2024 and lower accounting, investor relations, insurance and advertising costs as new hires in 2024 have internally absorbed certain services, partially offset by third party costs incurred to enhance the Company’s internal control environment.
Current wording
General and administrative expenses increased $126,536, or 7.2%, from $1,756,078 for the three months ended September 30, 2024, to $1,882,614 for the three months ended September 30, 2025, primarily due to the introduction of annual short-term and long-term incentive plans in 2024 that were not outstanding for the full fiscal year and headcount and related costs incurred to enhance the Company’s internal control environment and financial operations, partially offset by the absence of certain one-time, non-recurring severance, consulting and advisory costs incurred in 2024.
Previous wording
General and administrative expenses increased $185,998, or 3.8%, from $4,946,362 for the six months ended June 30, 2024, to $5,132,360 for the six months ended June 30, 2025, primarily due to a one-time, non-recurring charge to settle a lawsuit, third party costs incurred to enhance the Company’s internal control environment and the introduction of annual short-term and long-term incentive plans in 2024 that were not outstanding for the full fiscal year, partially offset by the absence of certain one-time, non-recurring severance, hiring, consulting and advisory costs incurred in 2024 and lower legal, accounting, investor relations and insurance costs as new hires in 2024 have internally absorbed certain services.
Current wording
General and administrative expenses increased $201,215, or 3.3%, from $6,049,928 for the nine months ended September 30, 2024, to $6,251,143 for the nine months ended September 30, 2025, primarily due to a one-time, non-recurring charge to settle a lawsuit, headcount and related costs incurred to enhance the Company’s internal control environment and the introduction of annual short-term and long-term incentive plans in 2024 that were not outstanding for the full fiscal year, partially offset by the absence of certain one-time, non-recurring severance, hiring, consulting and advisory costs incurred in 2024 and lower legal, accounting, investor relations and insurance costs as new hires in 2024 have internally absorbed certain services.
Previous wording
Our operating loss decreased $488,974, or 22.2%, from $2,206,832 for the three months ended June 30, 2024, to $1,717,858 for the three months ended June 30, 2025, primarily due to higher sales volume and lower general and administrative expenses, partially offset by a lower gross margin and higher selling costs that are a function of revenue.
Current wording
Our operating loss increased $448,812, or 27.2%, from $1,651,273 for the three months ended September 30, 2024, to $2,100,085 for the three months ended September 30, 2025, primarily due to higher selling and general and administrative expenses, partially offset by higher sales volume.
Previous wording
Our operating loss decreased $25,997, or 0.6%, from $4,038,952 for the six months ended June 30, 2024, to $4,012,955 for the six months ended June 30, 2025, primarily due to higher sales volume, partially offset by a lower gross margin, higher general and administrative costs primarily due to a one-time, non-recurring settlement of a lawsuit, higher research and development costs and higher selling costs that are a function of revenue.
Current wording
Our operating loss increased $422,815, or 7.4%, from $5,690,225 for the nine months ended September 30, 2024, to $6,113,040 for the nine months ended September 30, 2025, primarily due to higher selling and general and administrative expenses including a one-time non-recurring settlement of a lawsuit, partially offset by higher sales volume.
Previous wording
Other income increased $1,043,262, or 104.4% from $999,409 of expense for the six months ended June 30, 2024, to $43,853 of income for the six months ended June 30, 2025, primarily due the absence of one-time, non-recurring 2024 settlements relating to a 2023 convertible note dispute and certain pre-IPO Series A Preferred Stock shareholder claims.
Current wording
Other expense decreased $1,124,513, or 101.9% from $1,103,371 of expense for the nine months ended September 30, 2024, to $21,142 of income for the nine months ended September 30, 2025, primarily due to the absence of one-time, non-recurring 2024 settlements relating to a 2023 convertible note dispute and certain pre-IPO Series A Preferred Stock shareholder claims and the conversion of convertible notes into Series B Preferred Stock in 2024 which eliminated any related debt discount and interest charges.
Previous wording
Our net loss decreased $1,069,259 from $5,038,361 for the six months ended June 30, 2024, to $3,969,102 for the six months ended June 30, 2025, primarily due to higher sales volume and the absence of one-time, non-recurring 2024 settlements relating to a 2023 convertible note dispute and certain pre-IPO Series A Preferred Stock shareholder claims, partially offset by the one-time, non-recurring settlement of a lawsuit in 2025.
Current wording
Our net loss decreased $701,698, or 10.3%, from $6,793,596 for the nine months ended September 30, 2024, to $6,091,898 for the nine months ended September 30, 2025, primarily due to higher sales volume and the absence of one-time, non-recurring 2024 settlements relating to a 2023 convertible note dispute and certain pre-IPO Series A Preferred Stock shareholder claims, partially offset by higher selling expenses and the one-time, non-recurring settlement of a lawsuit in 2025.
Previous wording
We had cash on hand of $5,988,456 and $3,696,870 as of June 30, 2025, and December 31, 2024, respectively. We maintained a working capital surplus of $4,271,446 and $1,832,858 as of June 30, 2025, and December 31, 2024, respectively. The increase in working capital was primarily due to proceeds from the issuance of common stock and the exercise of common stock warrants during the six months ended June 30, 2025.
Current wording
We had cash on hand of $4,377,109 and $3,696,870 as of September 30, 2025, and December 31, 2024, respectively. We maintained a working capital surplus of $1,840,599 and $1,832,858 as of September 30, 2025, and December 31, 2024, respectively. The increase in working capital was primarily due to proceeds from the issuance of common stock and the exercise of common stock warrants partially offset by liabilities incurred to settle a lawsuit and purchase the NSS-2 Bridge trademark during the nine months ended September 30, 2025.
Previous wording
We have incurred losses since inception and have funded our operations primarily with a combination of sales, debt, and the sale of capital stock. As of June 30, 2025, we had stockholders’ equity of $4,253,294 and short-term borrowings of $121,433.
Current wording
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, 2025, we had stockholders’ equity of $2,284,941 and short-term borrowings of $195,658.
Previous wording
The following table summarizes our cash flow from operating, investing and financing activities for the six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes our cash flow from operating, investing and financing activities for the nine months ended September 30, 2025 and 2024:
Previous wording
Operating Activities – Net cash used in operating activities increased $123,850, or 4.2%, for the six months ended June 30, 2025, compared to the six months ended June 30, 2024, primarily due to higher inventory purchases to support sales growth and the 2025 payment of the 2024 short-term incentive program, partially offset by increased cash collections.
Current wording
Operating Activities – Net cash used in operating activities increased $158,587, or 3.7%, for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024, primarily due to higher inventory purchases to support current sales growth and readiness for the January 1, 2026 effective date for the IB-Stim Category I CPT code and the 2025 payment of the 2024 short-term incentive program, partially offset by increased cash collections.
Previous wording
Investing Activities – Net cash used in investing activities increased $1,880, or 8.0%, for the six months ended June 30, 2025, compared to the six months ended June 30, 2024, due to capital expenditures to manufacture the RED device.
Current wording
Investing Activities – Net cash used in investing activities decreased $2,488, or 9.0%, for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024, due to lower office equipment purchases partially offset by expenditures to manufacture the RED device.
Previous wording
Financing Activities – Net cash provided by financing activities increased $730,602, or 15.7%, for the six months ended June 30, 2025, compared to the six months ended June 30, 2024, primarily due to proceeds received from the issuance of common stock and the exercise of common stock warrants in 2025 compared to the issuance of convertible notes in 2024.
Current wording
Financing Activities – Net cash provided by financing activities increased $654,013, or 14.4%, for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024, primarily due to proceeds received from the issuance of common stock and the exercise of common stock warrants in 2025 compared to the issuance of convertible notes in 2024.