nuro-20240930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ____ to ____

Commission File Number 001-33351

_________________________________________________

NEUROMETRIX, INC.

(Exact name of registrant as specified in its charter)


Delaware			04-3308180
(State or other jurisdiction of			(I.R.S. Employer Identification No.)
incorporation or organization)

4B Gill Street Woburn, Massachusetts			01801
(Address of principal executive offices)			(Zip Code)

(781) 890-9989

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of exchange on which registered
Common Stock, $0.0001 par value per share	NURO	The Nasdaq Stock Market LLC
Preferred Stock Purchase Rights

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes x No ¨

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yes x No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐ No x

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 2,042,689 shares of common stock, par value $0.0001 per share, were outstanding as of November 4, 2024.

NeuroMetrix, Inc.

Form 10-Q

Quarterly Period Ended September 30, 2024

TABLE OF CONTENTS


PART I – FINANCIAL INFORMATION

Item 1.	Financial Statements:

	Balance Sheets as of September 30, 2024 (unaudited) and December 31, 2023	1

	Statements of Operations (unaudited) for the Quarters and Nine Months Ended September 30, 2024 and 2023	2

	Statements of Comprehensive Loss (unaudited) for the Quarters Ended September 30, 2024 and 2023	2

	Statements of Changes in Stockholders' Equity (unaudited) for the Quarters and Nine Months Ended September 30, 2024 and 2023	3

	Statements of Cash Flows (unaudited) for the Nine Months Ended September 30, 2024 and 2023	4

	Notes to Unaudited Financial Statements	5

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	12

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	19

Item 4.	Controls and Procedures	20

PART II – OTHER INFORMATION

Item 1.	Legal Proceedings	21

Item 1A.	Risk Factors	21

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	21

Item 3.	Defaults Upon Senior Securities	21

Item 4.	Mine Safety Disclosures	21

Item 5.	Other Information	21

Item 6.	Exhibits	22

Signatures		23

All share amounts in the Quarterly Report on Form 10-Q have been adjusted to reflect a 1-for-8 reverse stock split that was effected on November 21, 2023.

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

NeuroMetrix, Inc.

Balance Sheets


	September 30, 2024		December 31, 2023
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	921,520	$	1,731,946

Available-for-sale securities	13,913,080		16,265,205
Accounts receivable, net	149,092		518,824
Inventories	1,430,122		1,559,428

Prepaid expenses and other current assets	381,876		779,039
Total current assets	16,795,690		20,854,442

Fixed assets, net	219,106		293,449
Right of use asset	147,824		250,150
Other long-term assets	26,400		26,400
Total assets	$	17,189,020	$	21,424,441

Liabilities and Stockholders’ Equity
Current liabilities:

Accounts payable	$	347,641	$	215,509

Accrued expenses and compensation	719,609		876,739

Lease obligation, current	142,621		148,391
Total current liabilities	1,209,871		1,240,639

Lease obligation, net of current portion	—		92,485
Total liabilities	1,209,871		1,333,124

Commitments and contingencies

Stockholders’ equity:
Preferred stock	—		—
Convertible preferred stock	1		1
Common stock, $0.0001 par value; 25,000,000 shares authorized at September 30, 2024 and December 31, 2023; 2,033,306 and 1,524,939 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	203		152
Additional paid-in capital	232,030,177		229,960,346
Accumulated other comprehensive income	83,853		240,171
Accumulated deficit	(216,135,085)		(210,109,353)
Total stockholders’ equity	15,979,149		20,091,317
Total liabilities and stockholders’ equity	$	17,189,020	$	21,424,441

The accompanying notes are an integral part of these interim financial statements.

NeuroMetrix, Inc.

Statements of Operations

(Unaudited)


	Quarters Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023

Revenues	$	587,314	$	1,203,164	$	2,450,018	$	4,583,679

Cost of revenues	275,357		421,382		1,129,125		1,484,240

Gross profit	311,957		781,782		1,320,893		3,099,439

Operating expenses:
Research and development	299,739		592,654		1,510,223		2,045,588
Sales and marketing	441,171		943,795		1,937,914		2,504,630
General and administrative	1,313,095		1,206,231		4,697,450		3,843,643

Total operating expenses	2,054,005		2,742,680		8,145,587		8,393,861

Loss from operations	(1,742,048)		(1,960,898)		(6,824,694)		(5,294,422)

Other income:
Interest income	8,412		25,378		40,579		247,699
Other income	225,410		166,783		758,383		166,783

Total other income	233,822		192,161		798,962		414,482

Net loss	$	(1,508,226)	$	(1,768,737)	$	(6,025,732)	$	(4,879,940)








Net loss per common share applicable to common stockholders, basic and diluted	$	(0.75)	$	(1.66)	$	(3.10)	$	(4.86)


Weighted average number of common shares outstanding, basic and diluted	2,023,280		1,065,003		1,945,995		1,004,339

Statements of Comprehensive Loss

(Unaudited)


	Quarters Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023

Net loss	$	(1,508,226)	$	(1,768,737)	$	(6,025,732)	$	(4,879,940)

Other comprehensive income:

Unrealized gain on available-for-sale securities, net	197,092		204,931		602,065		373,652
Reclassification of realized gain on available-for-sale securities to other income	$	(225,410)	$	(166,783)	$	(758,383)	$	(166,783)

Comprehensive loss	$	(1,536,544)	$	(1,730,589)	$	(6,182,050)	$	(4,673,071)

The accompanying notes are an integral part of these interim financial statements.

NeuroMetrix, Inc.

Statements of Changes in Stockholders' Equity

(Unaudited)


	Series B Convertible Preferred Stock			Common Stock			Additional Paid-In Capital		Accumulated Other Comprehensive Income		Accumulated Deficit		Total
	Number of Shares	Amount		Number of Shares	Amount
Balance at December 31, 2023	200.00	$	1	1,518,717	$	152	$	229,960,346	$	240,171	$	(210,109,353)	$	20,091,317
Stock-based compensation expense	—	—		—	$	—	216,164		—		—		216,164
Issuance of common stock under at the market offering	—	—		458,380	$	46	1,471,053		—		—		1,471,099
Vesting of restricted stock under equity plan	—	—		6,699	$	1	(1)		—		—		—
Other comprehensive income	—	—		—	$	—	—		7,006		—		7,006

Net loss	—	—		—	$	—	—		—		(3,029,574)		(3,029,574)
Balance at March 31, 2024	200.00	1		1,983,796	199		231,647,562		247,177		(213,138,927)		18,756,012
Stock-based compensation expense	—	—		—	—		176,148		—		—		176,148
Issuance of common stock under employee stock purchase plan	—	—		850	—		2,601		—		—		2,601
Vesting of restricted stock under equity plan	—	—		29,453	3		(3)		—		—		—
Other comprehensive income	—	—		—	—		—		(135,006)		—		(135,006)

Net loss	—	—		—	—		—		—		(1,487,932)		(1,487,932)
Balance at June 30, 2024	200	$	1	2,014,099	$	202	$	231,826,308	$	112,171	$	(214,626,859)	$	17,311,823
Stock-based compensation expense	—	—		—			203,870		—		—		203,870
Vesting of restricted stock under equity plan	—	—		17,610	1		(1)		—		—		—
Other comprehensive income	—	—		—	—		—		(28,318)		—		(28,318)

Net loss	—	—		—	—		—		—		(1,508,226)		(1,508,226)
Balance at September 30, 2024	200	1		2,031,709	203		232,030,177		83,853		(216,135,085)		15,979,149

	Series B Convertible Preferred Stock			Common Stock			Additional Paid-In Capital		Accumulated Other Comprehensive Income		Accumulated Deficit		Total
	Number of Shares	Amount		Number of Shares	Amount
Balance at December 31, 2022	200.00	$	1	959,460	$	96	$	226,935,456	$	—	$	(203,579,866)	$	23,355,687
Stock-based compensation expense	—	—		—	—		165,361		—		—		165,361
Vesting of restricted stock under equity plan	—	—		2,439	—		—		—		—		—
Other comprehensive income	—	—		—	—		—		65,874		—		65,874
Net loss	—	—		—	—		—		—		(1,574,174)		(1,574,174)
Balance at March 31, 2023	200.00	1		961,899	96		227,100,817		65,874		(205,154,040)		22,012,748
Stock-based compensation	—	—		—	—		132,745		—		—		132,745
Issuance of common stock under at the market offering	—	—		90,661	9		691,396		—		—		691,405
Issuance common stock under employee stock purchase plan	—	—		1,316	—		8,713		—		—		8,713
Vesting of restricted stock under equity plan	—	—		9,015	1		(1)		—		—		—
Other comprehensive income	—	—		—	—		—		102,847		—		102,847
Net loss	—	—		—	—		—		—		(1,537,029)		(1,537,029)
Balance at June 30, 2023	200	$	1	1,062,891	$	106	$	227,933,670	$	168,721	$	(206,691,069)	$	21,411,429
Stock-based compensation	—	—		—	—		221,268		—		—		221,268
Issuance of common stock under at the market offering	—	—		184	—		1,426		—		—		1,426
Vesting of restricted stock under equity plan	—	—		2,820	—		—		—		—		—
Other comprehensive income	—	—		—	—		—		38,148		—		38,148

Net loss	—	—		—	—		—		—		(1,768,737)		(1,768,737)
Balance at September 30, 2023	200	$	1	1,065,895	$	106	$	228,156,364	$	206,869	$	(208,459,806)	$	19,903,534

The accompanying notes are an integral part of these interim financial statements.

NeuroMetrix, Inc.

Statements of Cash Flows

(Unaudited)


	Nine Months Ended September 30,
	2024		2023
Cash flows from operating activities:
Net loss	$	(6,025,732)	$	(4,879,940)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	74,343		30,957
Amortization of right-of-use assets, operating lease	102,326		58,087
Stock-based compensation	596,182		519,374

Inventory reserve charged to cost of revenue	74,209		63,420

Amortization of premiums and discounts on held-to-maturity securities	—		(135,293)
Realized gain on available-for-sale securities	(758,383)		(166,783)
Changes in operating assets and liabilities:
Accounts receivable	369,732		32,390
Inventories	55,097		(115,042)

Prepaid expenses and other current and long-term assets	363,183		(200,118)
Accounts payable	132,132		(142,608)
Accrued expenses and compensation	(157,130)		356,562
Operating lease liability	(64,275)		(55,373)
Net cash used in operating activities	(5,238,316)		(4,634,367)

Cash flows from investing activities:

Purchases of available-for-sale securities	(29,045,810)		(22,898,470)
Proceeds from maturities of available-for-sale securities	32,000,000		7,095,000
Proceeds from maturities of held-to-maturity securities	—		17,000,000
Purchases of fixed assets	—		(138,176)
Net cash provided by (used in) investing activities	2,954,190		1,058,354

Cash flows from financing activities:
Net proceeds from issuance of stock	1,473,700		701,546


Net cash provided by financing activities	1,473,700		701,546

Net decrease in cash and cash equivalents	(810,426)		(2,874,467)
Cash and cash equivalents, beginning of period	1,731,946		4,335,020
Cash and cash equivalents, end of period	$	921,520	$	1,460,553

The accompanying notes are an integral part of these interim financial statements.

NeuroMetrix, Inc.

Notes to Unaudited Financial Statements

September 30, 2024

1.Business and Basis of Presentation

Our Business-An Overview

NeuroMetrix, Inc. (the "Company" or "NeuroMetrix") develops and commercializes health care products that utilize non-invasive neurostimulation. Revenues are derived from the sale of medical devices and after-market consumable products and accessories. The Company’s products are sold in the United States and select overseas markets. They are cleared by the U.S. Food and Drug Administration ("FDA") and regulators in foreign jurisdictions where appropriate. The Company has two primary products. DPNCheck® is a point-of-care test for diabetic peripheral neuropathy, which is the most common long-term complication of Type 2 diabetes. Quell is an app-enabled, wearable device for lower extremity chronic pain and for the symptoms of fibromyalgia.

The Company held cash, cash equivalents and investment grade securities totaling $14.8 million as of September 30, 2024. The Company believes that its present balance of cash resources and securities coupled with cash inflows from product sales will enable the Company to fund its operations for at least the next twelve months from the date of issuance of the financial statements. Actual cash requirements could differ from management's projections for many reasons, including changes the Company may make to its business strategy, commercial challenges, regulatory developments, changes to research and development programs, supply chain issues, staffing challenges and other items affecting the Company's projected uses of cash.

During February 2024, the Company announced that it would undertake a review of its strategic options to maximize shareholder value. These options include changes in marketing strategies, the acquisition of new assets, potential sale of Company assets, and a merger or other strategic transaction. This review process remains ongoing. A timetable for completion of this process has not been established, and even if certain strategic alternatives may be available, the Company cannot provide any assurance that the strategic alternatives review process will result in the successful realization of any particular alternative, transaction or value. Accordingly, the unaudited financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.

Unaudited Interim Financial Statements

The accompanying unaudited balance sheet as of September 30, 2024, unaudited statements of operations, statements of comprehensive loss, changes in stockholders' equity and cash flows for the quarters ended September 30, 2024 and 2023 have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. The accompanying balance sheet as of December 31, 2023 has been derived from the audited balance sheet as of December 31, 2023 included in the Company's Form 10-K referenced below and does not include all disclosures required by U.S. GAAP. In the opinion of management, the financial statements include all normal and recurring adjustments considered necessary for a fair presentation of the Company’s financial position and operating results. Operating results for the nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024 or any other period. These financial statements and notes should be read in conjunction with the financial statements for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (the "SEC"), on March 1, 2024 (File No. 001-33351).

Prior period reclassification

Certain items in the Statements of Cash Flows from the prior year were reclassified to conform with the current presentation.

Revenues

Revenues include product sales, net of estimated returns. Revenue is measured as the amount of consideration the Company expects to receive in exchange for product transferred. Revenue is recognized at the point in time when contractual performance obligations have been satisfied and control of the product has been transferred to the customer. The Company has a single product delivery performance obligation. Accrued product returns using the most likely amount method are estimated based on historical data and evaluation of current information and variable consideration is not constrained. Revenue from product sales that occur via an online pharmacy agent are recognized on a gross basis and the related fulfillment fees are expensed within cost of revenues.

Accounts receivable are recorded in the amount the Company expects to collect, net of the allowance for credit losses. The allowance for credit losses is the Company’s best estimate of the amount of probable credit losses based on customer past payment history, product usage activity, and recent communications with the customer. Individual customer balances which are over 90 days past due are reviewed individually for collectability and written-off when recovery is not probable. The Company does not have any off-balance sheet credit exposure related to its customers. Allowance for credit losses was $25,000 as of September 30, 2024 and December 31, 2023.

Two customers accounted for 28% of total revenues in the quarter ended September 30, 2024 and two different customers accounted for 28% of total revenues in the quarter ended September 30, 2023. One customer accounted for 10% of total revenues for the nine months ended September 30, 2024 and two customers accounted for 26% of total revenues in the nine months ended September 30, 2023. Four customers accounted for 74% and three customers accounted for 74% of accounts receivable as of September 30, 2024 and December 31, 2023, respectively.

Cash and Cash Equivalents

Cash and cash equivalents include bank demand deposits and money market funds that invest primarily in U.S. government securities.

Securities

The Company invests in highly liquid, marketable debt securities with high credit ratings and typically with maturities of two years or less. Individual securities are designated by the Company as either "held-to-maturity" ("HTM") or “available-for-sale” ("AFS") at the point of investment. Securities classified as short-term have maturities of less than one year. As of September 30, 2024, all marketable securities held by the Company are classified as AFS and had remaining contractual maturities of one year or less.

HTM securities are valued on an amortized cost basis and reviewed to determine if an allowance for credit losses should be recorded in the statements of operations. AFS securities are valued at fair value. Unrealized gains and losses on AFS securities are included as a component of accumulated other comprehensive income in the balance sheets and statements of stockholders’ equity and a component of total comprehensive loss in the statements of comprehensive loss. An AFS security may be impaired if its fair value is less than amortized cost. Unrealized losses are evaluated to determine if the impairment is credit-related or non-credit-related. Credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings, and a non-credit-related impairment is recognized in other comprehensive loss. For certain types of securities, such as U.S. Treasuries, the Company generally expects zero credit losses. No allowance for credit losses was recorded on its securities portfolio as of September 30, 2024 or December 31, 2023.

Fair Value

The Company follows the provisions of Financial Accounting Standards Board (the "FASB") Accounting Standards Codification ("ASC") Topic 820-10, Fair Value Measurements and Disclosures ("ASC 820-10"), which defines fair value, establishes a framework for measuring fair value in GAAP and requires certain disclosures about fair value measurements. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.

As a basis for considering such assumptions, ASC 820-10 established a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value as follows: Level 1 observable inputs such as quoted prices in active markets; Level 2 inputs, other than quoted prices in active markets, that are observable either directly or indirectly; and Level 3 unobservable inputs for which there are little or no market data, which require the Company to develop its own assumptions. The hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value (See Note 5).

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make significant estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during reporting periods. Actual results could differ from those estimates.

Recent Accounting Pronouncements

Accounting Standards Updates ("ASUs") issued by the FASB are evaluated for their applicability. ASUs not included in the disclosures in this report were assessed and determined to be either not applicable or not expected to have a material impact on our financial statements.

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires enhanced disclosures on both an annual and interim basis about significant segment expenses, including for companies with only one reportable segment. This ASU is effective on a retrospective basis for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact of the adoption of this standard on the Company’s Financial Statements and disclosures.

In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosures of specific categories in the rate reconciliation, additional information for reconciling items that meet a quantitative threshold and income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of this standard on the Company’s Financial Statements and disclosures.

2. Net Loss Per Common Share

Basic and diluted net loss per common share were as follows:


	Quarters Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Net loss applicable to common stockholders	$	(1,508,226)	$	(1,768,737)	$	(6,025,732)	$	(4,879,940)



Weighted average number of common shares outstanding, basic and diluted	2,023,280		1,065,003		1,945,995		1,004,339

Net loss per common share applicable to common stockholders, basic and diluted	$	(0.75)	$	(1.66)	$	(3.10)	$	(4.86)

Shares underlying the following potentially dilutive weighted average number of common stock equivalents were excluded from the calculation of diluted net loss per common share because their effect was anti-dilutive for each of the periods presented:


	September 30,
		2024	2023
Options		62,898	65,037
Unvested restricted stock awards		1,597	7,662
Unvested restricted stock units		92,991	37,706
Convertible preferred stock		8	8
Total		157,494	110,413

3. Securities

The Company's marketable debt securities are classified as either HTM or AFS pursuant to ASC 320 - Investments - Debt Securities. HTM securities are valued at amortized cost. The following table summarizes the valuations and unrealized gains and losses of AFS securities which are recorded at estimated fair value as of September 30, 2024 and December 31, 2023. The Company held no HTM securities as of September 30, 2024 and December 31, 2023.


	September 30, 2024
			Gross Unrealized
Available-for-sale securities	Cost		Gains		Losses		Credit Losses		Estimated Fair Value
U.S. government bonds	$	13,829,227	$	84,435	$	(582)	$	—	$	13,913,080


	December 31, 2023
			Gross Unrealized
Available-for-sale securities	Cost		Gains		Losses		Credit Losses		Estimated Fair Value
U.S. government bonds	$	4,412,935	$	5,665	$	—	$	—	$	4,418,600

Commercial paper	11,612,099		234,506		—		—		$	11,846,605
Total	$	16,025,034	$	240,171	$	—	$	—	$	16,265,205

The Company evaluates all HTM and AFS securities for impairment at each reporting period. It determined that changes in the fair value of its securities at September 30, 2024 resulted primarily from interest rate fluctuations subsequent to the purchase date of the securities. There was no deterioration in the credit worthiness of the issuers and no credit losses were recorded as of September 30, 2024.

4. Fair Value Measurements

The following tables set forth the Company’s financial instruments that were measured at fair value:


	September 30, 2024
	Total		Level 1		Level 2		Level 3
Assets:
Money market funds	$	666,939	$	666,939	$	—	$	—
U.S. government bonds	13,913,080		13,913,080		—		—

Total	$	14,580,019	$	14,580,019	$	—	$	—


	December 31, 2023
	Total		Level 1		Level 2		Level 3
Assets:
Money market funds	$	1,284,290	$	1,284,290	$	—	$	—
U.S. government bonds	4,418,600		4,418,600		—		—
Commercial paper	11,846,605		—		11,846,605		—
Total	$	17,549,495	$	5,702,890	$	11,846,605	$	—

The Company's accounts receivable, accounts payable, and accrued expenses are valued at cost which approximates fair value.

5. Inventories

Inventories consist of the following:


	September 30, 2024		December 31, 2023
Purchased components	$	1,130,180	$	1,151,381

Finished goods	299,943		408,047
	$	1,430,122	$	1,559,428

The Company recorded a charge of $74,209 in the nine months ended September 30, 2024 to write down the value of its discontinued ADVANCE inventory within cost of revenues on the Company's statements of operations. The Company also recorded a charge of $63,420 in the nine months ended September 30, 2023 to reduce the carrying value of inventory to net realizable value.

6. Accrued Expenses and Compensation

Accrued expenses and compensation consist of the following:


	September 30, 2024		December 31, 2023
Professional services	$	376,840	$	298,534
Compensation	99,312		346,245
Severance	54,000		—
Clinical	39,782		39,000
Warranty	8,000		9,400

Sales tax	130,308		141,672
Other	11,367		41,888

	$	719,609	$	876,739

During the nine months ended September 30, 2024, the Company recorded severance costs of approximately $580,000 of which approximately $54,000 remained unpaid as of September 30, 2024. See Note 10 - Employee Headcount Reduction.

7. Operating Leases

The Company's lease on its Woburn, Massachusetts corporate office and manufacturing facilities extends through mid-September 2025 at a monthly base rent of $13,846 and with a 5-year extension option.

Future minimum lease payments under this non-cancellable operating lease as of September 30, 2024 are as follows:







2024	$	41,446
2025	117,431
Total minimum lease payments	$	158,877

Interest, based on a 15% discount rate	$	16,256
Lease obligation, current portion	142,621

	$	158,877

Total recorded rent expense was $50,377 and $49,232, for the quarters ended September 30, 2024 and 2023, respectively. Total recorded rent expense was $151,132 and $147,696 for the nine month periods ended September 30, 2024 and 2023, respectively. The Company records rent expense on its facility lease on a straight-line basis over the lease term. The remaining operating lease term was 11.5 months as of September 30, 2024.

8. Stockholders’ Equity

Preferred stock and convertible preferred stock consist of the following:


	September 30, 2024		December 31, 2023
Preferred stock, $0.001 par value; 5,000,000 shares authorized at September 30, 2024 and December 31, 2023; no shares issued and outstanding at September 30, 2024 and December 31, 2023	$	—	$	—
Series B convertible preferred stock, $0.001 par value; 147,000 shares designated at September 30, 2024 and December 31, 2023; 200 shares issued and outstanding at September 30, 2024 and December 31, 2023	$	1	$	1

2024 equity activity

In the first quarter of 2024, the Company issued 458,380 shares of its common stock, under its at-the-market ("ATM") program and realized net proceeds of $1,471,099. As of April 18, 2024, the Company terminated its ATM program.

In March 2024, 1,015 unvested restricted stock awards and 5,912 unvested restricted stock units were forfeited due to the employee reduction described in Note 10.

In June 2024, the Company issued 850 shares of fully vested common stock with a value of $2,601 pursuant to the Company's Employee Stock Purchase Plan.

In the quarter ended June 30, 2024, the Company issued 91,577 restricted stock units under its 2022 Equity Incentive Plan with a value of $376,027.

As of September 30, 2024, the Company had outstanding 1,597 unvested restricted stock awards and 92,991 unvested restricted stock units. At December 31, 2023 the Company had outstanding 6,222 unvested restricted stock awards and 60,492 unvested restricted stock units.

2023 equity activity

In May 2023, the Company issued 1,563 restricted stock units under its 2022 Equity Incentive Plan with a value of $12,625.

In June 2023, the Company issued 90,661 shares of its common stock under its ATM program and realized net proceeds of $691,405. It also issued 1,316 shares of fully vested common stock with a value of $8,715 pursuant to the Company's Employee Stock Purchase Plan.

In July 2023, the Company issued 1,470 shares of its common stock, under ATM program for net proceeds of $1,426 and issued 24,500 restricted stock units under its 2004 Stock Option Plan with a value of $22,883.

In August 2023, the Company issued 172,660 restricted stock units with a value of $240,000 as long term incentives to its directors under its 2022 Equity Incentive Plan.

9. Employee Headcount Reduction

The Company incurred severance charges related to a reduction of 10 full time employees in the first quarter of 2024. This reduction was implemented in order to better align staffing with work responsibilities and to reduce operating expenses. Total severance related charges of approximately $580,000 were recorded in the quarter ended March 31, 2024 and cash payments of approximately $25,000 were made at that time. During the quarter ended June 30, 2024 and September 30, 2024, additional severance payments of approximately $334,000 and $167,000, respectively, were made and the remaining accrued severance obligation was approximately $54,000 which will be paid during the remainder of 2024 in accordance with employee contractual agreements.

The following table sets forth the quarterly activity in accrued severance.


	Nine months ended September 30, 2024
Severance
Beginning balance	$	—
Additions	580,427
Amounts paid out	(25,427)
Balance, March 31, 2024	555,000
Amounts paid out	(334,000)
Balance, June 30, 2024	221,000
Amounts paid out	(167,000)
Balance, September 30, 2024	$	54,000

Within the Company's Statements of Operations for the nine months ended September 30, 2024, total severance charges of $580,427 were recorded in the first quarter as follows: $310,200 within research and development, $234,527 within sales and marketing, $4,200 within general and administrative and $31,500 within cost of revenues.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion of our financial condition and results of operations in conjunction with our financial statements and the accompanying notes to those financial statements included elsewhere in this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements that involve risks and uncertainties. For a description of factors that may cause our actual results to differ materially from those anticipated in these forward-looking statements, please refer to the below section of this Quarterly Report on Form 10-Q titled “Cautionary Note Regarding Forward-Looking Statements.” Unless the context otherwise requires, all references to “we”, “us”, the “Company”, or “NeuroMetrix” in this Quarterly Report on Form 10-Q refer to NeuroMetrix, Inc.

Business Overview

NeuroMetrix is a commercial stage neurotechnology company based in Woburn, Massachusetts. The Company’s mission is to improve individual and population health through innovative medical devices and technology solutions for pain syndromes and neurological disorders. Our core expertise in biomedical engineering has been refined over two decades of designing, building and marketing medical devices that stimulate nerves and analyze nerve response for diagnostic and therapeutic purposes. We are fully integrated with in-house capabilities spanning research and development, manufacturing, regulatory affairs and compliance, sales and marketing, product fulfillment and customer support. We hold extensive, proprietary intellectual property.

NeuroMetrix created the market for point-of-care nerve testing and introduced sophisticated wearable technology for chronic pain syndromes. Nearly five million patients have been served with our products. Revenue is derived from the sale of medical devices, after-market consumable products and accessories in the United States and select overseas markets. Products

are authorized by the U.S. Food and Drug Administration ("FDA") and regulators in foreign jurisdictions where appropriate. We have two principal product categories:

•Therapeutic technology – wearable neuromodulation for chronic pain syndromes

•Diagnostic technology - point-of-care peripheral neuropathy assessment

Chronic pain is a significant public health problem. It is defined by the National Institutes of Health (the "NIH") as pain lasting more than 12 weeks. This contrasts with acute pain which is a normal bodily response to injury or trauma. Chronic pain conditions include low back pain, arthritis, fibromyalgia, neuropathic pain, and cancer pain, among many others. Chronic pain

may be triggered by an injury or there may be an ongoing cause such as disease or illness. There may also be no clear cause. Chronic pain can also lead to other health problems including fatigue, sleep disturbance and mood changes, which cause difficulty in carrying out important activities and contribute to disability and despair. In general, chronic pain cannot be cured. Treatment of chronic pain is focused on reducing pain and improving function. The goal is effective pain management.

Chronic pain affects nearly 100 million adults in the United States and more than 1.5 billion people worldwide. The estimated incremental impact of chronic pain on health care costs in the United States is over $250 billion per year, and lost productivity is estimated to exceed $300 billion per year. The most common approach to chronic pain management is pain medication. This includes over-the-counter internal and external analgesics as well as prescription pain medications, both non-opioid and opioids. The approach to treatment is individualized, drug combinations may be employed, and the results are often inadequate. Side effects, including the potential for addiction, are substantial. Reflecting the complexity of chronic pain and the difficulty in treating it, we believe that inadequate relief leads 25% to 50% of pain sufferers to seek alternatives to prescription pain medications. These alternatives include nutraceuticals, acupuncture, chiropractic care, non-prescription analgesics, electrical stimulators, braces, sleeves, pads and other items. In total, these pain relief products and services account for approximately $20 billion in annual out-of-pocket spending in the United States.

Nerve stimulation is a long-established category of treatment for chronic pain. This treatment approach is available through implantable devices which have both surgical and ongoing risks, such as migration of the implanted nerve stimulation leads. Non-invasive approaches involving transcutaneous electrical nerve stimulation ("TENS") have achieved limited efficacy in practice due to power limitations, inadequate dosing and low patient adherence. We believe that our Quell wearable technology for chronic pain is designed to address many of the limitations of traditional TENS.

Peripheral neuropathies, or polyneuropathies, are diseases of the peripheral nerves. They affect about 10% of adults in the United States, with the prevalence rising to over 30% among individuals 65 years and older. Peripheral neuropathies are associated with loss of sensation, pain, increased risk of falling, weakness, and other complications. People with peripheral neuropathies have a diminished quality of life, poor overall health and higher mortality. The most common specific cause of peripheral neuropathies, accounting for about one-third of cases, is diabetes. Diabetes is a worldwide epidemic with an estimated affected population of over 400 million people. Within the United States there are over 30 million people with diabetes and another 80 million with pre-diabetes. The annual direct cost of treating diabetes in the United States exceeds $100 billion. Although there are dangerous acute manifestations of diabetes, the primary burden of the disease is in its long-term complications, which include cardiovascular disease, nerve disease and resulting conditions such as foot ulcers which may require amputation, eye disease leading to blindness, and kidney failure. The most common long-term complication of diabetes, affecting over 50% of the diabetic population, is peripheral neuropathy. Diabetic peripheral neuropathy ("DPN") is the primary trigger for diabetic foot ulcers which may progress to the point of requiring amputation. People with diabetes have a 15 to 25% lifetime risk of foot ulcers and approximately 15% of foot ulcers lead to amputation. Foot ulcers are the most expensive complication of diabetes with a typical cost of $5,000 to $50,000 per episode. In addition, between 16% and 26% of people with diabetes suffer from chronic pain in their feet and lower legs.

Early detection of peripheral neuropathies, such as DPN, is important because there are no treatment options once the nerves have degenerated. Currently available diagnostic methods for peripheral neuropathies range from a simple monofilament test for lack of sensory perception in the feet to a nerve conduction study performed by a specialist. Our DPNCheck nerve conduction technology provides a rapid, low cost, quantitative test for peripheral neuropathies, including DPN. It addresses an important medical need and is particularly effective in screening large populations. DPNCheck has been validated in multiple clinical studies.

Business Strategy

Our leading commercial products, and the focus of our strategic attention, are Quell and DPNCheck.

Quell is our wearable neuromodulation technology for chronic pain. It has been refined over the past seven years with feedback from over 200,000 chronic pain patients and is protected by over 20 U.S. utility patents. Patients control and personalize the technology with a mobile phone app, and their utilization of the devices and certain clinical metrics may be tracked in the Quell Health Cloud. The degree of technological sophistication, combined with our extensive consumer experience and the compelling results of clinical studies, gives us the opportunity to leverage this technology base into a portfolio of Quell-based prescription ("Rx") wearable neurotherapeutics.

Quell received Breakthrough Device Designation from the FDA for a fibromyalgia indication in 2021 leading to the FDA granting a De Novo marketing authorization for the use of Quell as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. This Rx product was introduced to the domestic market in late 2022 under a controlled, strategic commercial launch with the objectives to develop an effective Rx fulfillment process, identify the higher-potential market sectors and an efficient marketing approach, and implement a cost-effective sales model. This led to the engagement of Health Warehouse as our on-line pharmacy, the introduction of a telemedicine option to facilitate patient prescriptions, higher electrode refill pricing, a focus on Veterans Administration patients and a shift to variable cost contractor sales versus an employee sales force. Many of these commercial efforts are being implemented. The Company is considering the reactivation of its promotion of Quell OTC for lower extremity chronic pain during the fourth quarter of 2024 or early 2025.

Quell also received FDA Breakthrough Device Designation in early 2022 for the treatment of chronic Chemotherapy Induced Peripheral Neuropathy ("CIPN"). A CIPN double-blind, randomized, sham-controlled clinical study employing Quell, funded by the National Cancer Institute and the NIH, was completed in 2023. A 510(k) marketing application was submitted to FDA in late 2023; however, after evaluating the unique characteristics of the oncology market, the Company decided to follow the De Novo model that was used for Quell-fibromyalgia. A De Novo application for marketing Quell-CIPN to patients with moderate to severe neuropathic pain and cramps is planned for filing in late 2024 or early 2025. This would be the second product in our emerging portfolio of Quell-based Rx wearable therapeutics. We anticipate a similar approach to other disease indications involving chronic pain. These potentially include Fibromyalgia-like Long COVID, Chronic Low Back Pain, and Chronic Overlapping Pain Conditions.

DPNCheck is our well-established testing technology for peripheral neuropathies. This technology has been evaluated in multiple clinical studies and promoted both in the domestic Medicare Advantage ("MA") market and also in the Asian markets of Japan and China. MA has historically contributed the majority of DPNCheck revenue and been the driver of product-line growth.

During 2023, the Centers for Medicare and Medicaid ("CMS") implemented significant changes to its MA Hierarchical Condition Categories ("HCC") risk adjustment payments and to its MA Risk Adjustment Data Validation ("RADV") audit practices. The changes to HCC risk factor coding significantly reduced CMS payments for population screening for various conditions, including for neuropathy, and resulted in a significant reduction in our DPNCheck sales. As a result, we have reduced our commercial sales team while continuing to support our customer base and attract new accounts. It is unlikely that there will be a near-term recovery from the decline in revenue of the DPNCheck MA business. DPNCheck sales in Asian markets are not affected by the reimbursement changes in MA.

Production and marketing of ADVANCE, a legacy, point-of-care neurodiagnostic technology primarily used for the diagnosis and screening for carpal tunnel syndrome, was discontinued in 2012. Our support to an eroding customer base of ADVANCE was terminated on July 31, 2024.

Strategy Review

The Company has initiated a review of its strategic options to promote growth of Quell and DPNCheck and to maximize shareholder value. The review covers a wide range of options including potential changes in marketing strategies, the acquisition of new assets, potential sale of Company assets, and a merger or other strategic transaction. A timetable for completion of this process has not been set and the Company will continue to promote its commercial operations while the review is being conducted. The Company has utilized outside professional services in conducting its review, expanded its Board of Directors, curtailed its equity offerings, and implemented a reduction-in-force to reduce its operating costs. As of the date of this Quarterly Report on Form 10-Q, there have been no other material strategic transactions or decisions that would warrant disclosure.

Results of Operations

Comparison of Quarters Ended September 30, 2024 and 2023


	Quarter ended September 30,						Increase (Decrease)
	2024			2023			Amount		Percent

Revenues	$	587,314		$	1,203,164		$	(615,850)	(51.2)	%
Gross profit	311,957			781,782			$	(469,825)	(60.1)	%
–% of revenues	53.1		%	65.0		%			(11.9)	%
Operating expenses	2,054,005			2,742,680			$	(688,675)	(25.1)	%
Other income, net	233,822			192,161			$	41,661	21.7	%
Net loss	$	(1,508,226)		$	(1,768,737)		$	(260,511)	(14.7)	%
Net loss per common share	$	(0.75)		$	(1.66)		$	(0.91)	(54.8)	%

Revenues

Revenues for the third quarter of 2024 decreased by $616 thousand or 51.2% from the third quarter of 2023. DPNCheck sales accounted for the majority of revenues in both quarters and were the primary contributor to the revenue decline in the third quarter of 2024. The DPNCheck sales decline was primarily attributable to adverse CMS reimbursement changes in the Medicare Advantage market initiated in 2023 and scheduled to be phased in over a three year period which have reduced patient screening by healthcare providers for various conditions, including neuropathy. International sales of DPNCheck also declined from the prior year quarter due to excess inventory at the Japan distributor. The Company believes this situation is transient, and these biosensor orders should resume in the first quarter of 2025. Quell sales made a small contribution to offsetting the DPNCheck sales reduction in the third quarter of 2024.

Gross Profit

Gross profit for the third quarter of 2024 decreased by $470 thousand or 60.1% from the third quarter of 2023. Gross profit reflected a 53.1% gross margin rate in comparison with 65.0% in the prior year quarter. The decline in revenue, particularly DPNCheck revenue, was the largest contributor to the reduction in gross profit. The gross profit rate contraction reflected reduced weighting by DPNCheck, the Company’s highest margin product line.

Operating Expenses

Operating expenses declined in the third quarter of 2024 by $689 thousand or 25.1% from the third quarter of 2023. The primary contributors were cost benefits from the reduction in employee headcount in the first quarter of 2024 partially offset by increased professional service fees related to the business strategy review. Research and development spending in the third quarter of 2024 of $300 thousand decreased by $293 thousand from 2023 due primarily to a reduction in personnel costs of $275 thousand. Sales and marketing spending of $441 thousand decreased by $503 thousand from 2023 due primarily to a reduction of personnel costs of $374 thousand from 2023. General and administrative costs of $1.3 million increased by $107 thousand from 2023 reflecting higher professional fees of $122 thousand largely attributable to the business strategy review (legal and banking fees).

Net loss

The net loss in the third quarter of 2024 of $1.5 million decreased by $261 thousand from the third quarter of 2023. Net loss per common share was ($0.75) versus ($1.66) per common share in the third quarter of 2024. Per share amounts reflect 2.0 million shares outstanding in the third quarter of 2024 versus 1.1 million shares outstanding in the third quarter of 2023.

Comparison of Nine Months Ended September 30, 2024 and 2023


	Nine months ended September 30,						Increase (Decrease)
	2024			2023			Amount		Percent

Revenues	$	2,450,018		$	4,583,679		$	(2,133,661)	(46.5)	%
Gross profit	$	1,320,893		$	3,099,439		$	(1,778,546)	(57.4)	%
–% of revenues	53.9		%	67.6		%			(13.7)	%
Operating expenses	$	8,145,587		$	8,393,861		$	(248,274)	(3.0)	%
Other income, net	$	798,962		$	414,482		$	384,480

SEC Form 10-Q filed by NeuroMetrix Inc.