Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF

THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): January 8, 2025

Neuraxis, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-41775

45-5079684

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

11611 N. Meridian St, Suite 330

Carmel, IN 46032

(Address of principal executive offices)

Registrant’s telephone number, including area code: (812) 689-0791

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 par value		NRXS		NYSE American

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ☐

Item 2.02 Results of Operations and Financial Condition

On January 8, 2025, Neuraxis, Inc. (the “Company”) issued a press release (the “Press Release”) announcing its preliminary unaudited information about the Company’s estimated revenues for the three and twelve months ended December 31, 2024. A copy of the Press Release is furnished as Exhibit 99.1 and is incorporated herein by reference.

The preliminary financial information contained in the Press Release is unaudited and preliminary and does not present all information necessary for an understanding of the Company’s financial condition as of December 31, 2024 or its results of operations as of such date. This preliminary financial information is subject to completion of the Company’s normal financial close procedures. These procedures and the audit of the Company’s financial statements for the year ended December 31, 2024 are ongoing and could result in changes to the preliminary financial information.

The information contained in Item 2.02 (including Exhibit 99.1) shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and such information is not incorporated by reference into any registration statements or other document filed under the Securities Act of 1933, as amended or the Exchange Act, regardless of the general incorporation language contained in such filing, except as shall be expressly set forth by specific reference to this filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

Number

Exhibits

99.1

Neuraxis, Inc. press release dated January 8, 2025, announcing Preliminary Unaudited Fourth Quarter 2024 Results.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 8, 2025	NEURAXIS, INC.

	By:	/s/ Brian Carrico
	Name:	Brian Carrico
	Title:	President and Chief Executive Officer

Exhibit 99.1

NeurAxis Inc. Announces Strong Preliminary Unaudited Fourth Quarter 2024 Results; Revenues Increased 50% Year-Over-Year

●

Revenues in 4Q24 increased approximately 50% versus 4Q23

●

Cash balance as of 12/31/24 was approximately $3.7 million

Carmel, Ind., (January 8, 2025) (GLOBE NEWSWIRE) – NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, today announced preliminary, unaudited revenues for the three and twelve months ended December 31, 2024. Revenues for 4Q24 were approximately $800 thousand, an increase of 50% compared to 4Q23. Revenues for FY2024 were approximately $2.7 million, an increase of 11% compared to FY2023. The Company had a cash balance of approximately $3.7 million as of 12/31/24.

Brian Carrico, Chief Executive officer of NeurAxis commented: “We are pleased with our continued strong revenue growth in 4Q24. Our revenues increased approximately 50% in 4Q24, an acceleration compared to the 40% growth we achieved in 3Q24. In 2024, we successfully achieved our growth objectives for IB-Stim, building on the foundation that robust, peer-reviewed data, drives insurance expansion, fostering sustainable revenue and margin growth. Our Percutaneous Electrical Nerve Field Stimulation (PENFS) technology is now supported by 16 peer-reviewed studies conducted in leading U.S. children’s hospitals. These publications have significantly expanded insurance coverage to approximately 45 million lives, a substantial increase from 4 million just a year ago. This broader coverage contributed to the strong revenue growth in the second half of 2024.”

We expect continued robust revenue growth in 2025 and beyond, driven by expanding insurance coverage policy, the recently announced FDA 510(k) clearance for an expanded indication of IB-Stim that now includes patients aged 8 to 21 years, compared to the previous range of 11 to 18 years, as well as new Category I Current Procedural Terminology (CPT) code for PENFS procedures. In addition, in 1Q25, we will begin the commercialization of our Rectal Expulsion Device (RED), which recently received FDA approval.

Importantly, we believe we are well positioned to achieve our near-term growth objectives with our strengthened balance sheet, including reaching cash flow breakeven. Our focus remains on strong growth combined with a prudent expense structure, which should result in shareholder value.”

About NeurAxis, Inc.

NeurAxis, Inc., is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive the adoption of its IB-Stim™ therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim™ is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway. For more information, please visit http://neuraxis.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, the conditions in the U.S. and global economy, the trading price and volatility of the Company’s stock, public health issues or other events, the Company’s compliance with applicable laws, the results of the Company’s clinical trials and perceptions thereof, the results of submissions to the FDA, the results of the shareholder vote to enable the issuance of the Preferred Stock, and factors described in the Risk Factors section of NeurAxis’s public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise.

Contacts:

Company

NeurAxis, Inc.

info@neuraxis.com

Investor Relations

Lytham Partners

Ben Shamsian

646-829-9701

shamsian@lythampartners.com

Cover	Jan. 08, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 08, 2025
Entity File Number	001-41775
Entity Registrant Name	Neuraxis, Inc.
Entity Central Index Key	0001933567
Entity Tax Identification Number	45-5079684
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	11611 N. Meridian St
Entity Address, Address Line Two	Suite 330
Entity Address, City or Town	Carmel
Entity Address, State or Province	IN
Entity Address, Postal Zip Code	46032
City Area Code	(812)
Local Phone Number	689-0791
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.001 par value
Trading Symbol	NRXS
Security Exchange Name	NYSEAMER
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false