UNITED STATES
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WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
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| Item 2.02 | Results of Operations and Financial Condition |
On September 21, 2023, Neuraxis, Inc. (the “Company”) announced its financial results for the second quarter ended June 30, 2023. A copy of the press release is furnished as Exhibit 99.1 and is incorporated herein by reference.
| Item 7.01. | Regulation FD Disclosure. |
The Company also prepared an investor presentation containing certain information and financial highlights about the Company and its industry. A copy of the presentation materials is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
The information contained in Item 2.02 and Item 7.01 (including Exhibits 99.1 and 99.2) 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 September 21, 2023, announcing second quarter 2023 financial results. | |
| 99.2 | Neuraxis, Inc. Investor Presentation (September 21, 2023). | |
| 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: September 21, 2023 | NEURAXIS, INC. | |
| By: | /s/ Brian Carrico | |
| Name: | Brian Carrico | |
| Title: | President and Chief Executive Officer | |
Exhibit 99.1
NeurAxis Reports Second Quarter 2023 Financial Results
Carmel, Ind., September 21, 2023 (GLOBE NEWSWIRE) – NeurAxis, Inc. (NYSE American: NRXS) (“NeurAxis” or the “Company”), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today reported financial results for the second quarter ended June 30, 2023.
Recent Highlights:
| ● | Announced a poster presentation titled, “Percutaneous Electrical Nerve Field Stimulation Saves Cost to Parents and Insurers of Adolescents with Irritable Bowel Syndrome”, from the University of Michigan at the 2023 American Neurogastroenterology and Motility Society (ANMS) Annual Meeting, highlighting the cost-effectiveness of its PENFS or IB-Stim™ therapy in the treatment of irritable bowel syndrome in adolescents. Noting: |
| ○ | IB-Stim™ therapy increases the number of healthy days, based on effective treatment of abdominal pain symptoms, in adolescents suffering from IBS; |
| ○ | Treatment with IB-Stim™ results in approximately 60% or $4,744 of potential cost-savings to insurers; and |
| ○ | IB-Stim™ treatment also offers the potential cost-saving opportunity of approximately 53% or $5,802 to patients’ families. |
| ● | Highlighted two recently published independent studies showing that IB-Stim™ therapy leads to improvements in abdominal pain and disability in adolescents with IBS and that the gut microbiome may play an important role. |
| ● | Announced the publication of Prospective study of the effect of auricular percutaneous electrical nerve field stimulation on quality of life in children with pain related disorders of gut-brain interaction, a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of IB-Stim™ in children with post-concussion symptoms, featured in the September 2023 Frontiers in Pain Research. Noting: |
| ○ | Patients (n=31) reported significant reductions in abdominal pain, nausea, disability, and anxiety from baseline to week 4 (p < 0.05); |
| ○ | Parent assessments reported significant improvement in the child’s quality of life based on physical function, psychosocial function, and generic core scale scores (p < 0.05); and |
| ○ | Parents also reported reduced abdominal pain, functional disability, and somatization in their child. The global health scores also significantly improved based on both patient and parent reports (p < 0.05). |
| ● | Completed initial public offering of common stock which raised net proceeds of approximately $6.1 million. |
“We are thrilled with the progress we have made, especially now as a public company, with funds raised to steadily drive our momentum,” said Brian Carrico, President and Chief Executive Officer of NeurAxis. “The support we are receiving, including our recently highlighted 10th peer reviewed publication, out of a total 14 publications to-date, demonstrates our continuing commitment to grow our body of clinical evidence. Further, as we approach our target of 16 publications, we believe the foundation of strong clinical evidence we have positions us for expanded payor coverage and the adoption of IB-Stim™. We look forward to our continuing progress to grow our business, in line with our goal to make IB-Stim™ the standard of care for children with abdominal pain related disorders of the gut-brain interactions.”
| 1 |
Second Quarter 2023 Financial Results
Revenue for the second quarter of 2023 was $646.0 thousand, representing a decrease of 5% compared to $682.6 thousand in the second quarter of 2022. The decrease was primarily due to ordering patterns of our major customers.
Gross profit for the second quarter of 2023 was $578.2 thousand, representing a decrease of 4% compared to a gross profit of $603.6 thousand in the second quarter of 2022. Gross margin totaled 89.5% in the second quarter of 2023, compared to 88.4% in second quarter of 2022. The increase was primarily due to slightly lower cost of sales.
Selling expenses for the second quarter of 2023 were $78.8 thousand, compared to $127.4 thousand in the second quarter of 2022. The decrease was primarily due to lower commission costs, with the commission rate being lowered at the beginning of 2023.
Second quarter research and development expenses were $109.8 thousand, compared to $13.7 thousand in the second quarter of 2022, reflecting increased spend primarily on new product development.
General and administrative expenses for the second quarter of 2023 were $1,507.2 thousand, compared to $1,132.1 thousand in the second quarter of 2022. The increase was primarily due to higher professional fees.
Second quarter net loss was ($2,235.6) thousand, or ($1.21) per common share, compared to ($1,516.5) thousand, or ($0.87) per common share, for the same period of 2022.
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, as well as 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.
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 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.
Contacts:
Company
NeurAxis, Inc.
info@neuraxis.com
Investor Relations
Gilmartin Group
IR@neuraxis.com
| 2 |
NeurAxis, Inc.
Condensed Statements of Operations
(unaudited)
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Net Sales | $ | 646,021 | $ | 682,581 | $ | 1,451,131 | $ | 1,452,848 | ||||||||
| Cost of Goods Sold | 67,813 | 79,009 | 163,713 | 154,209 | ||||||||||||
| Gross Profit | 578,208 | 603,572 | 1,287,418 | 1,298,639 | ||||||||||||
| Selling Expenses | 78,791 | 127,424 | 186,723 | 263,304 | ||||||||||||
| Research and Development | 109,789 | 13,665 | 126,586 | 58,063 | ||||||||||||
| General and Administrative | 1,507,169 | 1,132,065 | 2,987,923 | 2,160,161 | ||||||||||||
| Operating Loss | (1,117,541 | ) | (669,582 | ) | (2,013,814 | ) | (1,182,889 | ) | ||||||||
| Other Income (Expense): | ||||||||||||||||
| Financing charges | — | (872,763 | ) | (2,772 | ) | (872,763 | ) | |||||||||
| Interest expense | (194,690 | ) | (34,450 | ) | (356,378 | ) | (60,550 | ) | ||||||||
| Change in fair value of warrant liability | (36,050 | ) | 61,520 | 198,757 | (569,561 | ) | ||||||||||
| Change in fair value of derivative liability | 860 | — | 192,157 | — | ||||||||||||
| Amortization of debt discount and issuance cost | (887,937 | ) | (12,944 | ) | (3,550,592 | ) | (12,944 | ) | ||||||||
| Extinguishment of debt liabilities | — | — | 1,129,498 | — | ||||||||||||
| Other income | 2 | 11,689 | 1,552 | 11,956 | ||||||||||||
| Other expense | (258 | ) | — | (7,430 | ) | — | ||||||||||
| Total other income (expense), net | (1,118,073 | ) | (846,948 | ) | (2,395,208 | ) | (1,503,862 | ) | ||||||||
| Net Loss | $ | (2,235,614 | ) | $ | (1,516,530 | ) | $ | (4,409,022 | ) | $ | (2,686,751 | ) | ||||
| Per-share Data | ||||||||||||||||
| Basic and diluted loss per share | $ | (1.21 | ) | $ | (0.87 | ) | $ | (2.39 | ) | $ | (1.56 | ) | ||||
| Weighted Average Shares Outstanding | ||||||||||||||||
| Basic and diluted | 2,003,322 | 1,970,054 | 2,003,322 | 1,970,054 | ||||||||||||
| 3 |
NeurAxis, Inc.
Condensed Balance Sheet
(unaudited)
| June 30, | ||||||||
| 2023 (Unaudited) | December 31, 2022 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 51,440 | $ | 253,699 | ||||
| Accounts receivable, net | 237,170 | 174,399 | ||||||
| Inventories | 44,205 | 48,133 | ||||||
| Prepaids and other current assets | 21,333 | 726 | ||||||
| Total current assets | 354,148 | 476,957 | ||||||
| Property and Equipment, at cost: | 417,912 | 405,845 | ||||||
| Less - accumulated depreciation | (332,651 | ) | (317,834 | ) | ||||
| Property and equipment, net | 85,261 | 88,011 | ||||||
| Other Assets: | ||||||||
| Deferred offering costs | 941,143 | 736,736 | ||||||
| Operating lease right of use asset | 85,823 | 101,382 | ||||||
| Intangible assets, net | 73,316 | 77,558 | ||||||
| Total Assets | $ | 1,539,691 | $ | 1,480,644 | ||||
| Liabilities | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 2,438,117 | $ | 1,592,116 | ||||
| Accrued expenses | 1,174,381 | 834,062 | ||||||
| Notes payable | 249,389 | 202,834 | ||||||
| Current portion of operating lease payable | 41,261 | 33,395 | ||||||
| Notes payable - related party | 58,051 | 58,051 | ||||||
| Notes payable - convertible notes, net of unamortized discount of $4,421,424 and $3,327,213 as of June 30, 2023 and December 31, 2022 | 1,217,465 | 228,342 | ||||||
| Customer deposits | 61,317 | 59,174 | ||||||
| Derivative liabilities | 2,275,029 | 1,735,700 | ||||||
| Warrant liabilities | 3,916,884 | 2,234,384 | ||||||
| Total current liabilities | 11,431,894 | 6,978,058 | ||||||
| Non-current Liabilities: | ||||||||
| Operating lease payable, net of current portion | 51,635 | 76,199 | ||||||
| Note payable, net of current portion | 38,797 | — | ||||||
| Total non-current liabilities | 90,432 | 76,199 | ||||||
| Total liabilities | 11,522,326 | 7,054,257 | ||||||
| Commitments and contingencies (see note 14) | ||||||||
| Stockholders’ Deficit | ||||||||
| Convertible Series A Preferred stock, $0.001 par value; 1,000,000 shares authorized; 506,637 issued and outstanding as of June 30, 2023 and December 31, 2022 | 507 | 507 | ||||||
| Convertible Series Seed Preferred Stock, $0.001 par value; 120,000 shares authorized; 115,477 issued and outstanding as of June 30, 2023 and December 31, 2022 | 115 | 115 | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized; 1,963,322 issued and outstanding as of June 30, 2023 and December 31, 2022 | 1,963 | 1,963 | ||||||
| Additional paid in capital | 28,355,230 | 28,355,230 | ||||||
| Accumulated deficit | (38,340,450 | ) | (33,931,428 | ) | ||||
| Total stockholders’ deficit | (9,982,635 | ) | (5,573,613 | ) | ||||
| Total Liabilities and Stockholders’ Deficit | $ | 1,539,691 | $ | 1,480,644 | ||||
| 4 |
NeurAxis, Inc.
Condensed Statement of Cash Flows
(unaudited)
| For the Six Months Ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Cash Flows from Operating Activities | ||||||||
| Net Loss | $ | (4,409,021 | ) | $ | (2,117,190 | ) | ||
| Adjustments to reconcile net loss to net cash used by operating activities: | ||||||||
| Amortization of debt discount and issuance cost | 3,550,592 | 12,944 | ||||||
| Depreciation and amortization | 20,060 | 16,695 | ||||||
| Provisions for losses on accounts receivable | 3,927 | 29,580 | ||||||
| Non-cash lease expense | 15,559 | 13,296 | ||||||
| Stock based compensation | — | 24,121 | ||||||
| Extinguishment of debt liability | (1,129,498 | ) | — | |||||
| Finance Charges | 2,772 | 872,763 | ||||||
| Change in fair value of derivative liabilities | (192,157 | ) | — | |||||
| Change in fair value of warrant liabilities | (198,757 | ) | 569,563 | |||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (66,698 | ) | (131,764 | ) | ||||
| Inventory | 3,928 | (13,616 | ) | |||||
| Prepaids and other current assets | (20,607 | ) | (138 | ) | ||||
| Accounts payable | 846,001 | (118,561 | ) | |||||
| Accrued expenses | 340,317 | 266,486 | ||||||
| Customer deposits | 2,143 | (12,720 | ) | |||||
| Operating lease liability | (16,698 | ) | (13,791 | ) | ||||
| Net cash used by operating activities | (1,248,137 | ) | (1,171,895 | ) | ||||
| Cash Flows from Investing Activities | ||||||||
| Additions to property and equipment | (12,067 | ) | — | |||||
| Additions to intangible assets | (1,000 | ) | (49,815 | ) | ||||
| Net cash used by investing activities | (13,067 | ) | (49,815 | ) | ||||
| Cash Flows from Financing Activities | ||||||||
| Principal payments on notes payable | (2,724,479 | ) | (86,453 | ) | ||||
| Proceeds from notes payable | 159,831 | — | ||||||
| Proceeds from convertible notes, net of fees | 3,828,000 | 1,087,500 | ||||||
| Offering costs paid | (204,407 | ) | (26,549 | ) | ||||
| Net cash used in financing activities | 1,058,945 | 974,498 | ||||||
| Net Decrease in Cash and Cash Equivalents | (202,259 | ) | (247,212 | ) | ||||
| Cash and Cash Equivalents at Beginning of Period | 253,699 | 320,858 | ||||||
| Cash and Cash Equivalents at End of Period | $ | 51,440 | $ | 73,646 | ||||
| Supplemental Disclosure of Non-cash Cash Activities | ||||||||
| Cash paid for interest | $ | 57,202 | $ | 55,550 | ||||
| Cash paid for income taxes | — | — | ||||||
| Supplemental Schedule of Non-cash Investing and Financing Activities | ||||||||
| Fair value of warrant liabilities of warrants from convertible notes | $ | 1,881,257 | $ | 884,118 | ||||
| Fair value of derivative liabilities of conversion feature from convertible notes | 1,860,984 | 1,075,098 | ||||||
| 5 |
Exhibit 99.2
