health news

CARMEL, Ind., Sept. 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.”

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


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  

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  



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