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NeurAxis Reports Second Quarter 2023 Financial Results

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 

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